| CTRI Number |
CTRI/2025/02/080757 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare intraoperative and postoperatvie complication by defect closure in a laparoscopic hernia repair |
|
Scientific Title of Study
|
Prospective study of comparison of IPOM (Intraperitoneal onlay mesh repair) Vs
IPOM Plus (Intraperitoneal onlay mesh repair with fascia repair) in ventral abdominal wall
hernia repair in a tertiary care setting in Nagpur |
| 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 Shiv N Kandoi |
| Designation |
Junior Resident |
| Affiliation |
All India Medical Institute of Sciences,Nagpur |
| Address |
Room no 202 , OPD building , Department of General Surgery, All India Medical Institute of Sciences,Mihan, Dahegaon, Nagpur,MAHARASHTRA
441108
India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
8379919720 |
| Fax |
|
| Email |
shiv.kandoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupendra Mehra |
| Designation |
Professor |
| Affiliation |
All India Medical Institute of Sciences,Nagpur |
| Address |
Room no 204 , OPD building , Department of General Surgery, All India Medical Institute of Sciences,Mihan, Dahegaon, Nagpur,MAHARASHTRA
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9822817958 |
| Fax |
|
| Email |
drbmehra@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupendra Mehra |
| Designation |
Professor |
| Affiliation |
All India Medical Institute of Sciences,Nagpur |
| Address |
Room no 204 , OPD building , Department of General Surgery, All India Medical Institute of Sciences,Mihan, Dahegaon, Nagpur,MAHARASHTRA
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9822817958 |
| Fax |
|
| Email |
drbmehra@aiimsnagpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 |
|
|
Primary Sponsor
|
| Name |
Dr Shiv N Kandoi |
| Address |
Room no 202 , OPD building , Department of General Surgery, All India Medical Institute of Sciences,Mihan, Dahegaon, Nagpur,MAHARASHTRA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shiv Kandoi |
All India Institute of Medical Sciences, Nagpur |
Room no 202,
Department of General
Surgery, All India
Institute of Medical
Sciences, Mihan,
Dahegaon, Nagpur
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
8379919720
shiv.kandoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
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: K43||Ventral hernia, (3) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraperitoneal onlay mesh repair |
In this group for hernia, Laparoscopic technique will use place the mesh but the defect will not be closed over a period of one and half year |
| Intervention |
Intraperitoneal onlay mesh repair plus |
In this group of hernia repair, Laparoscopic technique will be used to place mesh and also to close the defect over a period of one and half year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Patients more than 18 yrs of age
Patients having ventral abdominal wall hernia |
|
| ExclusionCriteria |
| Details |
Cases who are admitted under emergency and have strangulated hernia and not fit for laparoscopy hernioplasty
Patients less than 18yrs of age
Those who needed abdominal wall reconstruction
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess occurrence of recurrence of ventral abdominal hernia in between IPOM and IPOM Plus |
To assess occurrence of recurrence of ventral abdominal hernia in between IPOM and IPOM Plus at 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
seroma formation
wound infection
Pain
Length of hospital stay
Recurrence after 6 months & more
|
seroma formation at day 1 day 3 day 7
wound infection after 24 hrs
Pain at 6 hrs 12 hrs 1 day 7 day
Length of hospital stay less than 3 day more than 3 day
Recurrence after 6 months & more
|
Intraoperative time required for the surgery
Injury to bladder / Bowel
Injury to blood vessel
|
Intraoperative time required for the surgery
Injury to bladder / Bowel
Injury to blood vessel
|
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The laparoscopic repair of ventral hernias consisting of bridging the defect from the peritoneal side with a composite mesh, known as the intra-peritoneal onlay mesh (IPOM) repair was considered as a standard technique. However, such repair is associated with a significant incidence of post-operative bulging or eventration of mesh, seromas, recurrences, and non-restoration of abdominal muscle function . To circumvent these problems, sutured closure of the defect in the fascia with intra-peritoneal mesh reinforcement has been described, termed as IPOM-Plus repair. |