Single Incision Laparoscopic Varicocelectomy

NCT ID: NCT02335385

Last Updated: 2015-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Varicocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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SIL-V

single incision laparoscopic varicocelectomy

Group Type ACTIVE_COMPARATOR

single incision laparoscopic varicocelectomy

Intervention Type PROCEDURE

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

CTL-V

conventional transperitoneal laparoscopic varicocelectomy

Group Type ACTIVE_COMPARATOR

conventional transperitoneal laparoscopic varicocelectomy

Intervention Type PROCEDURE

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

Interventions

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single incision laparoscopic varicocelectomy

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

Intervention Type PROCEDURE

conventional transperitoneal laparoscopic varicocelectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with palpable varicoceles

Exclusion Criteria

* unfit for anesthesia or laparoscopy
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Youssef Mohamed

assistant professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 25937155 (View on PubMed)

Other Identifiers

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MFM200912

Identifier Type: -

Identifier Source: org_study_id

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