| CTRI Number |
CTRI/2025/02/080189 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To analyse the effect of defect closure in laparoscopic inguinal hernia repair on post operative outcomes |
|
Scientific Title of Study
|
To analyse the effect of laparoscopic defect closure in direct inguinal hernia repairs (Total Extra-Peritoneal and Trans-Abdominal Pre-Peritoneal Plus repairs) on post operative outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABIRAMI J RAGHUNATH |
| Designation |
GENERAL SURGERY RESIDENT |
| Affiliation |
Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1
Ramachandra Nagar,
Porur,
Chennai,
Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9500013252 |
| Fax |
|
| Email |
abiraghu132@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr C D Narayanan |
| Designation |
Head of Department, Department of General Surgery |
| Affiliation |
Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1
Ramachandra Nagar,
Porur,
Chennai,
Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9500013252 |
| Fax |
|
| Email |
cdnarayanan24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Abirami J Raghunath |
| Designation |
General Surgery Resident |
| Affiliation |
Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1
Ramachandra Nagar,
Porur,
Chennai,
Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9500013252 |
| Fax |
|
| Email |
abiraghu132@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 |
|
|
Primary Sponsor
|
| Name |
Abirami J Raghunath |
| Address |
No.1 Ramachandra Nagar, Porur Chennai, Tamil Nadu, India 600 116 |
| Type of Sponsor |
Other [primary] |
|
|
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 Abirami J Raghunath |
Sri Ramachandra Institute of Higher Education and Research |
Room 207, 2nd floor, G block,
Department of General Surgery,
No.1 Ramachandra Nagar, Porur Chennai, Tamil Nadu, India 600 116 Chennai TAMIL NADU |
9500013252
abiraghu132@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee (For PG Students of Medical College) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closure of direct defect |
In laparoscopic repair of inguinal hernia, the direct defect will be closed using absorbable barbed sutures. The duration of intervention would be for the time period of study, estimated for the next one year. |
| Comparator Agent |
Non closure of direct defect |
The standard procedure for laparoscopic repair of inguinal hernia is done without closure of the defect. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective total extra-peritoneal and trans abdominal pre-peritoneal repairs for direct inguinal hernias
|
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency repair of hernia
Patients undergoing open repair
Patients undergoing hernia repair as part of another study
Patients with pre-existing infections or chronic infectious diseases such as tuberculosis
Patients not willing to participate in the study
Patients not willing for surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Seroma formation assessed clinically and using USG when required
Recurrence of inguinal hernia assessed clinically
Post operative pain assessed using visual analog scale
|
Seroma formation upto 10 days post op
Recurrence of inguinal hernia upto 3 months post op
Post operative pain upto 3 months post op
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Operative time in minutes
2.Hernia defect size & EHS classification
3.Quality of life
|
1.Intraoperative
2.Pre-operative
3.Follow up of 3 months
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="2" 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 - NO
|
|
Brief Summary
|
Following totally extraperitoneal (TOTAL EXTRA-PERITONEAL REPAIRS) and transabdominal preperitoneal (TRANS ABDOMINAL PRE-PERITONEAL PLUS REPAIRS) repair, complications such as seroma formation, hernia recurrence, and postoperative pain have continued to present challenges to surgeons. Studies have demonstrated lower post-operative pain and shorter time to recovery associated with laparoscopic inguinal hernia repair when compared to open surgery. However, some studies have also described higher rates of seroma formation (up to 12%) and recurrence (up to 5%) with laparoscopic inguinal hernia repair, which can result in decreased quality of life. In 2019, a study done in Singapore posited a modified laparoscopic technique involving primary closure of the direct hernia defect prior to mesh insertion in patients with direct inguinal hernia. They demonstrated a statistically significant reduction in recurrence and seroma formation, especially in certain at-risk patient populations, and proposed to name this procedure the “TOTAL EXTRA-PERITONEAL AND TRANS ABDOMINAL PRE-PERITONEAL PLUS†technique. Direct defect closure has proven to be effective in reducing recurrence and seroma formation post-operatively in patients undergoing laparoscopic inguinal hernia repair. The study stated that randomized controlled trials are required to further evaluate these outcomes. This is a prospective interventional parallel arm randomised controlled trial to be conducted at Sri Ramachandra Institute of Higher Education and Research. After obtaining consent, the patients will be assigned to case (closure of defect) and control (non-closure of defect) groups, using coin toss method. Closure of defect will be standardised with 2-0 VLOC barbed absorbable monofilament suture, and psuedosac will be incorporated during defect closure. Incidence of postoperative complications namely post-operative pain, seroma formation and recurrence of hernia will be compared, with serial follow-up at 1 week, 1 month, and 3 months postoperatively.
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