| CTRI Number |
CTRI/2025/09/094269 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Comparing Pre and Post Operative Outcomes after Varicocelectomy by Laparoscopic and Open Method |
|
Scientific Title of Study
|
A Study to Compare the Outcome between Laparoscopic and Open Varicocelectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shahbaz Habib Faridi |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, AMU |
| Address |
Department of Surgery, Jawaharlal Nehru Medical College, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897127431 |
| Fax |
|
| Email |
drshahbazfaridi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahbaz Habib Faridi |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, AMU |
| Address |
Department of Surgery, Jawaharlal Nehru Medical College, AMU, Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897127431 |
| Fax |
|
| Email |
drshahbazfaridi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Aadil |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, AMU |
| Address |
Department of Surgery, Jawaharlal Nehru Medical College, AMU
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9458128400 |
| Fax |
|
| Email |
aadilhmd9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Dr Mohammad Aadil |
| Address |
Department of Surgery, Jawaharlal Nehru Medical College, AMU, Aligarh (202002), UP |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Aadil |
Jawaharlal Nehru Medical College |
Department of Surgery, Jawaharlal Nehru Medical College, AMU, Aligarh, UP
Aligarh
UTTAR PRADESH |
9458128400
aadilhmd9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: I861||Scrotal varices, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Varicocelectomy |
3 Port Laparoscopic Varicocelectomy |
| Comparator Agent |
Open Varicocelectomy |
Microsurgical Subinguinal Varicocelectomy |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patient giving informed consent.
Patients with uncomplicated symptomatic unilateral/bilateral varicele.
Grade 2 and Grade 3 varicoceles |
|
| ExclusionCriteria |
| Details |
Coagulation disorder.
H/O Recurrence
H/O multiple abdominal surgery
Patients who do not give consent
Subclinical and Grade 1 varicocele
Patients requiring additional concomitant procedures |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Semen Parameters |
Before Surgery and 1 month after Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
6th hour
At discharge
After 7 days
After 3 months |
| Time to resume normal activity |
Time after which patient can walk by himself |
| Post operative complications |
6th hour
At discharge
After 7 days
After 3 months |
| Duration of surgery |
Time from incision to closure of skin |
| Hospital stay duration |
Time duration from Surgery to discharge |
| Recurrence |
After 7 days
After 3 months
After 1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare between laparoscopic varicocelectomy and open varicocelectomy in terms of
- Duration of surgery
- Post operative pain
- Post operative complications
- Duration of hospital stay
- Time to resume normal activity
- Patient satisfaction
- Residual disease/Recurrence
- Pre and Post operative semen parameters
Patients are divided in two groups in OPD by Simple randomisation method Group A - Laparoscopic Varicocelectomy Group B - Open Varicocelectomy
Patients are admitted one day prior to surgery, after surgery patient is assessed at 6th post op hour, at discharge, 7th day and after 3 months for the objectives of the study
|