International Journal of Surgery 18 (2015) 178e183

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Original research

Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study Tamer Youssef*, Emad Abdalla Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt

h i g h l i g h t s  Single incision laparoscopic varicocelectomy (SILS-V) has been reported to be safe and effective.  This is the first prospective randomized study evaluating SIL-V in patients with bilateral varicocele and through a transumbilical incision.  The results of this study may remove any inhibitions that exist about the use of SIL-V in treatment of patients with varicocele.

a r t i c l e i n f o

a b s t r a c t

Article history: Received 12 February 2015 Received in revised form 11 April 2015 Accepted 20 April 2015 Available online 1 May 2015

Background: Varicocele is the most common correctable cause of infertility. We analyzed the outcomes of single incision laparoscopic varicocelectomy (SIL-V) in comparison with conventional transperitoneal varicocelectomy (CTL-V). Methods: Patients with clinically palpable varicocele treated by laparoscopic varicocelectomy were randomly allocated into two groups: SIL-V and CTL-V group. The primary outcome measures were improvement in semen parameters and resolution of testicular pain. Secondary outcome measures included operating time, postoperative pain scores, time to return to normal activity, patient satisfaction and postoperative complications. Results: Eighty patients completed the study. No vascular or intestinal complications occurred during both procedures. All patients were discharged 24 h postoperatively. The parameters measuring the success of varicocelectomy had improved for the majority of patients with no significant difference between the two groups. There was significantly longer operating time in SIL-V group (44.6 ± 5.4 min) than in CTL-V group (41.3 ± 8.5 min) (P ¼ 0.03). The difference in operating time was lost when bilateral procedures were compared (P ¼ 0.21). The mean VAS scores for pain at 3, 24 and 48 h postoperatively were significantly lower in SIL-V group (P ¼ 0.02, P ¼ 0.03 and P < 0.001 respectively). Time to return to normal activity was significantly shorter in SIL-V (P < 0.001). Patient satisfaction was significantly higher in SIL-V group (P < 0.01). Postoperative complications were comparable in both groups. Conclusion: SIL-V is a safe and effective straightforward alternative to the well-established and accepted CTL-V. The tendency toward decreased postoperative pain, rapid return to normal activity and the high patients' satisfaction rate regarding cosmetic results are potential benefits of SIL-V procedure. Clinical trial: (NCT02335385). © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Keywords: Varicocele Infertility Varicocelectomy Single incision laparoscopic varicocelectomy

1. Introduction Varicocele, a collection of abnormally dilated tortuous spermatic veins, is the most common correctable cause of infertility [1].

* Corresponding author. Mansoura University Hospital, Gomhoria St., Mansoura, Egypt. E-mail address: [email protected] (T. Youssef).

It is estimated that over 13.4% of all adult males, 37% of infertile men [2], and 81% of men with secondary infertility have varicocele [3]. Varicocele repair is clearly associated with a significant improvement in semen parameters, including sperm concentration, total and progressive motility as well as sperm ultramorphology [1]. Although there are different options (eg. Percutaneous sclerosis, laparoscopy, retroperitoneoscopy, open

http://dx.doi.org/10.1016/j.ijsu.2015.04.048 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

T. Youssef, E. Abdalla / International Journal of Surgery 18 (2015) 178e183

surgery) for treatment of varicoceles, there is not currently a gold standard for its treatment [4]. Recent studies showed that the laparoscopic varicocelectomy approach is rapid, safe, effective and minimally invasive option for treatment of varicocele [5,6]. However, microsurgical varicocelectomy is considered by some authors to combine favorable outcomes with a low incidence of recurrence and hydrocele formation [1,7]. Other authors criticize the technique for its longer operating times when compared to the laparoscopic approach as there is no difference in long term complications between the two techniques [8,9]. Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds. Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmetic outcomes, reduced postoperative pain, and rapid return to normal activities [10,11]. SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies [12e14]. The aim of the present prospective randomized study was to evaluate the safety and efficacy of single incision laparoscopic varicocelectomy (SIL-V) and compare it with the conventional transperitoneal laparoscopic varicocelectomy (CTL-V) regarding patient outcomes. 1.1. Patients and methods This prospective randomized study was conducted at Surgery Departments of Mansoura University Hospitals in Egypt. The study group included patients with clinically palpable varicocele who underwent laparoscopic varicocelectomy during the period from June 2010 to June 2012. The study was approved by the local ethical committee and registered at the clinical trials registry of the National Institute of Health (NCT02335385). Written informed consent was obtained from all patients included in the study after detailed explanation of the purpose of the study. Patients with recurrent varicoceles and those participating in other trials were excluded. The indications of surgery were infertility or chronic testicular pain. Varicoceles were diagnosed by clinical scrotal examination and confirmed by scrotal ultrasound with real time color Doppler imaging. When bilateral varicocele was diagnosed, the larger size was reported. Patients age, BMI, ASA score, varicocele side, varicocele grade, semen parameters were recorded preoperatively. Patients were randomized into two groups according to the varicocelectomy technique: SIL-V group and CTL-V group. Randomization was simple and achieved using sealed envelopes.

Fig. 1. A transumilical transverse skin incision.

port were introduced through the access channels of the SILS port, a pneumoperitoneum was created and maintained at 15 mmHg. A 10-mm telescope was inserted through it. The patient was then placed in the modified Trendelenburg position (15-degree incline). Roticulator Endo Grasper 5-mm (Autosuture) and a straight laparoscopic scissors were inserted through the 5-mm working ports (Fig. 3). A perpendicular incision into the peritoneum overlying the left internal spermatic veins was made after division of the peritoneal adhesions between the intestine and/or mesentry and the retroperitoneum. The peritoneal wound window was enlarged to obtain sufficient exposure to the testicular vessels. The vascular mass was lifted to separate the arterial and lymphatic components from the veins. One of the 5-mm canulae was replaced by 10-mm one, through which a 10-mm clip applier was introduced and the veins were clipped. The same was done over the right spermatic veins in bilateral cases. At the end of the procedure, the 3 canulae and SILS port were removed and the fascia was closed followed by the umbilical skin (Fig. 4).

1.2. SIL-V group All were subjected to single incision laparoscopic varicocelectomy. Each patient was placed in a supine low lithotomy position under general anesthesia. A transverse 2 cm skin incision was made through the umbilicus (transumilically) (Fig. 1). The underlying fascia was incised vertically with placement of 2 stay sutures at the edges. Once the preperitonesl fat was identified, a blunt artery forceps was introduced into the peritoneal cavity under direct vision. Next, the flexible SILS port (Covidien) (Fig. 2) was folded at its lower edge contralateral to the insufflation system with the use of a small artery forceps and was advanced under direct vision into the abdomen. Once the bottom half of the port was inside the abdomen, the port was released from the artery forceps. After the three cannulae (one 10-mm and two 5-mm) provided with the SILS

179

Fig. 2. Flexible SILS port (Covidien).

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Fig. 3. Roticulator Endo Grasper 5-mm (Autosuture) and a straight laparoscopic scissors were inserted through the 5-mm working ports.

1.3. CTL-V group All were subjected to conventional transperitoneal laparoscopic varicocelectomy. Each patient was placed in a supine low lithotomy position under general anesthesia. Veress needle was introduced through the umbilicus with CO2 gas inflation until an intraperitoneal pressure of 15 mmHg is reached. Then a 1-cm transverse midline incision was made immediately below the umbilicus. A 10mm trocar was introduced into the peritoneal cavity and a 10-mm telescope was inserted through it. The patient was then placed in the modified Trendelenburg position (15-degree incline). Under direct vision, the 2nd and the 3rd trocars (10-mm and 5-mm) were bilaterally introduced through the incisions located in the twothird internal distance from the umbilicus to the anterior superior iliac spine. A straight laparoscopic grasper and a scissor were used to put a perpendicular incision into the peritoneum overlying the internal spermatic veins. The same steps were done as in SIL-V. At the end of the procedure, the 3 skin incisions were closed. The primary outcome measures were improvement in semen parameters and resolution of testicular pain. Secondary outcome measures included operating time, postoperative pain scores, time to return to normal activity, patient satisfaction and postoperative complications. Two surgeons experienced in laparoscopic surgery performed both procedures in a comparable ratio. Operating time was calculated from trocar insertion to trocar extraction and skin closure. Postoperative analgesia was the same for both groups; routine administration of tramadol hydrochloride and ketorlac tromethamine, with tramadol hydrochloride used to provide additional analgesia on request. Postoperative pain was assessed at

Fig. 4. Umbilical incision after closure.

postoperative hours 3, 24 and 48 using visual analogue scale (VAS) pain scores that ranged from 0 (no pain) to 10 (worst pain). Patients were instructed to complete the rest of VAS forms at home and bring it back during follow up at day 7. Patients were followed up at 1st and 2nd postoperative weeks and then every 3 months afterwards. Postoperative semen analyses were obtained starting at 3 months after surgery. The most improved postoperative semen analysis was used for data analysis. Similarly resolution of testicular pain was assessed at 3 months postoperatively. Time to return to normal activity was calculated by the time needed to carry on usual daily activities with pain. Patient satisfaction regarding cosmetic outcome was assessed at 3 months postoperatively by asking the patients to rate their level of satisfaction as very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. Patients were considered satisfied if they reported being very or somewhat satisfied. Postoperative complications involved in both procedures were observed during clinical and instrumental examination performed at the scheduled follow up visits. Persistence of varicocele was considered if there was a presence of venous reflux 1 day after surgery, while recurrence was considered if there was a presence of venous reflux 3 months after surgery. Venous reflux in the spermatic cord, with or without Valsalva maneuver was considered pathologic. Unless stated otherwise, all data are expressed as mean ± standard deviation (SD) or as percentages. Descriptive and inferential statistical analyses were performed using both parametric and nonparametric procedures as appropriate. Comparisons of categorical/ordinal variables were performed using chi-square analysis for trends. Continuous variables were compared using an independent group test. Criterion for statistical significance was set at P < 0.05. 2. Results The study flow chart is shown in Fig. 5. Of the 104 patients with clinically palpable varicocele seen during the study period, 93 patients were eligible and included in the study. Thirteen patients were lost during follow up period and were excluded from further analysis in the study (7 patients were elected to follow up with their local doctors, 4 patients had travelled abroad and 2 patients had incorrect phone numbers). Finally, the analyzed patients were 41 in SIL-V group and 39 in CTL-V group. Patients were followed for 13 ± 2.2 and 12.9 ± 1.8 months in SIL-V and CTL-V group respectively (P ¼ 0.82). Demographic data are shown in Table 1. The age, BMI, ASA score, varicocele side, varicocele grade and indications of surgery were comparable in both groups. There were 37 and 34 patients with abnormal semen parameters in SIL-V and CTL-V groups respectively. No vascular or intestinal complications occurred while trocar introduction. No conversion from SIL-V to CTL-V was necessary due to mechanical limitations. Similarly, no conversion to open approach was necessary in both procedures. All patients were discharged 24 h following the operation. There was significantly longer operating time in SIL-V group (44.6 ± 5.4 min) than in CTL-V group (41.3 ± 8.5 min) (P ¼ 0.03). The difference in operating time was lost when bilateral procedures were compared in both groups (P ¼ 0.21). There was no significant difference regarding the use of additional analgesia, which was requested by 17.1% of patients in SIL-V group and 17.9% of patents on CTL-V group. The mean VAS scores for pain at 3, 24 and 48 h postoperatively were significantly lower in SIL-V group compared to CTLV group at the three time points (P ¼ 0.02, P ¼ 0.03 and P < 0.001 respectively). Time to return to normal activity was significantly shorter in SIL-V group than in CTL-V group (P < 0.001) (Table 2).

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Fig. 5. Flow diagram of the progress through the phases of a randomized trial (i.e. enrollment, intervention allocation, follow up and data analysis).

The parameters measuring the success of varicocelectomy (i.e. sperm parameters and testicular pain) had improved for the majority of patients with no significant difference between the 2 groups (Table 2). Semen parameters were improved in 75.7% and in 73.5% of patients in SIL-V and in CTL-V groups respectively while 83.3% and 87.5% of patients in SIL-V and CTL-V groups respectively reported resolution of testicular pain. Comparison between mean preoperative and postoperative semen parameters showed significant improvement in sperm concentration, motility, and morphology in both groups with no significant difference between the 2 groups regarding this improvement (Table 3). Postoperative complications were comparable in both groups as shown in Table 2. Recurrence of left-sided varicocele occurred in 2 patients (one from each group) which were managed by open varicocelectomy. Unilateral hydrocele developed in 2(6.1%) and 1(3.2%) patients in SIL-V group and CTL-V group respectively. The

three patients required reoperation for subtotal excision of tunica vaginalis. Three patients suffered wound infections which were managed conservatively. One patent in SIL-V group developed scrotal edema and was managed by nonsteroidal antiinflammatory drugs and scrotal elevator. Surgical abdominal wall emphysema with shoulder pain occurred in one patient of the CTLV group and was managed by nonsteroidal anti-inflammatory drugs. No port-site hernias developed after both procedures. There was a significant difference in patient satisfaction distribution regarding the cosmetic outcome between both groups with the SIL-V group (P < 0.01) reporting a greater satisfaction (Fig. 6). In SIL-V group 37 (90.2%) patients were very satisfied and 4(9.8%) were somewhat satisfied with no patients reporting being somewhat or very dissatisfied. In CTL-V group, 23(58.9%), 13(33.3%), 2(5.2%) and 1(2.6%) patients were very satisfied, somewhat satisfied, somewhat dissatisfied or very dissatisfied respectively.

Table 1 Patients demographics.

3. Discussion

Variables Age (years) (mean ¼ SD) BMI (mean ± SD) ASA score ASA PS 1 ASA PS 2 ASA PS 3 Varicoceles (n) Varicocele side Unilateral Bilateral Varicocele grade Grade II Grade III Indication for surgery Infertiliy Testicular pain

SIL-V (n ¼ 41)

CTL-V (n ¼ 39)

P value

26 ± 4.2 (20e37)

26.5 ± 4.3 (19e36)

NS

24.4 ± 3.7

24.1 ± 4.2

NS

20 19 2 76

21 17 1 60

6 35

8 31

19 22

18 21

35 6

31 8

NS

NS

NS

NS

The first successful applications of modern laparoscopic surgery were only 25 years ago [15]. Recent meta-analysis and literature reviews showed that outcomes are comparable between laparoscopic varicocelectomy and other surgical varicocelectomy procedures [6]. The clear magnified surgical field provided by the laparoscopy allows more accurate identification of vessels with subsequent minimization of recurrence, hydrocele formation and testicular atrophy [16]. The classic laparoscopic surgery utilizes multiple incisions related to portals which have been associated with postoperative pain, wound infection (1.3%e9%) and incisional hernia (0.77%e3%) [17,18]. The intention to produce a better aesthetic result, with low morbidity and only one site of pain and potential infection precipitated the advent of single incision laparoscopic surgery (SILS) or laparoendoscopic single site surgery (LESS). SILS procedure represents a junction between a natural surgical access route, the skin and a natural orifice or scar (the umbilicus) [19].

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Table 2 Operative and postoperative outcomes. Variables

SIL e V

CTL-V

P value

Operating time: (minutes) Unilateral Bilateral Postoperative pain scores At 3 h At 24 h At 48 h Time to return to normal activity Follow-up period (months) Resolution of testicular pain Improvement of semen parameters Postoperative complications 1. Persistence 2. Recurrence 3. Hydrocele 4. Wound infection 5. Epididymitis 6. Surgical emphysema 7. Scrotal edema 8. Port-site hernia

44.6 ± 5.4 (34e62) 37 ± 2.4 (34e40) 46.2 ± 4.6 (40e62)

41.3 ± 8.5 (25e54) 27.7 ± 4.1 (25e35) 44.6 ± 5.8 (33e54)

0.03 0.02 0.21

3.6 ± 1.5 (0e10) 2.8 ± 1.4 (0e8) 1.2 ± 1.1 (0e4) 2.8 ± 0.9 (2e5) 13 ± 2.2 5/6 (83.3%) 28/37 (75.7%)

4.4 ± 1.7 (0e9) 3.6 ± 1.4 (0e7) 2.6 ± 1.7 (0e6) 5.4 ± 1.1 (3e7) 12.9 ± 1.8 7/8 (87.5%) 25/34 (73.5%)

0.02 0.03 0.001 0.001 NS NS NS

0 1 2 1 0 0 1 0

0 1 1 2 0 1 0 0

NS

Table 3 Preoperative and postoperative semen parameters of infertile patients in both groups. Semen parameters

Sperm concentration (million/mL) Sperm motility (%) Normal forms (%)

SIL e V

CTL-V

P value

Preop

Postop

P value

Preop

Postop

P value

21 ± 5 22 ± 2 33 ± 3

40 ± 6 31 ± 2 36 ± 2

Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study.

Varicocele is the most common correctable cause of infertility. We analyzed the outcomes of single incision laparoscopic varicocelectomy (SIL-V) in co...
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