Abdominal Hernia, Ventral Hernia Repair
Conditions
Keywords
Etep-rs and ipom plus, Ventral hernia, Mesh repair
Brief summary
This study aims to compare the outcomes of Enhanced View Totally Extraperitoneal Rives-Stoppa (eTEP-RS) repair and Intraperitoneal Onlay Mesh Plus (IPOM Plus) repair in the management of ventral wall hernias. The comparison includes operative time, post-operative pain, hospital stay, surgical site occurrences, and recurrence rates. Patients will be prospectively enrolled and allocated into two groups based on the surgeon's discretion or patient-specific criteria.
Detailed description
Abdominal wall hernias are common surgical conditions, and multiple techniques have evolved for their repair. eTEP-RS is a relatively newer, minimally invasive approach that combines the principles of the Rives-Stoppa retromuscular mesh placement with the benefits of laparoscopic surgery. IPOM Plus, on the other hand, is a widely practiced technique involving intraperitoneal mesh placement with defect closure. This prospective comparative study is designed to evaluate the effectiveness and safety of eTEP-RS versus IPOM Plus in patients undergoing elective repair of ventral or incisional hernias. The study will assess intra-operative parameters (e.g., duration of surgery, blood loss), early post-operative outcomes (pain score, duration of hospital stay), surgical site complications (seroma, infection, mesh-related issues), and long-term outcomes (recurrence, quality of life). Patients fulfilling inclusion criteria will be assigned to one of the two arms. Standardized protocols will be followed for pre-operative work-up, anesthesia, surgical steps, and post-operative care. Data will be analyzed to determine if one technique offers superior clinical outcomes, better patient satisfaction, or reduced recurrence
Interventions
PROCEDUREeTEP-RS Hernia Repair
Laparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia.
PROCEDUREIPOM Plus Hernia Repair
Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias.
Sponsors
GSVM Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm parallel group randomized controlled trial comparing eTEP-RS and IPOM Plus for elective abdominal wall hernia repair. Eligible participants are randomly assigned to one of the two surgical techniques. Both groups are followed in parallel to assess intraoperative, postoperative, and follow-up outcomes including pain, hospital stay, complications, and recurrence.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patient with uncomplicated ventral hernia with defect size between 2 cm and 5 cm * Age between 18 years and 60 years. * elective surgical cases(non emergency)
Exclusion criteria
* defect size greater than 5 cm. * patient not giving consent. * patient with lateral HERNIAS. * patient with complicated ventral HERNIAS like irreducible , obstructed and strangulated HERNIAS. * pregnant and lactating women. * patient on anticoagulants. * recurrent hernia. * patient not fit for GA. * POOR GENERAL CONDITION.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence Rate | Up to 6 months post-surgery | Clinical or radiological evidence of hernia recurrence during follow-up. |
| Postoperative Pain Score | 6 months | Postoperative pain will be assessed using the Visual Analogue Scale (VAS) 24 hours, and 7 days, 30 days and 6 months after surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where: 0 = No pain 10 = Worst imaginable pain Higher scores indicate a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperative | Time from first incision to final closure, measured in minutes. |
| Duration of Postoperative Hospital Stay | DAY 1 TO DAY 15 | Number of days from surgery to discharge(upto 15 days post- operatively) |
| Incidence of Surgical Site Occurrences (SSOs) | Within 30 days post-surgery | Includes wound infection, seroma, hematoma, or mesh-related complications occurring within 30 days |
| Time to Return to Normal Activities | Within 30 days postoperatively | Number of days taken by the patient to resume routine daily activities, such as walking without support, household tasks, or returning to work, as reported during follow-up. |
Countries
India
Outcome results
None listed