| CTRI Number |
CTRI/2024/01/061886 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
LIRA vs IPOM Plus in Anterior Abdominal Wall Hernia Repair in terms of early post operative complications |
|
Scientific Title of Study
|
A randomised controlled study to compare Laparoscopic Intracorporeal Rectus Aponeuroplasty (LIRA) and Intraperitoneal Onlay Mesh Repair (IPOM Plus) Plus in terms of early post-operative complications in ventral hernia repair |
| 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 VATSAL GUPTA |
| Designation |
PG RESIDENT |
| Affiliation |
Department of General Surgery |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital New Delhi
Central DELHI 110001 India |
| Phone |
7289053837 |
| Fax |
|
| Email |
drvatsalgupta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR NEETI KAPUR |
| Designation |
PROFESSOR |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of General Surgery
Dr. Ram Manohar Lohia Hospital New Delhi India
Central DELHI 110001 India |
| Phone |
9818182212 |
| Fax |
|
| Email |
neetikapur2004@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
DR SHARDOOL VIKRAM GUPTA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of General Surgery
Dr. Ram Manohar Lohia Hospital New Delhi India
Central DELHI 110001 India |
| Phone |
9971265738 |
| Fax |
|
| Email |
docshardool@gmail.com |
|
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Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital New Delhi |
| Address |
Department of General surgery
ABVIMS and Dr RML hospital New Delhi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VATSAL GUPTA |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
Department of general surgery, Dr Ram Manohar Lohia Hospital, New Delhi Central DELHI |
7289053837
drvatsalgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, (3) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, (4) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraperitoneal Onlay Mesh Repair Plus (IPOM PLUS) |
IPOM PLUS will be used for the treatment of ventral hernias over a period of 1 year. IPOM Plus is an established technique for ventral hernia repair. |
| Intervention |
Laparoscopic Intracorporeal Rectus Aponeuroplasty (LIRA) |
LIRA will be used for the treatment of ventral hernias over a period of 1 year. LIRA is a relatively newer technique for ventral hernia repair. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ADULT PATIENTS WITH PRIMARY VENTRAL HERNIA |
|
| ExclusionCriteria |
| Details |
Recurrent ventral hernia
Obstructed or strangulated hernia
ASA 3 or more |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Early post-operative complications
Pain
Seroma
Surgical site infection |
1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra-op complications
Operative Time
Length of hospital stay |
1 month |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2024 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Hernia is defined as abnormal protrusion of an organ or tissue through an opening in the layer of the body that normally contains it.
Hernias may be broadly divided into two main groups, depending on whether they develop in the upper abdomen or in the groin, and each group contains multiple types. The European Hernia Society (EHS) has introduced a system of classifications of inguinal and ventral (primary and incisional) hernias. , which is used in another EHS project—the European Registry of Abdominal Wall Hernias. The presentation of a ventral hernia is usually pain, swelling or fullness at the site of occurrence that can change with position or Valsalva, except in case of incarcerated or strangulated hernias, which may cause erythema and asymmetry as well. In most cases, the diagnosis of a ventral hernia can be made by history and physical exam.
The placement of an intraperitoneal mesh (IPOM) bridging the defect was related to a bulging effect after a certain period of time (pseudo-recurrence). An alternative in order to avoid this last problem and to increase the functionality of the abdominal wall was proposed by performing the closure of the defect by laparoscopy before placing the mesh (IPOM Plus), although some studies have suggested that the tension generated in the midline by closure of defect could be associated with an increase in the rate of pain and recurrence.
These problems led to the development of Laparoscopicintracorporeal rectus aponeuroplasty (LIRA), a new laparoscopic technique for the treatment of ventral moderate defects by J Gomez-Menchero et al in 2017. This technique combines the advantages of both concepts: the minimally invasive approach and the abdominal wall reconstruction associated to Closure of defect, allowing a restoration of the midline without tension, by the plication of the posterior aponeurosis of both abdominal rectus muscles combined with a laparoscopic intraperitoneal prosthetic repair (intraperitoneal onlay mesh).
This study aims at comparing the efficiency, advantages, disadvantages, limitations, early post-operative complications defined by post-operative pain, seroma formation, surgical site infection and recurrence of hernia with Laparoscopicintracorporeal rectus aponeuroplasty (LIRA) and Intraperitoneal onlay mesh plus repair (IPOM Plus repair) to determine whether these techniques are comparable. |