ClinicalTrials.gg
CompletedNCT02335385Updated Jan 9, 2015

Single Incision Laparoscopic Varicocelectomy

An interventional study of single incision laparoscopic varicocelectomy and conventional transperitoneal laparoscopic varicocelectomy in Varicocele, sponsored by Mansoura University. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-09.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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 cosmotic 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.

02

Conditions studied

  • Varicocele

Browse trials for

03

In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's enrollment of 90 is above the median of 72 across 36 interventional studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with palpable varicoceles

Exclusion criteria

Exclusion Criteria:

  • unfit for anesthesia or laparoscopy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    SIL-V

    single incision laparoscopic varicocelectomy

    Procedure: single incision laparoscopic varicocelectomy

  • Active comparator
    CTL-V

    conventional transperitoneal laparoscopic varicocelectomy

    Procedure: conventional transperitoneal laparoscopic varicocelectomy

Interventions

  • Proceduresingle incision laparoscopic varicocelectomy

    bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.

  • Procedureconventional transperitoneal laparoscopic varicocelectomy

    bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy

06

What researchers measure

Primary outcomes

  1. number of patients with improvement in semen parameters and resolution of testicular pain

    Time frame: 2 years

Secondary outcomes

  1. number of patients developing postoperative complications

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Youssef T, Abdalla E. Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study. Int J Surg. 2015 Jun;18:178-83. doi: 10.1016/j.ijsu.2015.04.048. Epub 2015 May 1. Erratum In: Int J Surg. 2015 Aug;20:170. PubMed 25937155 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02335385
Responsible party
Tamer Youssef Mohamed (assistant professor of surgery, Mansoura University) — Principal investigator
First posted
Jan 9, 2015
Start date
Jun 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jan 9, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion