| CTRI Number |
CTRI/2024/12/077638 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Surgical Outcomes in Minimally Invasive Ventral Hernia Repair
|
|
Scientific Title of Study
|
Perioperative Outcomes of Minimally Invasive Ventral Hernia repair: An Observational Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Pachauri |
| Designation |
Junior Resident |
| Affiliation |
All india institute of medical sciences Jodhpur |
| Address |
Department of General surgery All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7891043420 |
| Fax |
|
| Email |
pachauryayush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramkaran Chaudhary |
| Designation |
Professor |
| Affiliation |
All india institute of medical sciences Jodhpur |
| Address |
Department of General surgery All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996892 |
| Fax |
|
| Email |
rkmoond@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayush Pachauri |
| Designation |
Junior Resident |
| Affiliation |
All india institute of medical sciences Jodhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7891043420 |
| Fax |
|
| Email |
pachauryayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery All india institute of medical sciences Jodhpur Marudhar Industrial Area 2nd phase MIA 1st phase Basni Jodhpur |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Department of General Surgery All india institute of medical sciences Jodhpur Marudhar Industrial Area 2nd phase MIA 1st phase Basni Jodhpur |
| 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 |
| Dr Ayush Pachauri |
Department of General Surgery All India institute of medical sciences Jodhpur |
Department of General Surgery All india institute of medical sciences Jodhpur Marudhar Industrial Area 2nd phase MIA 1st phase Basni Jodhpur 342005
Jodhpur
RAJASTHAN |
7891043420
pachauryayush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committees AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients more than 18 years of ventral hernia requiring surgery
Patient fit for undergoing general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients who deny consent for inclusion in the study
Patients less than 18 years of age |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate postoperative pain in patients undergoing minimally invasive ventral hernioplasty on the basis of Visual Assessment Score |
30 days post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of surgery
Intraoperative complications
Postoperative Complications (Hematoma, Seroma, Infection)
Length of hospital stay
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In summary, this observational study aims to provide a comprehensive analysis of the early post-operative outcomes of minimally invasive ventral hernioplasty. By elucidating the benefits, challenges, and potential pitfalls associated with this surgical modality, this research endeavors to contribute valuable insights to the field of hernia surgery, ultimately advancing the care and management of patients with ventral hernias
|