Single Incision Laparoscopic Varicocelectomy
Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.
1 other identifier
interventional
90
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2009
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 7, 2015
CompletedFirst Posted
Study publicly available on registry
January 9, 2015
CompletedJanuary 9, 2015
January 1, 2015
3 years
January 7, 2015
January 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
number of patients with improvement in semen parameters and resolution of testicular pain
2 years
Secondary Outcomes (1)
number of patients developing postoperative complications
2 years
Study Arms (2)
SIL-V
ACTIVE COMPARATORsingle incision laparoscopic varicocelectomy
CTL-V
ACTIVE COMPARATORconventional transperitoneal laparoscopic varicocelectomy
Interventions
bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.
bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy
Eligibility Criteria
You may qualify if:
- patients with palpable varicoceles
You may not qualify if:
- unfit for anesthesia or laparoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25937155DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor of surgery
Study Record Dates
First Submitted
January 7, 2015
First Posted
January 9, 2015
Study Start
June 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 9, 2015
Record last verified: 2015-01