Comparative study between the outcome of Laparoscopic and Open Varicocelectomy

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Comparative study between the outcome of Laparoscopic and Open Varicocelectomy

1.1 Background

Varicocele is the dilatation and tortuosity of the testicular and pampiniform plexus around the testis caused by retrograde blood flow through the internal spermatic vein. Varicocele occurs in approximately 15% of adult men (Hirsch et al 1998). The presenting symptoms may vary and include scrotal heaviness or discomfort, pain and ill-defined mass and growth retardation of the ispilateral testis. The indications for surgical repair include pain, discomfort and infertility.

Varicocele is the one of the most common cause of male infertility and in up to 40% cases evaluated of subfertility levels (Budair, 2003). It also may cause scrotal pain and discomfort in 2-10% cases, which diminishes performance during daily activities to varying degrees in affected men (Peterson, 1998). Conservative treatments including limitation of physical activites, scrotal elevation and non-steroidal anti-inflammatory analgesics often offer no benefits in pain management. Varicocelectomy is an alternative treatment for these patients. The impact of varicocele treatment in terms of increased pregnancy rates in infertile couple is a controversial issue. A significant increase in the pregnancy rate in patients who undergo varicocele treatments is reported in previous studies.

Continuous effort is given to understand the pathophysiology of varicocele to evaluate the outcome predictor, to identify the indications of intervention and best way of intervention.

The ideal method of varicocele treatment is another debatable issue. Several methods have been used including open surgical ligation of the spermatic vein, retrograde or antegrade sclerothrapy and laparoscopic and microsurgical varicocelectomy (Abdulmaaboud et al.1998). Each technique has merits and demerits and conflicting results have been achieved in different studies. Choice of technique is mostly guided by expertise and facilities available.

As soon as the increasing number of surgical procedures performed by laparoscopy heralded a new era of minimally invasive treatments, the laparoscopic feasibility of almost all the open surgical techniques was evaluated. Urology had a history similar to that in many other surgical specialties in that various attempts were made to switch the current open surgical techniques into laparoscopic operations, with very different results. Some procedures proved to be awkward experiences, therefore remaining isolated attempts; others were successful although unreliable and nonreproducible, whereas most had impressive results. Among the last group is laparoscopic spermatic vein ligation.

The first laparoscopic varicocelectomy was introduced by Sanchez de Badajoz et al. in 1988 (McManus et al 2004). Generally, laparoscopic varicocelectomy is believed to offer certain benefits for patients compared to the open operative method. However, the advantage of a laparoscopic technique is particularly evident when the open alternative needs large skin incisions and the patient takes a longer time to recover, as it is the case with either nephrectomy or adrenalectomy. However, the open surgical technique of varicocelectomy requires only a small incision, with the patient recovering in few days, need less operation time, less cost. For these reason, the advantage of the laparoscopic technique is still debatable.

The common complications of varicocele surgery are persistence or recurrence of varicocele and hydrocele development. There is no consensus on which approach is best suited for varicocele surgery. Incidence of complication and outcome depends on procedure performed and desired result is not always achieved. Previous study revealed wide variation ranging from no improvement in semen quality to significant improvement, and variable percentage of spontaneous pregnancy in infertile male after varicocelectomy (Biggers et al 1981; Schlesinger et al 1994).

In Bangladesh, infertility is now a growing problem, and male infertility is major cause and no data are available regarding the outcome of fertility after varicocelectomy. Consequently, it should be determined, which is the best technique to cure the disease. Thus, present study was designed to compare the outcome of laparoscopic and open inguinal varicocelectomy.

1.2 Rationale

Varicocele occurs in approximately 15% of adult men. It is the one of the most common cause of male infertility and in up to 40% cases evaluated of subfertility levels. Varicocele also may cause scrotal pain and discomfort in 2-10% cases, which diminishes performance during daily activities to varying degrees in affected men. Varicocele causes a progressive deterioration in testicular function and semen quality, ranging from oligospermia to complete azoospermia. The impact of varicocele treatment in terms of increased pregnancy rates in infertile couple is a controversial issue. A significant increase in the pregnancy rate in patients who undergo varicocele treatments is reported in previous studies.

The ideal method of varicocele treatment is a controversial issue. Several methods have been used including open surgical ligation of the spermatic vein, retrograde or antegrade sclerothrapy and laparoscopic and microsurgical varicocelectomy. Each technique has merits and demerits and conflicting results have been achieved in different studies. Choice of technique is mostly guided by expertise and facilities available.

As soon as the increasing number of surgical procedures performed by laparoscopy heralded a new era of minimally invasive treatments, the laparoscopic feasibility of almost all the open surgical techniques was evaluated. In Urology, various attempts were made to switch the current open surgical techniques into laparoscopic operations, with very different results. Some procedures proved to be awkward experiences; some were successful although unreliable and non-reproducible, whereas most had impressive results. Among the last group is laparoscopic spermatic vein ligation. The first laparoscopic varicocelectomy was performed in 1988 and has gained popularity.

Generally, laparoscopic varicocelectomy is believed to offer certain benefits for patients compared to the open operative method. However, the open surgical technique of varicocelectomy requires only a small incision, with the patient recovering in few days, need less operation time, less cost. For these reason, the advantage of the laparoscopic technique is still controversial.

There is no consensus on which approach is best suited for varicocele surgery. Incidence of complication and outcome depends on procedure performed and desired result is not always achieved. Previous study revealed wide variation ranging from no improvement in semen quality to significant improvement, and variable percentage of spontaneous pregnancy in infertile male after varicocelectomy.

In Bangladesh, infertility is now a growing problem, and no data are available regarding the outcome of fertility after varicocelectomy. Bangladesh is a developing country and Laparoscopic varicocelactomy is expensive, needs general anesthesia. Consequently, it should be determined which is the best technique regarding cure of the disease, cost-effectiveness, hospital stay, postoperative complication including recurrence. Thus, present study was designed to compare the outcome of laparoscopic and open inguinal varicocelectomy.

1.3 Hypothesis

Open varicocelectomy is superior to laparoscopic varicocelectomy.

1.4 Objectives:

General:

To evaluate and compare the short-term outcome of open and laparoscopic approach of varicocelectomy.

Specific:

1. To assess and compare pre and post-operative semen quality.

2. To assess and compare pre and post-operative pain score.

3. To determine and compare the operative time, postoperative hydrocele and recurrence rate of varicocele.

2.1 Historical Background

According to Spancer (1938 cited Saypol, 1981), Celsus credited the Greeks with the first description of a varicocele in De Medicina, written during the first century AD. He found that varicocele makes testicular atrophy. Abol-ghasem Khalaf Zahravi (Albucasis) mentioned this subject and added that Celsus suggested orchidectomy for testis atrophy due to varicocele through scrotal incision parallel to the penis.

Varicocele was first recognized as a clinical problem in the 16th century. Ambroise Pare (1500-1590), the most celebrated surgeon of the Renaissance described this vascular abnormality as the result of melancholic blood. Barfield, a British surgeon, first proposed the relationship between infertility and varicocele in the late 19th century. Shortly thereafter, other surgeons reported that varicocele is associated with an arrest of sperm secretion and the subsequent restoration of fertility following repair. Through the early 1900s, reports by other surgeons continued to describe the association of varicocele with infertility.

Barwell (1885 cited Grasso, 2000) operated on 100 patients with varicocele by placing a wire loop around the dilated veins. Tulloch’s report (1955) was the first to draw significant attention to the problem where an azoospermic patient with bilateral varicoceles, whose postoperative sperm count was 27 million, and whose wife subsequently became pregnant. After that, the idea of surgically correcting varicoceles as a clinical approach to certain kinds of male infertility gained support among American surgeons. Research continued, leading to many published studies that associated varicoceles with impaired semen quality.

The pathophysiology of varicoceles has been questioned for years. Skepticism has persisted because the deleterious effects of varicocele on spermatogenesis, as well as the beneficial effects after varicocelectomy are unpredictable. With the improvements in assisted reproductive techniques, some investigators have questioned the role of varicocelectomy for treating men for this condition (Kumar, 2006).

While its exact origins remain unknown, the basic pathology of varicocele is clear: it involves venous dilatation of internal spermatic veins and pampiniform plexus. Primary varicoceles involve defective valves, while secondary varicoceles result from venous compression by outside factors such as retroperitoneal tumors. Microscopic evaluation of spermatic vein fragments has revealed alterations in the longitudinal muscle layers, in addition to a decrease in the number of nerve elements and “vasa vasorum” in the vessel wall (Tilki et al., 2007). These findings suggest a defective contractile mechanism of blood transport through the pampiniform plexus. In addition, hydrostatic pressure has been shown to increase by as much as five-fold in vasography studies of the spermatic veins. This reverses the pressure gradient, thereby leading to a hypoxic state (Gat et al., 2006).

There are several reasons why it is difficult to find good data on the outcome of varicocele surgery. Semen analysis is used as a surrogate marker for the fertility potential of the male. The WHO has recommended values for semen parameters that establish that a male is fertile. Unfortunately, the predictive value of these parameters is limited. Smith et al(1977)reported that up to 25% men with sperm densities below 12.5 million/ml could father a child through spontaneous conception. On the other hand, even with counts of up to 25million/ml, which is normal by the WHO standards, 10% of men could not father a child with a fertile female. These findings suggest that there may be parameters other than those assessed during a routine semen analysis that affect pregnancy and study outcomes based solely on improvement of semen parameters are not enough. Semen parameters themselves tend to show a wide variation among the same individual through the day, week, month and season. The use of one, or even two, semen analyses may thus not be representative of the true fertility potential of an individual (Mallidis et al. 1991). Finally, there is enormous variation in the quality of semen analysis reported by various laboratories. A more effective outcome parameter would be pregnancy rates since pregnancy is the ultimate end-point of therapy. When using pregnancy as the end-point of treatment outcome, it is important to consider the spontaneous pregnancy rate in supposedly infertile couples on no therapy (Collins et al., 1983). The spontaneous pregnancy rate is about 1% per month, reaching cumulatively to 26% over 3 years (Siddiq and Sigman, 2002). Obviously, any treatment option being used should improve upon this result. Varicocelectomy results are incremental and pregnancies may occur even 2 years after the surgery. It is rare to find trials that are able to provide extensive and close follow-up.

In order to accept that there can be clinical benefit from treating varicoceles for infertility, there must exist an acceptable hypothesis for their deleterious effects. Earlier studies dealing with changes in scrotal temperature did not clearly indicate how this actually affected local physiology and biochemistry. Recent laboratory work has demonstrated various changes that may occur at the molecular level due to the effect of varicoceles. There is increasing interest in the role of reactive oxygen species (ROS) and oxidative stress in the causation of male infertility. However, their uncontrolled production is detrimental to cell function and there exists a large battery of cellular molecules called antioxidants that protect the cell from excessive ROS-induced lipid peroxidation (Sharma and Agarwal, 1996). Human spermatozoa are among the various cells capable of generating ROS. Excessive generation of ROS with inadequate compensatory rise in anti-oxidants is called oxidative stress. ROS cause damage to cell membranes by peroxidation of their lipid content. Spermatozoa are particularly susceptible to oxidative stress-induced damage because of the large polyunsaturated fat content in their membranes. Oxidative stress is also responsible for damage to the DNA structure of the spermatozoa

Varicocele may be one of the main mechanisms of action in inducing sub fertility. A clinical study found higher ROS levels in both fertile and infertile men with varicoceles compared with men without varicoceles, suggesting that varicoceles cause oxidative stress (Saleh, 2003).

In the adult, varicoceles may have an effect on the serum testosterone levels and thus affect fertility. In a study of 83 infertile men treated for varicoceles, mean serum testosterone concentration rose alter embolization by 43% while the free testosterone concentration rose by 72% (Gat et al. 2004). This was associated with a significant increase in the mean sperm concentration, motility and morphology.

Previous study revealed contradictory findings regarding outcome of varicocele surgery. Yenivol CO et al. (2003) conducted a retrospective study to evaluate the effectiveness of the high ligation performed for pain. Eighty seven patients were interviewed for resolution of pain and complications. Seventy two (82.8%) patients reported complete resolution, 8 (9.2%) patients reported partial response and 7 (8%) patients had persistent pain. They concluded that high ligation is effective in the treatment of painful varicocele and prospective randomized studies are needed comparing surgical and conservative treatment.

Peterson et al. (1998) evaluated in a retrospective study, included 35 patients and underwent different ligation techniques (the inguinal or subinguinal approach in 24, high ligation in 10 and laparoscopic repair in one) for painful varicocele. The complete resolution rate in their study was reported as 86%. Diggers and Soderdahl (1981) performed a retrospective study including 50 patients of painful scrotum due to left sided varicocele. They used high ligation technique only and reported success rate was 48%.

Karademir et al. (2005) conducted a study included 144 consecutive patients with left-sided varicocele who had left scrotal pain for more than 3 months. In their study, they assessed and compared pre-and postoperative scrotal pain in patients with varicocele who underwent varicocelectomy with different approaches. All patients underwent varicocele ligation using either a subinguinal or inguinal approach with or without external spermatic vein ligation. The surgery was successful in 101 (83.4%) of the 121 patients available for follow up. Seventy-four (61.1%) patients reported the complete resolution of pain while 27 patients (22.3%) reported partial resolution. Symptoms worsened in a single case and pain persisted postoperatively in 19 cases (15.7%). There were no statistically significant differences in the characteristics of the pain and grade of varicocele between postoperative groups. A significant difference was observed in postoperative success between patients who had external spermatic vein ligation and those who did not,’ regardless of the surgical approach (inguinal or subinguinal). The author concluded that varicocelectomy using either inguinal or subinguinal approaches was an effective and reasonable treatment option and should include external spermatic vein ligation for a satisfactory outcome.

Dubin and Amelar published a number of articles and consolidated their series of 986 cases followed-up for over 2 years. They noted an improved semen quality in 70% of patients. Another group of 272 patients with clinical varicoceles were reported to have a significant improvement in sperm count and sperm motility in nearly all cases (Jungwirth et al. 2001). In a report on 150 patients with infertility and varicoceles, 80% showed an improvement of semen analysis (Testini et al. 2001).

Agarwala et al. (2007) conducted a review to evaluate the efficacy varicocelectomy in improving semen parameters. They reported that the sperm concentration increased by 12.03 million/ml, and motility increased by 11.71% after high ligation. The improvement in sperm morphology was 3.13%. They concluded that varicocelectomy significantly improves semen parameters in clinically palpable varicocele and abnormal semen parameters.

Misseri et al. (2001) evaluated the incidence of hydrocele and delayed recurrent varicocele after varicocelectomy in a long-term follow-up. To determine the incidence of hydrocele, when they develop and whether the development was procedure related. They retrospectively reviewed records of 77 boys who underwent 95 varicocelectomies and had an examination at 06 months after surgery. Fifty-six patients underwent a standard Palomo procedure and 21 Ivanissevich repair. Of the 67 Palomo varicocelectoies 19 (24%) were complicated by hydroceles after surgery, compared with four of 28 (14%) Ivanissevich procedures (P=0.034).

To compare the outcomes of the different surgical techniques used in varicocelectomy Al-Kandari et al. (2007) conducted a prospective study including 120 patients with 147 clinically palpable varicoceles who underwent varicocelectomy. The patients were randomly allocated to one of three equal groups according to the varicocelectomy technique, which included the open inguinal approach, a laparoscopic approach, and subinguinal microscopic varicocelectomy. The assessment included operative and postoperative parameters, together with semen analysis and pregnancy rate. The mean follow-up was 18 months (range 11 to 26). At follow-up hydrocele was observed in 7 (13%) of 52 varicoceles in the open group and 10 (20%) of 50 in the laparoscopic group. In the open group 7 patients and in laparoscopic group 9 patients were developed recurrence of varicocele after surgery. This difference was not statistically significant. Improvement in sperm motility and/or concentration was comparable and observed in 65%, 67%, and 76% of the open, laparoscopic, and microscopic groups, respectively.

Hirsch et al. 1998 concluded in their study on 41 patients with varicocele that laparoscopic varicocelectomy has no advantage over inguinal varicocelectomy with respect to hospitalization, seeking analgesic, and going back to work. Moreover, laparoscopic varicocelectomy was longer and had more complications than open subinguinal approach.

2.2 Definition of varicocele

Varicocele is the dilatation and tortuosity of the pampiniform venous plexus of the spermatic cord.

2.3 Incidence of Varicocele:

Varicocele occurs in approximately 15% of adult men and more common in sub fertile population (40%).Varicoceles rarely become clinically evident before puberty. Oster (1971) surveyed 1072 schoolboys and found the incidence of varicocele to be 0% in those younger than 10 years and 16.2% in those 10 to 19 years old. Other studies have estimated the incidence between 10 and 17 years of age to be 9% to 25.8%, with an incidence in adulthood of approximately 15% (Skoog et al, 1997). Isolated left-sided lesions are seen in 78% to 93% of varicocele patients, and the unilateral right-sided incidence between 1% and 7%. The bilateral varicocele is found in 2% to 20% of cases (Dubin and Amelar, 1977). The reason for high incidence of varicocele in left side may be the longer left spermatic vein and its attachment to the left renal vein with a perpendicular angle just opposite the adrenal vein established behind the descending colon.

2.4 Etiology of varicocele

Etiology of varicocele is not known. The most acceptable theory is absence or insufficiency of internal spermatic vein valves and resulting venous reflux with its consequent results. However, Shafik (1973) suggested that varicocele is the result of cremasteric weakness and made scrotal placation for its treatment. Renogonadal bypass and nutcracker phenomenon is another theory for varicocele apprance.

2.5 Relevant Anatomy

The testes are the paired male genital organs that contain sperm, cells that produce and nourish sperm (spermatogonia and Sertoli cells respectively), and cells that produce testosterone (Leydig cells). The testes are located in a sac called scrotum. The epididymis is a small tubular structure attached to the testes that serves as a storage reservoir wherein sperm mature. Sperm travel through the vas deferens, which connects epididymis to prostate gland. The vas deferens is in the scrotum and is part of a larger tissue bundle called the spermatic cord. The spermatic cord contains the vas deferens, blood vessels, nerves, and lymphatic channels. The pampiniform plexus is composed of the veins of spermatic cord. These veins drain blood from the testes, epididymis and vas deferens and eventually become the spermatic veins that drain into the main circulation of the kidneys. The pampiniform plexus may become tortuous and dilated, much like a varicose vein in leg. Two other veins, the cremasteric and deferential also drain blood from testicles; however, they are rarely involved in the varicocele process.

Figure1:Arterial andvenous Draining of Testicles and Varicocele

2.6 Classification of varicocele

Varicocele may be clinical or subclinical. Clinical varicocele is detected by physical examination but subclinical varicocele is not visible or palpable at rest or during Valsalva maneuver but can be demonstrated by color Doppler ultrasound scan. Varicoceles can be primary or secondary. Common causes of secondary varicocele are renal cell carcinoma, retroperitoneal tumours, retroperitoneal fibrosis, liver cirrhosis caused by portal hypertension

2.7 Grading of varicocele

Clinical varicoceles have been classified into three grades. This has helped clinicians to determine the timing of the definitive treatment and prognosis. The grades are described as (Dubin and Amelar, 1970):

(1) Grade I = small size only palpable during Valsalva maneuver;

(2) Grade II = medium size palpable at rest, and

(3) Grade III = large size visible at rest.

2.8 Effects of Varicoceles on spermatogenesis

Most researchers believe that varicoceles are associated with deleterious effects on the testes, including the possible effects of pressure, oxygen deprivation, heat injury and toxins. Toxic effects of varicocele may cause

Testicular growth failure, semen abnormalities, Leydig cell dysfunction and histologic changes.

2.9 Clinical Findings

A patient with a varicocele is usually asymptomatic and often seeks an evaluation for infertility after failed attempts at conception. Most of the patients usually present with painless scrotal swelling. Only a minority of patients present with a dragging pain or discomfort that is relieved in supine position. The asymptomatic patients are discovered on routine physical examination performed for school entry, recruitment, or preseason sports participation.

Physical examination should be carried out in a warm room with the patient in both the supine and standing positions and with and without a valsalva maneuver. The classic description of the varices is the consistency of a “bag of worms” that decompresses when the patient is in the supine position. Ipsilateral testis may be smaller in comparison to the opposite.

2.10 Investigations

The diagnosis of varicocele is made by physical examination that remains the ‘gold standard” and may be confirmed by radiographically such as real-time scrotal ultrasonography and color Doppler ultrasonography, spermatic venography, radionuclide scanning and thermography. Seminal fluid analysiscan give an indication of the degree of impairment of testicular function.

Further investigations should be warranted in elderly patients with sudden onset of varicocele, right-sided varicoceles and a varicocele that is not reduced in the supine position to exclude intra-abdominal pathology (Peterson et al. 1998).

2.11 Treatment

Not all varicoceles need treatment. Small symptomatic varicocele may be treated conservatively with lifestyle modification, lifting of scrotum and NSAIDs. Varicocele surgery is indicated in patients with-

i) Testicular growth failure

ii) Abnormal semen parameter

iii) Painful scrotum.

2.11.1 Surgical Options

There are two approaches to varicocele repair: surgery and percutaneous approach. Surgical repair of a varicocele may be accomplished by various open surgical methods, including retroperitoneal, inguinal and subinguinal approaches, or by laparoscopy. Percutaneous treatment of a varicocele is accomplished by percutaneous embolization or sclerotherapy of the refluxing internal spermatic vein(s).

2.12 Complications of Varicocele Surgery

The most common complication following varicocelectomy is hydrocele formation. The incidence of postoperative hydrocele following the non microsurgical technique ranges from 3% to 33% with an average of 7%. Examination of the hydrocele fluid has shown that the fluid characteristics are consistent with obstruction of lymphatics. The effect of a hydrocele on sperm function and fertility is uncertain. Large size hydrocele requires surgical correction. Use of magnification to identify lymphatics and preserve them has nearly eliminated the incidence of hydrocele formation. Testicular artery injury is a complication of varicocelectomy. Although the testis also receives blood supply from the cremasteric and deferential arteries, ligation of the testicular artery may result in atrophy and/or impaired spermatogenesis. Varicocele recurrence occurs in periarterial, parallel inguinal, midretroperitoneal,or transscrotal collaterals. Parallel inguinal collaterals are missed with retroperitoneal repair. Routine inguinal techniques without optical magnification miss scrotal collaterals and small veins adherent to the testicular artery (Carin et al. 2004).

3. MATERIALS AND METHODS

3.1 Type of study

This was a quasi experimental study.

3.2 Place of Study

Department of urology, Dhaka Medical College Hospital, Dhaka,

DSK Hospital, Adabor, Dhaka.

3.3 Period of Study

From July 2010 to Jun 2012.

3.4 Study Population

Varicocele patients attended in the department of urolgy, Dhaka Medical College Hospital and DSK hospital. A total of 57 patients were evaluated during the study period in above mentioned institution and hospital.

3.5 Sample size determination:

It is expected that open varicocelectomy would cause a significant reduction of pain and scrotal swelling in 80% of the patients, while laparoscopic varicocelectomy would cause a reduction of disease activity in 60% of the patients. So the sample size at 5% level of significance and 80% power was calculated using the formula,

P₁(1 – P₁) + P₂(1 – P₂)

n = ———————————– × (Z_? + Z_?)² where,

(P₁ – P₂)²

P₁ = Proportion of patients responding to open varicocelectomy

= 80% = 0.80 (Weinblatt et al, 1985).

P₂ = Proportion of patients developing the outcome in laparoscopic varicocelectomy = 60% = 0.60.

Z_? = Z-value (two tail) at 5% level of significance=1.96 (when ?=0.2)

Z_? = Z-value (one tail) at 80% power = 0.85 (when ? = 0.2)

0.8(1 – 0.8) + 0.6(1 – 0.6)

Therefore, n = ———————————– × (1.96 + 0.85)² = 78.96

(0.8 – 0.6)²

So, a total of at least 79 patients were to recruited. But due time constraint, we recruited 50 patients.

3.6 Sampling Technique

Convenient sampling was applied to collect sample from study population.

3.7 Inclusion Criteria

Patients with primary varicocele having

1. Scrotal pain and/or

2. Abnormal semen quality

3.8 Exclusion Criteria:

1. Patients with secondary varicocele

2. Patients with recurrent/persistent varicocele

3. Patients with bilateral varicocele

4. Patients refused to participate.

3.9 Grouping of Sample

All patients were counseled about techniques of varicocele surgery and possibility of using one of them. Patients were divided in two groups alternatively in group A and group B. Patients in group B were treated with Laparoscopic varicocelectomy and group A with inguinal varicocelectomy.

3.10 Outcome Variables

1. Scrotal pain

2. Semen quality

3. Persistence/recurrence of varicocele

4. Hydrocele after surgery

5. Operation time

3.11 Methods

The diagnosis of varicocele was made using patient’s complaint; physical examination and scrotal ultrasonography with Doppler assistance. The varicoceles were assigned a grade by physical examination in standing position. Preoperative pain score was measured. Two preoperative semen analyses from each patient were performed from those who were able to collect semen to have a baseline finding. Semen analysis was evaluated for concentration of spermatozoa, percentage of normal morphology and percentage of spermatozoa showing progressive linear motility.

3.11.1 Varicocelectomy Technique

Laparoscopic Varicocelectomy:

After placement of urethral catheter and nasogastric tube, patient was secured in supine position and was under general anesthesia. A 10-mm trocar was introduced into peritoneal cavity through umbilical port. Then, the abdomen was inflated with carbon dioxide gas (15 mm Hg), and a 10-mm telescope was inserted through the 10-mm trocar. Under direct vision, 2nd and the 3rd trocars (both 5-mm) were bilaterally introduced

a. Varicocele veins identified b.Varicocele veins ligated with metal clips

Figures 2: Laparoscopic varicocelectomy

through the incisions located in the two-third internal distance from the umbilicus to the anterior superior iliac spine. Grasping with one hand using scissors in other hand, two perpendicular incisions are made in the peritoneum overlying the left or right internal spermatic veins. By lifting the vascular mass, arterial and lymphatic component should be separated from the vein(s), clipping of the spermatic veins at the site of the internal inguinal ring was done…Always attempt was made to preserve the testicular artery or lymphatics.

Inguinal varicocelectomy:

Inguinal ligation was performed through a small incision over the inguinal canal that follows the skin lines. The inguinal canal was opened through the external inguinal ring along the direction of the fascial fibers to gain access to the cord just below the internal ring. The cord is isolated over a Penrose drain, excluding the ilioinguinal nerve, and is delivered into the wound. Spermatic fascia was incised and contents of cord were explored.

Figure 3: a) Incision for an inguinal approach to varicocele repair.

b) Level of spermatic vein ligation according to different techniques

The testicular artery was identified and preserved. The veins of the cord, except those associated with the vas, are doubly ligated and divided. Checking for inguinal branches under the spermatic cord was done, but no attempt was made to deliver the testis into the wound to search for gubernacular veins.

3.11.2 Follow-up

All patients were asked to return for follow-up visit at 3 months and 6 months after surgery. Follow up evaluation included a physical examination and ultrasonography to detect recurrence of varicocele or hydrocele formation, assessment of scrotal pain and semen analysis.

3.11.3 Evaluation

This hospital based interventional study was conducted to evaluate and compare the outcome of varicocelectomy by laparoscopic and inguinal approach. At first patients were selected for the study according to selection criteria. The patients were counseled about the advantages and disadvantages of each technique. Then patients were divided in group A and group B. Outcome was evaluated with operation time, improvement of pain score and semen parameter, frequency of recurrence/persistence of varicocele and formation of hydrocele after surgery. To measure the efficacy of a procedure preoperative pain score and semen parameter were compared with postoperative symptom score and semen parameter within group, and frequency of recurrence of varicocele and hydrocele was recorded. Finally, all parameters were compared between two groups to measure the superiority of one procedure to another.

3.12 Ethical Considerations

Semen analysis was not possible in all patients. Semen analysis was avoided in adolescent patients who were unable to collect semen. Collection of semen in those cases was impractical and might cause psychological trauma. Each patient was counseled about the nature of the disease and possible harm if left untreated. Patient was also counseled about advantage and disadvantage of treatment alternatives, and possible complication of surgery. They were assured about management of complication in any. Written consent was taken to participate in the study with freedom of withdrawal at any time. Confidentiality of subject was maintained. Permission from the ethical committee of Dhaka Medical College was taken.

3.13 Data Collection Method

Data was collected by interviewing the patient and evaluating the relevant investigations before surgery and subsequent two visits. A data collection sheet was filled up during each visit. Data collection form (Appendix -II) included particulars of the patients along with varicocele side, grade, duration and severity of pain, semen analysis report, USG. Finding, procedure performed. Data collected by other urologists that fulfill the criteria were included in this study.

3.14 Data Analysis

After meticulous checking and editing, data were compiled and statistical analysis- mean, measures of dispersion (standard deviation) and the tests of significance ( t- test and Chi-square, c² Test) were done using computer, based on statistical software (SPSS version 13) and necessary help was taken from the resource personnel in the field of biostatistics. A p’ value <0.05 was considered as significant.

3.15 Study Design:

Selection of study population

History Physical exam

& Baseline Investigations

Potential Participants Non-participants (by exclusion criteria)

Invitation to participation

and consent

Participants Non participants

Laparoscopic Varicocelectomy (Group-B) Inguinal Varicocelectomy (Group-A)

Post-operative Follow up Post-operative Follow up

Comparison of short term outcome between two groups

3.16 Operational Definitions

Scrotal pain measurement

Varicocele induced scrotal pain was measured with visual analogue scale (appendix I). VAS is a 10 cm long drawing graduated from 0 to 10, where 0 indicates no pain and 10 severe pain. Patient was asked to put a mark on the scale, which best represent, his pain intensity. Pain score was graded as mild (score 0- 3), moderate (score 4- 6) and severe (score 7-10).

Abnormal semen quality

Semen quality was considered abnormal when semen analysis showed sperm concentration less than 20 million/ml, motile sperm less than 50% and normal (oval form) morphology less than 50% of sperm.

Persistence/recurrence ofvaricocele

Failure to resolute or reappearance ofvaricocele after surgery.

Hydrocele after surgery

Clinically detectable fluid collection in the tunica vaginalis and confirmed by ultrasonography.

Operative time

The operative time was calculated from trocar insertion to trocar extraction and skin closure for laparoscopic varicocelectomy,and from incision to skin closure in open varicocelectomy

4.1

4. RESULTS

4.2 Marital status:

Majorities of the study subjects in Group-A (96%) and Group-B (92%) were married (Fig. 1)

Fig.4: Comparison of marital status between groups

4.3Occupation:

Occupation of the patients shows that Businessman was predominant in Group-A, while 36% were service-holder in Group-B. The distribution of other occupations is illustrated in Fig. 2.

Fig.5: Comparison of occupation between groups

4.4 Socioeconomic status:

More than three-quarters (76%) of the patients in Group-A were below average in terms of socioeconomic status as opposed to 40% in Group-B (p = 0.010).

Table II. Comparison of socioeconomic status between two groups

Socioeconomic status	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
Below average	19(76.0)	10(40.0)	0.010
Average	6(24.0)	15(60.0)

Figures in the parentheses denote corresponding percentage

# Chi-square (c²) Test was employed to analyse the data.

4.5 Clinical presentation:

Majority of the patients in both group (76% in Group-A and 68% in Group-B) had varicocel for 3 – 4 years (p = 0.412). Left-sided varicocel was slightly higher than the right-sided (p = 0.984). 100% of patients in Group-A and 80% in Group-B complained of pain (p = 0.037). In terms of intensity of pain over one-third (36%) of Group-A had moderate pain as compared to19% of Group-B(0.203). There was difference between the groups with respect to grade of the varicocele with grade-II forming the main bulk in either group (60% in Group-A and 56% in Group-B) (p = 0.353) (Table III).

Table III. Comparison of clinical presentation between two groups

Clinical presentation	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
Duration of varicocele (yrs) 1 – 2 3 – 4	6(24.0) 19(76.0)	8(32.0) 17(68.0)	0.412
Side involved Right Left	11(44.0) 14(56.0)	11(44.0) 14(56.0)	0.984
Pain Intensity of pain	25(100.0)	21(84.0)	0.037
Mild Moderate	16(64.0) 9(36.0)	17(81.0) 4(19.0)	0.203
Grade of swelling Grade-I Grade-II Grade-III	2(8.0) 17(60.0) 8(32.0)	1(4.0) 14(56.0) 10(40.0)	0.353

Figures in the parentheses denote corresponding percentage

# Chi-square (c²) Test was employed to analyse the data.

4.6 Semen analysis at baseline:

Sperm count was almost similar between Group-A and Group-B (24.0 ± 8.0 vs. 26.3 ± 7.8 million/ml, p = 0.314). However, the sperm motility was significantly better in the latter group than that in the former group (p = 0.002). A few (4% in Group-A and 8% in Group-B) exhibited abnormal morphology (p=0.552) (Table IV).

Table IV. Comparison of semen analysis between two groups

Semen analysis at baseline	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
Sperm count (million/ml)# Sperm motility (%)# Sperm morphology (abnormal)*	24.0 ± 8.0 44.7 ± 9.9 1(4.0)	26.3 ± 7.8 52.6 ± 6.9 2(8.0)	0.314 0.002 0.552

# Student’s t Test was employed to analyse the data.

* Chi-square (c²) Test was employed to analyse the data.

4.7 Duration of operation:

The time required to complete the operation in Group-A and Group-B is shown in Table V. The mean time for operation was significantly lower in Group-A than that in Group-B (p < 0.001).

Table V. Comparison of operative time between two groups

Duration (min)	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
30 – 35	20(80.0)	00
36 – 40	5(20.0)	14(56.0)
41 – 45	00	11(44.0)
Mean ± SD	33.4 ± 2.2	40.5 ± 2.2	< 0.001

# Student’s t Test was employed to analyse the data.

4.8 Outcome at different follow up:

At 1^st follow up visit, the complaints of pain was drastically reduced in both groups (24% in Group-A and 8% in Group-B, p = 0.123) and all of them had mild pain only . Around 24% in Group-A and 2% in group-B exhibited scrotal swelling (p = 0.347). At 2^nd follow up,pain and scrotal oedema absent in all patients in both group (table VI).

Table VI. Comparison of outcome of follow up between two groups

Outcome	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
At 1st follow up
Pain	6(24.0)	2(8.0)	0.123
Intensity of pain Mild	6(100.0)	2(100.0)	–
Scrotal oedema	6(24.0)	2(8.0)	0.347
At 2nd follow up
Pain	00	00	–
Scrotal oedema	00	00	–

* Chi-square (c²) Test was employed to analyse the data.

4.9 Semen analysis:

The findings of semen analysis at 1^st and 2^nd follow up visits are depicted in table VII. Analyses show that there was negligible improvement in semen quality in terms of sperm count, motility and morphology from there baseline figures. However, sperm count and motility were considerably better in the latter group (p = 0.002).

Table VII. Comparison of semen analysis between two groups

Semen analysis	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
At 1st follow up Sperm count (million/ml) # Sperm motility (%)# Sperm morphology (abnormal)*	25.0 ± 6.3 47.9 ± 8.9 1(4.0)	28.1 ± 8.1 55.9 ± 6.9 5(20.0)	0.137 0.001 0.082
At 2nd follow up Sperm count (million/ml) # Sperm motility (%)# Sperm morphology (abnormal)*	26.1 ± 6.5 49.7 ± 8.3 2(8.0)	28.3 ± 8.0 56.8 ± 7.2 2(8.0)	0.295 0.002 0.695

# Student’s t Test was employed to analyse the data.

* Chi-square (c²) Test was employed to analyse the data

4.10 Complications at different follow up:

The Group-A neither developed hydrocele nor testicular atrophy, where as 20% and 12% of cases of Group-B developed hydrocele and testicular atrophy respectively (p = 0.025 and p = 0.117 respectively). The recurrence rate of varicocele was a lower in the former group than that in the latter group (p = 0.049).

Table VIII. Comparison of complication at different follow up between groups

Complications	Group		p-value
	Group-A (n = 25)	Group-B (n = 25)
At 1st follow up
Hydrocele	00	5(20.0)	0.025
Recurrence of varicocele	1(4.0)	6(24.0)	0.049
Testicular atrophy	00	3(12.0)	0.117
At 2nd follow up
Hydrocele	00	5(20.0)	0.025
Recurrence of varicocele	1(4.0)	6(24.0)	0.049
Testicular atrophy	00	3(12.0)	0.117

Figures in the parentheses denote corresponding percentage.

* Chi-square (c²) Test was employed to analyse the data.

4.11 Hospital stay:

The average duration of hospital stay was significantly higher in Group-A than that in Group-B (5.4 ± 1.0 vs. 2.6 ± 0.7 days, p < 0.001) (Table VIII).

Table IX. Comparison of hospital stay between two groups

Duration (days)	Group		p-value
	Case (n = 25)	Control (n = 25)
2 – 4	5(20.0)	25(100.0)
5 – 7	20(80.0)	00
Mean ± SD	5.4 ± 1.0	2.6 ± 0.7	<0.001

# Student’s t Test was employed to analyse the data.

5. Discussion

Varicocele is the one of the most common cause of male infertility and in up to 40% cases evaluated of subfertility levels (Budair 2003). There are different surgical methods for varicocele treatment likely open inguinal method, Palomo method, laparoscopic method and sclerotherapy. However, the most effective and least invasive methods in terms of outcome and post operative complication, is still not determined. Present study was designed to evaluate and compare the outcome of mostly practiced procedure for varicocele in our context in the form of inguinal approach and laparoscopic approach. For evaluation of outcome, operation time, resolution of scrotal pain, improvement of semen parameters, recurrence or persistence of varicocele, and formation of postoperative hydrocele was assessed and compared between laparoscopic ligation and inguinal approach.

The present study included a total of 50 cases of varicocele of different grades and were assigned to open varicocelectomy (Group-A, n = 25) and laparoscopic varicocelectomy (Group-B, n=25).The mean ages of the patients of Group-A and Group-B 29.1 ± 2.0 years and 28.9 ± 1.5 years respectively. Majorities of the study subjects in Group-A (96%) and Group-B (92%) were married.76% of the patients of open varicocelectomy were below average in terms of socioeconomic status as opposed to 40% in laparoscopic group. There is no significant differences of mean ages between two groups (p=0.643) but socioeconomic status is significantly difference in two group (p=0.010). The age distribution of the patients and grade of varicocele was comparable with previous study of Steeno et al. 1976 and Skoog et al. 1997.

Varicocele is more common on left side (approximately 80-90%) because of several anatomical factors, including the angle at which the left testicular vein enters the left renal vein, the lack of effective antireflux valves at the junction of testicular vein and renal vein. In this study, left-sided varicocel was slightly higher than the right-sided (p = 0.984).

The affect of varicocele grade on the magnitude of improvement in semen quality after varicocelectomy has been equivocal. Steckel et al. (1993) reported that men with larger varicocele presented with lower sperm densities and had greater relative improvement in semen quality than men with smaller varicocele who presented with a greater mean sperm concentration. In contrast, Braedel et al. (1994) demonstrated less of an improvement in sperm concentration in men with grade III varicocele than in men with smaller varicocele. This study shows Grade-II varicocele forming the main bulk in either group (60% in Group-A and 56% in Group-B), no significant difference (p=0.353) in sperm count and morphology between grade. Mminimum improvement in semen quality observed between those with grade II and grade III varicocele postoperatively.

In the present study, 100% patients in Group-A and 84% in Group-B complained of pain preoperatively, in terms of intensity of pain, over one-third (36%) of Group-A had moderate pain as compared to19% of Group-B (p=0.203). Postoperatively the complaints of pain was drastically reduced in both groups and all of them had mild pain only (24% in Group-A and 8% in Group-B, p = 0.123). These finding were comparable with the finding of a retrospective review of 35 patients by Peterson et al. (1998) undergoing different ligation techniques for painful varicocele. The complete resolution rate in their study was reported as 86%. But another retrospective study (Diggers and Soderdahl, 1981) showed pain control in 48% of patients. This difference may be due to use of high ligation technique only. In inguinal ligation cremasteric veins can also be ligated. This may contribute to higher success rate in other study.

The mean operative time was significantly lower for inginal approach compared with laparoscopic varicocelectomy (p<0.001). Shamsa et al. (2009) reported mean operative time 30.0 ± 5.5 minutes for laparoscopies, 27.0 ±3.5 minutes for open inguinal varicocelectomy under general anesthesia, and 38.0 ± 1.8 minutes for open varicocelectomy under local anesthesia in a comparative study of 30 each cases in above procedures. Ogura et al. (1994) performed bilateral laparoscopic varicocelectomy on 39 patients with an operative time of 96.6 minutes. The possible causes for more time are general anesthesia, nasogastric tube suction, Foley catheterization, learning curve which are required for laparoscopy.

In this study, 6(24%) patients in group –A and 2(8%) patients in group-B develop scrotal oedema postoperatively, may be due to haematoma. These were treated by rest, nonsteroid anti inflammatory drugs and scrotal supports and relieved within 2^nd followup.

The result of present study showed there was negligible improvement in semen quality in terms of sperm count, motility and morphology from there baseline figures. However, sperm count and motility were considerably better