Ventral Hernia RepairNCT07055464
Comparison Between eTEP-RS vs IPOM PLUS
A study testing eTEP-RS Hernia Repair and IPOM Plus Hernia Repair in people with Ventral Hernia Repair and Abdominal Hernia, run by GSVM Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ventral Hernia Repair, Abdominal Hernia
- What is being tested?
- eTEP-RS Hernia Repair and IPOM Plus Hernia Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteIndia
- Study dates
- 23 Feb 2024to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 9Show fewer
- recurrent hernia.
- patient not fit for GA.
- POOR GENERAL CONDITION.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Etep-rs and Ipom Plus for Abdominal Wall Hernias
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.
Read the 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
- Conditions
- Ventral Hernia Repair, Abdominal Hernia
- Being tested
- eTEP-RS Hernia Repair, IPOM Plus Hernia Repair
- Keywords
- Etep-rs and ipom plus, Ventral hernia, Mesh repair
- Medical subject headings
- Hernia, Abdominal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTEP-RS Hernia RepairProcedure or surgery
Laparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia.
IPOM Plus Hernia RepairProcedure or surgery
Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias.
| Study group | Role | What they receive |
|---|---|---|
| eTEP-RS Technique | Experimental | Patients undergoing laparoscopic abdominal wall hernia repair using the eTEP-RS (Enhanced View Totally Extraperitoneal-Retromuscular) technique. Receives: Procedure: eTEP-RS Hernia Repair |
| IPOM Plus Technique | Active comparator | Patients undergoing laparoscopic abdominal wall hernia repair using the IPOM Plus technique with fascial defect closure. Receives: Procedure: IPOM Plus Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence Rate
Clinical or radiological evidence of hernia recurrence during follow-up.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
Operative Time
Time from first incision to final closure, measured in minutes.
Measured: Intraoperative
Duration of Postoperative Hospital Stay
Number of days from surgery to discharge(upto 15 days post- operatively)
Measured: DAY 1 TO DAY 15
Incidence of Surgical Site Occurrences (SSOs)
Includes wound infection, seroma, hematoma, or mesh-related complications occurring within 30 days
Measured: 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.
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start23 Feb 2024
- Primary completion23 Feb 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- GSVM Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kavita Sijwali, GSVM Medical College
- Investigators
- Kavita Sijwali, MBBS, MS SURGERY RESIDENT, Principal investigator, GSVM MEDICAL COLLEGE KANPUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055464
- Sponsor's protocol ID
- ETEPIPOM2024
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Etep-rs and Ipom Plus for Abdominal Wall Hernias
- ClinicalTrials.gov ID
- NCT07055464
- Acronym / sponsor ID
- ETEPIPOM2024
- Conditions
- Ventral Hernia Repair, Abdominal Hernia
- Keywords
- Etep-rs and ipom plus, Ventral hernia, Mesh repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- GSVM Medical CollegeUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| eTEP-RS Technique | Experimental | Procedure: eTEP-RS Hernia RepairPatients undergoing laparoscopic abdominal wall hernia repair using the eTEP-RS (Enhanced View Totally Extraperitoneal-Retromuscular) technique. |
| IPOM Plus Technique | Active comparator | Procedure: IPOM Plus Hernia RepairPatients undergoing laparoscopic abdominal wall hernia repair using the IPOM Plus technique with fascial defect closure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eTEP-RS Hernia RepairLaparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia. | Procedure or surgery | eTEP-RS Technique |
| IPOM Plus Hernia RepairIntraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias. | Procedure or surgery | IPOM Plus Technique |
Primary outcome
Hernia Recurrence Rate
Time frame: Up to 6 months post-surgery
Clinical or radiological evidence of hernia recurrence during follow-up.
Postoperative Pain Score
Time frame: 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.
4 secondary outcomes
Operative Time
Time frame: Intraoperative
Duration of Postoperative Hospital Stay
Time frame: DAY 1 TO DAY 15
Incidence of Surgical Site Occurrences (SSOs)
Time frame: Within 30 days post-surgery
Time to Return to Normal Activities
Time frame: Within 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavita Sijwali, MBBS, MS SURGERY RESIDENT principal investigator
GSVM MEDICAL COLLEGE KANPUR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eTEP-RS Hernia Repair and IPOM Plus Hernia Repair in people with Ventral Hernia Repair and Abdominal Hernia, run by GSVM Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence Rate (time frame: Up to 6 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.