An interventional study of Combined Microscopic Varicocelectomy and Inguinal and Subinguinal varicocelectomy in Varicocele, sponsored by Omid Fertility Center. Completed at 1 site in Iran, Islamic Republic of. Open to male participants. Per ClinicalTrials.gov, last updated 2015-07-03.
Sponsored by Omid Fertility Center · Not applicable, Interventional, and Treatment
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
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.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's enrollment of 570 is above the median of 72 across 36 interventional studies indexed under Varicocele.
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Exclusion Criteria:
Patients in this arm were operated with Combined Mini-incision Microscopic approach
Procedure: Combined 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 associates
Procedure: Inguinal and Subinguinal 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
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.
Recurrent Varicocele
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
Time frame: 6 months
Post-varicocelectomy Hydrocele
Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery
Time frame: 6months
Post-varicocelectomy Testicular Atrophy
development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery
Time frame: 6months
| Milestone | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy |
|---|---|---|
| Started | 285 | 285 |
| Completed | 285 | 285 |
| Not completed | 0 | 0 |
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
| participants | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy |
|---|---|---|
| Recurrent Varicocele | 2 | 16 |
Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery
| Participants | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy |
|---|---|---|
| Post-varicocelectomy Hydrocele | 0 | 0 |
development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery
| Participants | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy |
|---|---|---|
| Post-varicocelectomy Testicular Atrophy | 0 | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combined Microscopic Varicocelectomy | — | 0/285 (0%) | 2/285 (0.7%) |
| Inguinal and Subinguinal Varicocelectomy | — | 0/285 (0%) | 16/285 (5.6%) |
| Event | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy |
|---|---|---|
| Testicular AtrophyReproductive system and breast disorders | 0/285 | 0/285 |
| Event | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy |
|---|---|---|
| Recurrent VaricoceleReproductive system and breast disorders | 2/285 | 16/285 |
| HydroceleReproductive system and breast disorders | 0/285 | 0/285 |
| Age, Continuous(years) | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy | Total |
|---|---|---|---|
| Mean | 31.2 (16 to 40) | 31.8 (22 to 39) | 31.5 (16 to 40) |
| Sex: Female, Male(Participants) | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 285 | 285 | 570 |
| Region of Enrollment(participants) | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy | Total |
|---|---|---|---|
| Iran, Islamic Republic of | 285 | 285 | 570 |
The record gives a start of Jan 2006, a primary completion of Sep 2013 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 9 months after primary completion.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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