Varicocele
Conditions
Keywords
varicocele, varicocelectomy, complications of varicocelectomy, Recurrence of varicocele, Post-varicocelectomy testicular atrophy, Post-varicocelectomy hydrocele
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.
Interventions
PROCEDURECombined 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
PROCEDUREInguinal 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.
Sponsors
Shahid Beheshti University of Medical Sciences
Omid Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Varicocele | 6 months | post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-varicocelectomy Hydrocele | 6months | Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-varicocelectomy Testicular Atrophy | 6months | development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined Microscopic Varicocelectomy Patients underwent Combined Mini-incision Microscopic Varicocelectomy | 285 |
| 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 associate | 285 |
| Total | 570 |
Baseline characteristics
| Characteristic | Combined Microscopic Varicocelectomy | Inguinal and Subinguinal Varicocelectomy | Total |
|---|---|---|---|
| Age, Continuous | 31.2 years | 31.8 years | 31.5 years |
| Region of Enrollment Iran, Islamic Republic of | 285 participants | 285 participants | 570 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 285 Participants | 285 Participants | 570 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 285 | 16 / 285 |
| serious Total, serious adverse events | 0 / 285 | 0 / 285 |
Outcome results
Primary
Recurrent Varicocele
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Microscopic Varicocelectomy | Recurrent Varicocele | 2 participants |
| Inguinal and Subinguinal Varicocelectomy | Recurrent Varicocele | 16 participants |
Secondary
Post-varicocelectomy Hydrocele
Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery
Time frame: 6months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Microscopic Varicocelectomy | Post-varicocelectomy Hydrocele | 0 Participants |
| Inguinal and Subinguinal Varicocelectomy | Post-varicocelectomy Hydrocele | 0 Participants |
Other Pre-specified
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined Microscopic Varicocelectomy | Post-varicocelectomy Testicular Atrophy | 0 Participants |
| Inguinal and Subinguinal Varicocelectomy | Post-varicocelectomy Testicular Atrophy | 0 Participants |