Clinical trial NCT02092311: Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy
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
Overall status: COMPLETED
Phase: NA
Conditions: Varicocele
Keywords: varicocele
varicocelectomy
complications of varicocelectomy
Recurrence of varicocele
Post-varicocelectomy testicular atrophy
Post-varicocelectomy hydrocele
Lead sponsor: Omid Fertility Center
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2014-03-20
Enrollment: 570
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recurrent Varicocele
timeFrame: 6 months
Secondary outcomes:
measure: Post-varicocelectomy Hydrocele
timeFrame: 6months
Other outcomes:
measure: Post-varicocelectomy Testicular Atrophy
timeFrame: 6months
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Omid fertility center
Study officials:
affiliation: Omid Fertility Center
name: Omid Pouyan, MD
role: STUDY_DIRECTOR
affiliation: Omid Fertility Center
name: Navid Pooyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences
name: Robabeh Taheri Panah, MD
role: STUDY_CHAIR
affiliation: Omid Fertility Center
name: Ashraf Ale Yasin, MD
role: STUDY_CHAIR
affiliation: Omid Fertility Center
name: Marzieh Agha Hosseini, MD
role: STUDY_CHAIR
affiliation: Omid FC
name: Hojatollah Saeidi Saeid Abadi, P.H.D
role: STUDY_CHAIR
References: