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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

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 - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075238
Enrollment
58
Registered
2024-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K439- Ventral hernia without obstructionor gangrene Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 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

Sponsors

Dr Aditya Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Incisional hernia 2. Multiple hernias 3. Complicated hernia (Obstruction, Strangulation) 4. Age less than 18 years 5. Emergency surgery

Design outcomes

Primary

MeasureTime frame
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)Timepoint: early (6hours, 24 hours and at discharge) and late (3 to 6 months)

Secondary

MeasureTime frame
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)Timepoint: early (6hours, 24 hours and at discharge) and late (3 to 6 months)

Countries

India

Contacts

Public ContactDr Manoj

ALL INDIA INSTITUTE OF MEDICAL SCIENCES DELHI

dradityakumar@aiims.edu9818713124

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026