Trial Outcomes & Findings for Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy (NCT NCT02092311)
NCT ID: NCT02092311
Last Updated: 2015-07-03
Results Overview
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
570 participants
Primary outcome timeframe
6 months
Results posted on
2015-07-03
Participant Flow
Participant milestones
| Measure |
Combined Microscopic Varicocelectomy
Combined Mini-Incision Microscopic Varicocelectomy
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
285
|
|
Overall Study
COMPLETED
|
285
|
285
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy
Baseline characteristics by cohort
| Measure |
Combined Microscopic Varicocelectomy
n=285 Participants
Patients underwent Combined Mini-incision Microscopic Varicocelectomy
|
Inguinal and Subinguinal Varicocelectomy
n=285 Participants
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
n=570 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
n=99 Participants
|
31.8 years
n=107 Participants
|
31.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
285 Participants
n=99 Participants
|
285 Participants
n=107 Participants
|
570 Participants
n=206 Participants
|
|
Region of Enrollment
Iran, Islamic Republic of
|
285 participants
n=99 Participants
|
285 participants
n=107 Participants
|
570 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthspost-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
Outcome measures
| Measure |
Combined Microscopic Varicocelectomy
n=285 Participants
Patients underwent Combined Mini-incision Microscopic Varicocelectomy
|
Inguinal and Subinguinal Varicocelectomy
n=285 Participants
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
|
|---|---|---|
|
Recurrent Varicocele
|
2 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 6monthsDevelopment of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery
Outcome measures
| Measure |
Combined Microscopic Varicocelectomy
n=285 Participants
Patients underwent Combined Mini-incision Microscopic Varicocelectomy
|
Inguinal and Subinguinal Varicocelectomy
n=285 Participants
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
|
|---|---|---|
|
Post-varicocelectomy Hydrocele
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6monthsdevelopment of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery
Outcome measures
| Measure |
Combined Microscopic Varicocelectomy
n=285 Participants
Patients underwent Combined Mini-incision Microscopic Varicocelectomy
|
Inguinal and Subinguinal Varicocelectomy
n=285 Participants
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
|
|---|---|---|
|
Post-varicocelectomy Testicular Atrophy
|
0 Participants
|
0 Participants
|
Adverse Events
Combined Microscopic Varicocelectomy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Inguinal and Subinguinal Varicocelectomy
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Microscopic Varicocelectomy
n=285 participants at risk
Patients underwent Combined Mini-incision Microscopic Varicocelectomy
|
Inguinal and Subinguinal Varicocelectomy
n=285 participants at risk
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
|
|---|---|---|
|
Reproductive system and breast disorders
Testicular Atrophy
|
0.00%
0/285 • 6 months
|
0.00%
0/285 • 6 months
|
Other adverse events
| Measure |
Combined Microscopic Varicocelectomy
n=285 participants at risk
Patients underwent Combined Mini-incision Microscopic Varicocelectomy
|
Inguinal and Subinguinal Varicocelectomy
n=285 participants at risk
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
|
|---|---|---|
|
Reproductive system and breast disorders
Recurrent Varicocele
|
0.70%
2/285 • 6 months
|
5.6%
16/285 • 6 months
|
|
Reproductive system and breast disorders
Hydrocele
|
0.00%
0/285 • 6 months
|
0.00%
0/285 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place