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CTRI Number  CTRI/2024/10/075238 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing pain, quality of life and cost between two laparoscopic techniques for ventral hernia repair - ventral transabdominal preperitoneal (vTAPP) plus and intraperitoneal onlay mesh (IPOM) plus 
Scientific Title of Study   Randomised control trial comparing pain, quality of life and cost between laparoscopic ventral transabdominal preperitoneal (vTAPP) plus vs. intraperitoneal onlay mesh (IPOM) plus repair for primary ventral hernia 
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 Aditya Kumar 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES DELHI 
Address  Room No 425, Fourth Floor, Surgery Block, AIIMS Delhi

South West
DELHI
110049
India 
Phone  9818713124  
Fax    
Email  dradityakumar@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditya Kumar 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES DELHI 
Address  Room No 425, Fourth Floor, Surgery Block, AIIMS Delhi

South West
DELHI
110049
India 
Phone  9818713124  
Fax    
Email  dradityakumar@aiims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Manoj 
Designation  MS General Surgery 
Affiliation  AIIMS DELHI 
Address  Room No 425, Fourth Floor, Surgery Block, AIIMS Delhi

South West
DELHI
110049
India 
Phone  9991233274  
Fax    
Email  mansoni148@gmail.com  
 
Source of Monetary or Material Support  
AIIMS NEW DELHI 
 
Primary Sponsor  
Name  Dr Aditya Kumar 
Address  Room No 425, Fourth Floor, Surgery Block, AIIMS Delhi 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditya Kumar  All India Institute of Medical Sciences Delhi  Department of Surgical Disciplines, Surgery Block
South West
DELHI 
9818713124

dradityakumar@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee AIIMS ot block Ansari Nagar New Delhi 29  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intraperitoneal Onlay Mesh (IPOM) Plus  Under general anesthesia, the patient is placed in a supine position with a slight Trendelenburg tilt with arms on side. Port placement is tailored to the location of the hernia defect. Adhesions are lysed to free the hernia defect, and the hernia sac and contents are carefully reduced back into the abdominal cavity. The hernia defect is closed using sutures to approximate the edges, reducing the size of the defect. A dual layered composite mesh (absorbable surface towards bowel and synthetic surface towards parietal peritoneum) is introduced into the abdominal cavity and positioned over the closed defect, ensuring adequate overlap of approx 5cm or according to size of defect. The mesh is then anchored to the abdominal wall using tacks, transfascial sutures and/or peritoneal sutures. Finally, the pneumoperitoneum is released, and the trocar sites are closed with sutures or staples. 
Intervention  ventral Transabdominal Preperitoneal (vTAPP) Plus  Under general anesthesia, the patient is placed in a supine position with arms on side. Port placement is tailored to the location of the hernia defect. Three trocars are inserted into the abdomen. Intraoperative findings will be noted, and the hernia contents will be reduced. Non- absorbable polypropylene sutures will be taken transfascially to close the primary defect. Aperitoneal incision will then be made five centimeters away from the hernia defect to raise the peritoneal flap and dissection of flap will be continued for 5 centimeters on all sides of the defect. A synthetic polypropylene mesh will be introduced and positioned over the hernia defect with adequate overlap of approx 5cm on all sides of the defect. The mesh will be anchored using tackers, sutures, or a combination. The peritoneal flap is then closed over the mesh with sutures or tacks, forming a barrier between the mesh and abdominal organs. Finally, the pneumoperitoneum is released, and the trocar sites are closed with sutures or staples. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Primary midline ventral hernia
2. Hernia defect size 2 – 5 cm
3. Able to tolerate general anesthesia
4. Patients provide written consent to be enrolled in the trial. 
 
ExclusionCriteria 
Details  1. Incisional hernia
2. Multiple hernias
3. Complicated hernia (Obstruction, Strangulation)
4. Age less than 18 years
5. Emergency surgery 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare post-operative pain scores using the visual analogue scale (VAS) score
2.To evaluate early quality of life
scores using European Registry of Abdominal Wall Hernias Quality of Life (EuraHS-QoL) 
early (6hours, 24 hours and at discharge) and late (3 to 6 months) 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare total post operative analgesics dose

2. To conduct a cost-effectiveness analysis comparing the direct medical costs associated with each surgical technique over the study period, including cost of equipments, procedural costs, hospitalization costs, and costs of managing postoperative complications.

3. To evaluate surgical outcomes (operative time, conversion, length of hospital stay and complications) 
early (6hours, 24 hours and at discharge) and late (3 to 6 months) 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   20/10/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Primary ventral hernia repair is a common surgical procedure, but the optimal technique for achieving the best outcomes remains a topic of ongoing debate. The standard technique, Intraperitoneal Onlay Mesh (IPOM) plus, has been widely used and studied. Although it is technically easy to perform, presence of an intraperitoneal mesh and use of tackers has potential to cause life threatening complications such as severe post-operative pain, adhesive intestinal obstruction, fistulas and abscess. Besides this, as the mesh is placed intra-peritoneally, a composite (dual layered) mesh is needed and tacking devices to fix the mesh. This leads to increased costs when compared to use of a single layered polypropylene mesh without need for tackers. These reasons eventually impact on the patients’ quality of life in the long term. Due to these reasons, attempts have been made to develop other techniques which allow placement of mesh outside the peritoneal cavity and remove the need to use fixation devices. Some surgeons are employing techniques, which place mesh in the retrorectus space, however, they need extensive dissection and division of the natural structures such as the posterior rectus sheath, which may have potential to cause hernia recurrence on the long run. Hence, attempts have been made to place the mesh in the pre- peritoneal space trans-abdominally. This technique of ventral transabdominal pre-peritoneal repair (vTAPP) is derived from the transabdominal preperitoneal repair (TAPP) used for inguinal hernia repairs routinely. The technique prevents use of intraabdominal mesh, avoids the need for fixation devices such as tackers and avoids the use of a composite mesh. Thereby, reducing product cost and avoiding the potential complications, especially severe pain, adhesions and fistula formation. However, these techniques are technically difficult to perform. Some retrospective studies are available in literature with conflicting results. Hence, we designed this randomized controlled trial comparing Laparoscopic vTAPP Plus versus the standard IPOM Plus for Ventral Hernia Repair in terms of outcomes, quality of life and cost effectiveness.
 
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