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Clinical Trials/CTRI/2023/03/050605
CTRI/2023/03/050605Not yet recruitingNot Applicable

Extended view totally extraperitoneal Rives Stoppa (e-TEP RS) versus laparoscopic intraperitoneal onlay mesh (IPOM) plus repair for ventral hernia-A Randomized controlled study

Binit Sharma1 site in 1 country20 target enrollmentStarted: March 15, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Operative time defined from incision to last stitch between e-TEP RS versus IPOM plus

Study Overview

Brief Summary

Primary and incisional ventral hernias repairs have always been a challenge for surgeons. In the current era, so many different options for the management of these hernias are available from various open to minimal invasive techniques, and this diversity of techniques makes the decision making more difficult in ventral hernia. Surgeons are still in a search of the ideal or standardized method that adequately decreases postoperative complications and improves quality of life. According to latest evidence, laparoscopic techniques have the advantage of shorter hospital stay after surgery, early resumption of work, and lesser surgical wound complications as compared to open techniques. From IPOM to e-TEP, minimal invasive procedures for ventral hernia repair with different techniques and mesh positions have evolved rapidly in the last decade. e-TEP offers the benefit of a minimally invasive procedure along with mesh in sublay/retrorectus position, hence avoiding the intra-abdominal mesh-related complications. .Another advantage of e-TEP in large ventral hernia is that if closure is difficult or not possible, then posterior component separation technique in the form of transversus abdominis release can be combined as the plane of dissection is the same. As per available evidence, it is believed that mesh in sublay position offers superior quality of postoperative connective tissue formation, less recurrence, and less cost as compared to composite mesh with anti-adhesion barrier used for intra-peritoneal position. The current data are lacking, as till now only one retrospective comparative study by Penchev et al. of both the approaches has been published.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All cases of midline ventral hernia(M2,M3) in central or lower abdomen between age 18-75 years.

Exclusion Criteria

  • Patients with defect size > 6cm
  • Recurrent Hernias
  • Emergency cases
  • Hernia with skin infections and enterocutaneous fistula
  • BMI more than 35.

Outcomes

Primary Outcomes

Operative time defined from incision to last stitch between e-TEP RS versus IPOM plus

Time Frame: Duration of operation defined from incision to last stitch between e-TEP RS versus IPOM plus

Secondary Outcomes

  • 1. Postoperative pain using VAS score at 1day, 1week, 6 week postop(2. Duration of hospital stay(Days))

Investigators

Sponsor
Binit Sharma
Sponsor Class
Other [self]

Study Sites (1)

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