| 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
|
|
|
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
|
|
|
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
|
|
|
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. |