| CTRI Number |
CTRI/2025/10/096717 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on a Laparoscopic Surgery Technique to Repair Groin Hernias and Prevent Fluid Collection After Surgery in Puducherry |
|
Scientific Title of Study
|
A Prospective Observational study on Transabdominal Preperitoneal
Repair: Following Plication of Pseudosac and its Effect on Seroma Formation i n a Tertiary Care
Hospital at Puducherry |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajiv Marechal |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateshwaraa medical college and research centre |
| Address |
Room no: 11
Department of general surgery
Sri Venkateshwaraa medical college and research centre
13A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605 102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8870315141 |
| Fax |
|
| Email |
marajiv30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh amal praveen |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateshwaraa medical college and research centre |
| Address |
Room no: 11
Department of general surgery
Sri Venkateshwaraa medical college and research centre
13A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605 102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6379559239 |
| Fax |
|
| Email |
versta_3500@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DrRajiv Marechal |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateshwaraa medical college and research centre |
| Address |
Room no: 11
Department of general surgery
Sri Venkateshwaraa medical college and research centre
13A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605 102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8870315141 |
| Fax |
|
| Email |
marajiv30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no: 11
Department of general surgery
Sri Venkateshwaraa medical college and research centre
13A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605 102 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwara medical college and research centre |
| Address |
13A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605 102 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRajiv marechal |
Sri Venkateshwara medical college and research centre |
Room no: 11
Department of general surgery
Sri Venkateshwaraa medical college and research centre
13A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605 102
Pondicherry
PONDICHERRY |
8870315141
marajiv30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics committee ( Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Plication of the Pseudosac during Transabdominal Preperitoneal (TAPP) Repair. |
Plication of the Pseudosac during Transabdominal Preperitoneal (TAPP) Repair.
• Procedure: Patients scheduled for elective laparoscopic TAPP repair will undergo the standard operative steps.
• Intervention Step: During surgery, if a pseudosac is identified intraoperatively, it will be plicated.
• Operational Definition: Plication refers to suturing the pseudosac to collapse or obliterate the potential dead space that forms during the TAPP repair procedure, thereby potentially reducing postoperative seroma formation.
. Target Population: This intervention will be applied to patients in whom a pseudosac is identified during the course of the laparoscopic TAPP repair. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above diagnosed with inguinal hernia (unilateral or bilateral), undergoing elective TAPP repair, with intraoperative identification of a pseudosac, and providing written informed consent. |
|
| ExclusionCriteria |
| Details |
Recurrent inguinal hernia requiring redo TAPP repair; complicated hernias (strangulated/obstructed/irreducible requiring bowel resection); contraindications to laparoscopy; significant coagulopathy or on long-term anticoagulation; active systemic or local infection; or declining consent/lost to follow-up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Seroma formation |
Postoperative Days (POD) 3, 7, 14, and 1 Month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative Pain |
POD 0 (6 hours post-op), 1, 3, 7, 14, and 1 Month. |
| Length of Hospital Stay |
At Discharge (End of hospital stay). |
| Postoperative Complications |
Throughout the 1-month follow-up period. |
| Recurrence |
At 1-month follow-up. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
24/11/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [marajiv30@gmail.com].
- For how long will this data be available start date provided 22-11-2025 and end date provided 22-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The primary purpose of this protocol is to evaluate whether plication (suturing) of the pseudosac during laparoscopic Transabdominal Preperitoneal (TAPP) repair for inguinal hernia reduces the occurrence of postoperative seroma (fluid buildup) in patients at a tertiary care hospital in Puducherry. The study hypothesis is that pseudosac plication during TAPP repair can lower postoperative seromas, thus improving recovery and surgical outcomes for patients with inguinal hernia |