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

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ClinicalTrials.gov Identifier: NCT02092311
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : June 30, 2014
Last Update Posted : July 3, 2015
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Omid Fertility Center

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

Condition or disease Intervention/treatment Phase
Varicocele Procedure: Combined Microscopic Varicocelectomy Procedure: Inguinal and Subinguinal varicocelectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Combined Microscopic Varicocelectomy
Patients in this arm were operated with Combined Mini-incision Microscopic approach
Procedure: Combined Microscopic Varicocelectomy
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

Active Comparator: Inguinal and Subinguinal Varicocelectomy
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
Procedure: Inguinal and Subinguinal varicocelectomy
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 Measures :
  1. Recurrent Varicocele [ Time Frame: 6 months ]
    post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery


Secondary Outcome Measures :
  1. Post-varicocelectomy Hydrocele [ Time Frame: 6months ]
    Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery


Other Outcome Measures:
  1. Post-varicocelectomy Testicular Atrophy [ Time Frame: 6months ]
    development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092311


Locations
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Iran, Islamic Republic of
Omid fertility center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Omid Fertility Center
Shahid Beheshti University of Medical Sciences
Investigators
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Study Director: Omid Pouyan, MD Omid Fertility Center
Principal Investigator: Navid Pooyan, MD Omid Fertility Center
Study Chair: Robabeh Taheri Panah, MD Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences
Study Chair: Ashraf Ale Yasin, MD Omid Fertility Center
Study Chair: Marzieh Agha Hosseini, MD Omid Fertility Center
Study Chair: Hojatollah Saeidi Saeid Abadi, P.H.D Omid FC

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Responsible Party: Omid Fertility Center
ClinicalTrials.gov Identifier: NCT02092311     History of Changes
Other Study ID Numbers: CMMV
First Posted: March 20, 2014    Key Record Dates
Results First Posted: June 30, 2014
Last Update Posted: July 3, 2015
Last Verified: June 2015

Keywords provided by Omid Fertility Center:
varicocele
varicocelectomy
complications of varicocelectomy
Recurrence of varicocele
Post-varicocelectomy testicular atrophy
Post-varicocelectomy hydrocele

Additional relevant MeSH terms:
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Varicocele
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases