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

• Sponsor: Omid Fertility Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02092311
• Collaborator: Shahid Beheshti University of Medical Sciences (Other)
• Enrollment: 570
• Location: 1
• Arms: 2
• Duration (Months): 113
• Patients Per Site Per Month: 5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Varicocele	Procedure: Combined Microscopic Varicocelectomy; Procedure: Inguinal and Subinguinal varicocelectomy	N/A

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.

Study Design

• Study Type: Interventional
• 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: Jan 1, 2006
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Recurrent Varicocele [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 [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 [6months]

   development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Omid fertility center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Omid Fertility Center
• Shahid Beheshti University of Medical Sciences

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omid Fertility Center
• ClinicalTrials.gov Identifier: NCT02092311
• Other Study ID Numbers: CMMV
• First Posted: Mar 20, 2014
• Last Update Posted: Jul 3, 2015
• Last Verified: Jun 1, 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: Varicocele

Study Results

Participant Flow

Arm/Group Title	Combined Microscopic Varicocelectomy	Inguinal and Subinguinal Varicocelectomy
Arm/Group Description	Combined Mini-Incision Microscopic 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 associate
Period Title: Overall Study
STARTED	285	285
COMPLETED	285	285
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Combined Microscopic Varicocelectomy	Inguinal and Subinguinal Varicocelectomy	Total
Arm/Group Description	Patients underwent Combined Mini-incision Microscopic 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 associate	Total of all reporting groups
Overall Participants	285	285	570
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	31.2	31.8	31.5
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	285 100%	285 100%	570 100%
Region of Enrollment (participants) [Number]
Iran, Islamic Republic of	285 100%	285 100%	570 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Microscopic Varicocelectomy	Inguinal and Subinguinal Varicocelectomy
Arm/Group Description	Patients underwent Combined Mini-incision Microscopic 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 associate
Measure Participants	285	285
Number [participants]	2 0.7%	16 5.6%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Microscopic Varicocelectomy	Inguinal and Subinguinal Varicocelectomy
Arm/Group Description	Patients underwent Combined Mini-incision Microscopic 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 associate
Measure Participants	285	285
Number [Participants]	0 0%	0 0%

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combined Microscopic Varicocelectomy	Inguinal and Subinguinal Varicocelectomy
Arm/Group Description	Patients underwent Combined Mini-incision Microscopic 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 associate
Measure Participants	285	285
Number [Participants]	0 0%	0 0%

Adverse Events

Time Frame	6 months
Arm/Group Title	Combined Microscopic Varicocelectomy		Inguinal and Subinguinal Varicocelectomy
Arm/Group Description	Patients underwent Combined Mini-incision Microscopic 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 associate
All Cause Mortality
	Combined Microscopic Varicocelectomy		Inguinal and Subinguinal Varicocelectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Combined Microscopic Varicocelectomy		Inguinal and Subinguinal Varicocelectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/285 (0%)		0/285 (0%)
Reproductive system and breast disorders
Testicular Atrophy	0/285 (0%)	0	0/285 (0%)	0
Other (Not Including Serious) Adverse Events
	Combined Microscopic Varicocelectomy		Inguinal and Subinguinal Varicocelectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/285 (0.7%)		16/285 (5.6%)
Reproductive system and breast disorders
Recurrent Varicocele	2/285 (0.7%)		16/285 (5.6%)
Hydrocele	0/285 (0%)		0/285 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.