| CTRI Number |
CTRI/2026/04/108275 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized controlled trial comparing suture ligation versus herniotomy sans ligation in pediatric hydrocele repair. |
|
Scientific Title of Study
|
Comparative Evaluation of Suture Ligation of the Processus Vaginalis versus Herniotomy sans ligation in Pediatric Hydrocele Repair: A Randomized Controlled Trial |
| 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 Rajpal Singh Sisodiya |
| Designation |
Consultant Pediatric Surgeon |
| Affiliation |
Netaji Subhas Chandra Bose,Medical college,Jabalpur MP |
| Address |
Department Of Pediatric Surgery
Netaji Subhas Chandra Bose, Medical College, Nagpur road, JABALPUR,
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
09654811772 |
| Fax |
|
| Email |
rssisodiyanscbpediasurgery@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajpal Singh Sisodiya |
| Designation |
Consultant Pediatric Surgeon |
| Affiliation |
Netaji Subhas Chandra Bose Medical college, Jabalpur, MP |
| Address |
Department Of Pediatric Surgery
WARD NO 21 ,
Netaji Subhas Chandra Bose Medical College, JABALPUR, NAGPUR ROAD, MP, INDIA 482003
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
09654811772 |
| Fax |
|
| Email |
rssisodiyanscbpediasurgery@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajpal Singh Sisodiya |
| Designation |
Consultant Pediatric Surgeon |
| Affiliation |
Netaji Subhas Chandra Bose,Medical college ,Jabalpur MP |
| Address |
Department Of Pediatric Surgery
Netaji Subhas Chandra Bose,Medical College, NAGPUR ROAD JABALPUR MP INDIA
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
09654811772 |
| Fax |
|
| Email |
rssisodiyanscbpediasurgery@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multi disciplinary reaserch unit, Netaji Subhas Chandra Bose Medical college ,NAGPUR ROAD , 482003 ,JABALPUR MP INDIA |
|
|
Primary Sponsor
|
| Name |
Multi disciplinary research unit Netaji Subhas Chandra Bose Medical College Jabalpur MP INDIA |
| Address |
MDRU , NSCB Medical College, Nagpur road 482003, Jabalpur MP INDIA |
| 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 |
| Rajpal Singh Sisodiya |
Netaji Subhas Chandra Bose, Medical college and hospital , Jabalpur 482003 MP INDIA |
Department Of Pediatric Surgery, WARD NO-21, Main hospital building
NSCB Medical College and associated hospital , JABALPUR
Jabalpur
MADHYA PRADESH |
09654811772
rssisodiyanscbpediasurgery@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, NSCB Medical College,Jabalpur (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N433||Hydrocele, unspecified, (2) ICD-10 Condition: N433||Hydrocele, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herniotomy sans ligation |
Hernitomy sans ligation means ligation sac with bipolar cuatery without suture matareial |
| Comparator Agent |
Herniotomy with suture ligation |
Herniotomy with ligation of the suture is the conventional way |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
Age 1 to 12 years
Unilateral or bilateral congenital hydrocele that requires surgical intervention. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare operative time between conventional suture ligation versus herniotomy sans ligation during open herniotomy for pediatric hydrocele.
2. To compare recurrence of hydrocele or development of inguinal hernia at 12 months.
|
1.Operative time from skin incision to sac ligation and skin-to-skin (intraoperative)
2. Recurrence of hydrocele or development of inguinal hernia at 12 months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess early postoperative complications (edema, hematoma, wound infection). |
WITHIN 6 WEEKS FROM DATE OF SURGERY |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This randomized controlled trial aims to compare suture ligation of the processus vaginalis with herniotomy without ligation in children undergoing surgery for hydrocele. Pediatric hydrocele repair is commonly performed using traditional high ligation, although newer sutureless techniques may reduce operative time and avoid suture-related complications. However, high-quality comparative evidence is lacking. A total of 100 children aged 1 to 12 years with congenital hydrocele will be randomly assigned to two groups. One group will undergo conventional herniotomy with suture ligation, while the other will undergo herniotomy without ligation. The primary outcome is operative time, recurrence. Secondary outcomes include postoperative complications such as edema, hematoma, and infection, need for reoperation, and recovery parameters. The study is a parallel-group, assessor-blinded, randomized trial conducted at a tertiary care center. Follow-up will last up to 12 months to assess recurrence and complications. This study aims to provide evidence on the safety and effectiveness of sutureless herniotomy and may help improve surgical practice in pediatric hydrocele repair by reducing operative time without increasing recurrence or complications.
|