Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy

February 12, 2024 updated by: Ahmed Zoeir, Tanta University

Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy in Infertile Men With Oligo-asthenzoospermia: A Prospective Randomized Trial.

In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective randomized study, in which adult infertile patients with clinical varicocele and oligo-athenospermia admitted to Urology department Tanta university hospital will be included and then the patients with detected spermatic cord lipoma at the time surgery will be enrolled and divided into 2 groups:

GROUP A : will undergo subinguinal varicocelectomy with excision of spermatic cord lipoma GROUP B : will undergo subinguinal varicocelectomy with preservation of spermatic cord lipoma

Inclusion criteria:

  • Adult infertile males
  • Clinical varicocele
  • oligo-asthenospermia

Exclusion criteria:

  • Adolescent varicocele
  • Recurrent varicocele
  • Presence of inguinal hernia
  • Azospermic patients

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbeya
      • Tanta, Gharbeya, Egypt, 11511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult infertile males
  • Clinical varicocele
  • Semen analysis show oligo-athenospermia

Exclusion Criteria:

  • Adolescent varicocele
  • Recurrent varicocele
  • Presence of inguinal hernia
  • Azospermic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lipoma Excision (group A)
excison of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males
Procedure: subinguinal varicocelectomy
exision or preservation of spermatic cord lipoma during subinguinal varicocelectomy
Active Comparator: Lipoma Preservation (group B)
preservation of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males
Procedure: subinguinal varicocelectomy
exision or preservation of spermatic cord lipoma during subinguinal varicocelectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
semen parameters improvement
Time Frame: 3 and 6 months after surgery
semen analysis
3 and 6 months after surgery
symptoms improvement (pain and swelling)
Time Frame: 3 and 6 months after surgery
improvement of preoperative scrotal pain and swelling was assessed
3 and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: early after surgery and late
post-operative scrotal edema, hematoma and wound infection were assessed
early after surgery and late

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36137/12/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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