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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eTEP-RS Technique | Experimental | Patients undergoing laparoscopic abdominal wall hernia repair using the eTEP-RS (Enhanced View Totally Extraperitoneal-Retromuscular) technique. |
|
| IPOM Plus Technique | Active Comparator | Patients undergoing laparoscopic abdominal wall hernia repair using the IPOM Plus technique with fascial defect closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eTEP-RS Hernia Repair | Procedure | Laparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence Rate | Clinical or radiological evidence of hernia recurrence during follow-up. | Up to 6 months post-surgery |
| Postoperative Pain Score | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Time from first incision to final closure, measured in minutes. | Intraoperative |
| Duration of Postoperative Hospital Stay | Number of days from surgery to discharge(upto 15 days post- operatively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kavita Sijwali, MBBS, MS SURGERY RESIDENT | GSVM MEDICAL COLLEGE KANPUR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gsvm Medical College Kanpur | Kanpur | Uttar Pradesh | 208002 | India |
The Inpatient Department (IPD) of the Department of General Surgery is used by multiple researchers. However, patients eligible for this study will be screened using a separate screening log. Only patients meeting the inclusion criteria and providing informed written consent will be enrolled. No overlap in participant enrollment with other interventional trials will occur. Ethical clearance has been obtained and institutional guidelines for shared clinical spaces will be followed.
6 months after primary study completion date to 5 years after study completion
Qualified researchers, academicians, and clinicians may request access to de-identified individual participant data (IPD) and supporting information including the study protocol, informed consent form (ICF), and statistical analysis plan (SAP) after the primary results have been published.
Access will be provided upon reasonable request submitted via email to the Principal Investigator. Requests must include a summary of the intended use and a data-sharing agreement to ensure compliance with confidentiality and ethical standards.
No personally identifiable data will be shared. The information will be made available through secure institutional email correspondence or a protected data-sharing platform, subject to Institutional Ethics Committee approval if required.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2025 | Jun 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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| IPOM Plus Hernia Repair | Procedure | Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias. |
|
| DAY 1 TO DAY 15 |
| Incidence of Surgical Site Occurrences (SSOs) | Includes wound infection, seroma, hematoma, or mesh-related complications occurring within 30 days | Within 30 days post-surgery |
| Time to Return to Normal Activities | 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. | Within 30 days postoperatively |