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Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy (CMMV)

Primary Purpose

Varicocele

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Combined Microscopic Varicocelectomy
Inguinal and Subinguinal varicocelectomy
Sponsored by
Omid Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicocele focused on measuring varicocele, varicocelectomy, complications of varicocelectomy, Recurrence of varicocele, Post-varicocelectomy testicular atrophy, Post-varicocelectomy hydrocele

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Complexity and tortuosity of the veins at inguinal level so that separating and ligation of the vein could lead to artery injury
  • Veins which are contiguous with arteries so that separating and ligation of the vein could lead to artery injury

Exclusion Criteria:

  • Prior surgery at inguinal level such as Herniorrhaphy, Orchiopexy,etc.

Sites / Locations

  • Omid fertility center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined Microscopic Varicocelectomy

Inguinal and Subinguinal Varicocelectomy

Arm Description

Patients in this arm were operated with Combined Mini-incision Microscopic approach

Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associates

Outcomes

Primary Outcome Measures

Recurrent Varicocele
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery

Secondary Outcome Measures

Post-varicocelectomy Hydrocele
Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery

Full Information

First Posted
March 18, 2014
Last Updated
June 7, 2015
Sponsor
Omid Fertility Center
Collaborators
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02092311
Brief Title
Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy
Acronym
CMMV
Official Title
Assessing Post-operative Rates of Recurrence, Hydrocele and Testicular Atrophy in Patients Operated With a New Approach of Varicocelectomy Named Combined Mini-incision Microscopic Varicocelectomy (CMMV)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omid Fertility Center
Collaborators
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the rates of major post-varicocelectomy complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is that using this method will lead to less major complications of recurrence, hydrocele, and also less incidental injuries to the arteries that will result less testicular atrophy
Detailed Description
The sample is selected from the patients who were referred to our center for surgical treatment of varicocele. Most of them were diagnosed after being evaluated for infertility. All of them were operated by a single experienced and expert microscopic surgeon. Informed consent is received from all of the possible candidates in accordance to national and Declaration of Helsinki guidelines. Selection of patients for undergoing Combined varicocelectomy was done during the operation due to the nature of including criteria. In this method after making an incision at inguinal level, veins are evaluated and if the including criteria is existed, only external spermatic vein is ligated at the depth of the inguinal canal and other veins are left alone for prevention of damage to the artery. Then another mini incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach. The incidence rate of major complications (recurrence, testicular atrophy, hydrocele) of experimental group is compared to the incidence rate of the same complications of the patients in control group that were operated with currently common inguinal and subinguinal microscopic varicocelectomy accompanied by testicular delivery, an approach that is suggested by Goldstein and associates. The study hypothesis is that using this method will lead to less major complications including recurrence, hydrocele and also less incidental injuries to the arteries that will result to less testicular atrophy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele
Keywords
varicocele, varicocelectomy, complications of varicocelectomy, Recurrence of varicocele, Post-varicocelectomy testicular atrophy, Post-varicocelectomy hydrocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Microscopic Varicocelectomy
Arm Type
Experimental
Arm Description
Patients in this arm were operated with Combined Mini-incision Microscopic approach
Arm Title
Inguinal and Subinguinal Varicocelectomy
Arm Type
Active Comparator
Arm Description
Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associates
Intervention Type
Procedure
Intervention Name(s)
Combined Microscopic Varicocelectomy
Intervention Description
After making a mini-incision at inguinal level, veins are evaluated, and if the including criteria (Complexity and tortuosity of the veins and/or existence of veins that are contiguous with arteries so that separating and ligation of the veins could jeopardize the artery) are existed, only external spermatic vein, if dilated, is ligated at the depth of the inguinal canal, and other veins are left alone for prevention of damage to the artery. Subsequently, another mini-incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach, which is also done microscopically
Intervention Type
Procedure
Intervention Name(s)
Inguinal and Subinguinal varicocelectomy
Intervention Description
Microscopic Inguinal and Sub inguinal varicocelectomy, recommended by Goldstein and associates, are currently popular approaches. In this approach the spermatic cord structures are pulled up and out of the wound so that the testicular artery, lymphatics, and small periarterial veins may be more easily identified. In addition, an inguinal or subinguinal approach allows access to external spermatic and even gubernacular veins.
Primary Outcome Measure Information:
Title
Recurrent Varicocele
Description
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post-varicocelectomy Hydrocele
Description
Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery
Time Frame
6months
Other Pre-specified Outcome Measures:
Title
Post-varicocelectomy Testicular Atrophy
Description
development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery
Time Frame
6months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complexity and tortuosity of the veins at inguinal level so that separating and ligation of the vein could lead to artery injury Veins which are contiguous with arteries so that separating and ligation of the vein could lead to artery injury Exclusion Criteria: Prior surgery at inguinal level such as Herniorrhaphy, Orchiopexy,etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omid Pouyan, MD
Organizational Affiliation
Omid Fertility Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Navid Pooyan, MD
Organizational Affiliation
Omid Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robabeh Taheri Panah, MD
Organizational Affiliation
Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ashraf Ale Yasin, MD
Organizational Affiliation
Omid Fertility Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marzieh Agha Hosseini, MD
Organizational Affiliation
Omid Fertility Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hojatollah Saeidi Saeid Abadi, P.H.D
Organizational Affiliation
Omid FC
Official's Role
Study Chair
Facility Information:
Facility Name
Omid fertility center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy

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