| CTRI Number |
CTRI/2023/08/056745 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to compare either simple placement of mesh, placement of mesh after suture closure of the hernia defect or placement of mesh after covering the defect with peritoneal tissue during laparoscopic surgery for the treatment of abdominal wall hernia.
|
|
Scientific Title of Study
|
Randomized control trial comparing laparoscopic ventral hernia repair using IPOM (intraperitoneal onlay mesh), IPOM-Plus and IPOM with peritoneal bridging techniques. |
| 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 Jitendra Kumar |
| Designation |
Specialist grade 1 & H.O.D., Department of Surgery |
| Affiliation |
Dr Babasaheb Ambedkar Medical College and Hospital |
| Address |
Unit 1, SOPD room no. – 1131 & Ward 52, Department of Surgery.
Dr Babasaheb Ambedkar Medical College and Hospital, Sector - 6, Rohini, Delhi.
Sector - 6, Rohini, Delhi.
North West
DELHI
110085
India |
| Phone |
9968242627 |
| Fax |
|
| Email |
jkumar33@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Kumar |
| Designation |
Specialist grade 1 & H.O.D., Department of Surgery |
| Affiliation |
Dr Babasaheb Ambedkar Medical College and Hospital |
| Address |
Unit 1, SOPD room no. – 1131 & Ward 52, Department of Surgery.
Dr Babasaheb Ambedkar Medical College and Hospital, Sector - 6, Rohini, Delhi.
Sector - 6, Rohini, Delhi.
North West
DELHI
110085
India |
| Phone |
9968242627 |
| Fax |
|
| Email |
jkumar33@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanisha Sinha |
| Designation |
DNB PG (Post MBBS), Surgery, Department of Surgery |
| Affiliation |
Dept of Surgery, Dr Babasaheb Ambedkar Medical College and Hospital |
| Address |
Unit 1, SOPD room no. – 1131 & Ward 52, Department of Surgery, Babasaheb Ambedkar Medical College and Hospital, Sector - 6, Rohini, Delhi.
Sector - 6, Rohini, Delhi.
North West
DELHI
110085
India |
| Phone |
7906530344 |
| Fax |
|
| Email |
drtanishasinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Baba Saheb Ambedkar Hospital, Govt of NCT Delhi. |
|
|
Primary Sponsor
|
| Name |
Dr Baba Saheb Ambedkar Hospital |
| Address |
Dr Babasaheb Ambedkar Medical College and Hospital, Sector -6, Rohini, Dehi - 110085 |
| 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 Jitendra Kumar |
Dr Baba Saheb Ambedkar Medical College &Hospital |
Unit 1, SOPD room no. – 1131 & Ward 52, Department of Surgery, Dr B. S. A. Hospital, SECTOR- 6,,ROHINI.
Delhi
North West
DELHI |
01120876658
jkumar33@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr_Baba_Saheb_Ambedkar_Medical_College_&_Hospital_Institutional_Ethics_Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra-Peritoneal Onlay Mesh (IPOM) technique of abdominal wall ventral hernioplasty |
In this arm Patients with abdominal wall hernia will be operated with laparoscopic IPOM repair technique. Total duration of study period will be 18 months after the approval from the institutional ethical committee and CTRI registration. |
| Intervention |
Intra-Peritoneal Onlay Mesh Plus (IPOM -Plus) technique of abdominal wall ventral hernioplasty |
In this arm Patients with abdominal wall ventral hernia will be operated with IPOM-PLUS technique of laparoscopic ventral hernia repair. Total duration of intervention including follow-up period will be 18 months after the approval from the institutional ethical committee and CTRI registration. |
| Intervention |
Peritoneal bridging with Laparoscopic IPOM technique of abdominal wall ventral hernioplasty |
In this arm hernia defect of patients with abdominal wall hernia will be bridged with dissected peritoneum before the placement of mesh over it. Total duration of intervention including follow-up period will be 18 months after the approval from the institutional ethical committee and CTRI registration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All consenting patients of age >18/ <70 years presenting to department of surgery for a given duration with evidence of ventral wall hernia.
2. Abdominal wall hernia with defect size of length <10cm and width <8cm. only will be included.
|
|
| ExclusionCriteria |
| Details |
1. Patients unfit for laparoscopy under general anesthesia.
2. Irreducible, strangulated or hernia with unhealthy skin over the sac.
3. Patient with BMI>35 kg/m2
4. Patient with positive viral markers i.e. HIV, HBsAg, anti-HCV
5. Recurrent Hernia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
â— To compare the incidence of development of seroma formation among the three
procedures at 48 hours & 5th day clinically & USG at 10th day after surgery.
â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days
after surgery.
â— To compare the short-term recurrence (6 months). |
â— To compare the incidence of development of seroma formation among the three
procedures at 48 hours & 5th day clinically & USG at 10th day after surgery.
â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days
after surgery.
â— To compare the short-term recurrence (6 months). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the operative time in minutes, among the three procedures.
â— To compare the duration of hospital stay in days, among the three procedures.
|
Duration of operating time in minutes & stay in the hospital after surgery in days. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2023 |
| Date of Study Completion (India) |
11/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
Common laparoscopic approaches for ventral hernia repair are simple intraperitoneal Onlay mesh (IPOM), and IPOM with defect closure before placement of mesh (IPOM-plus), Another approach IPOM with peritoneal bridging technique is also reported to be equally good. Surgical outcome among the three methods of LVHR (IPOM, IPOM-PLUS and IPOM with peritoneal bridging) is reported in the literature with a lot of subjective variation. There is also a paucity in the literature which compares these three techniques of LVHR. Our study aims at comparing the LVHR using IPOM, IPOM-PLUS, and IPOM with peritoneal bridging techniques in terms of surgical outcomes. |