oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias (PRIOR)

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University Hospital Basel

Status

Begins enrollment this month

Conditions

Incisional Hernia
Ventral Hernia
Abdominal Wall Defect

Treatments

Procedure: Open ventral hernia repair (OVHR)
Procedure: Robotically-assisted ventral hernia repair (RVHR)

Study type

Interventional

Funder types

Other

Identifiers

NCT06364306
12032024

Details and patient eligibility

About

This study investigates on the effect of two different operative techniques to treat large abdominal wall defects. The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR). The main questions it aims to answer are: length of stay after the operation rate of complications rate of recurrence and reoperations quality of life. Participants will: Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient age >18 years
  • Informed consent obtained
  • Transverse diameter of ventral hernia >4cm - 15cm
  • Eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment

Exclusion criteria

  • precedent hernia treatment with mesh placement in the retromuscular space
  • precedent anterior or posterior component separation or transversus abdominis release (TAR)
  • active wound infection
  • current cancer diagnosis
  • presence of ileostomy, colostomy or ileal conduit
  • liver disease defined by the presence of ascites
  • end-stage renal disease requiring dialysis
  • need of an emergency surgery
  • pregnancy

Criteria for participating surgeons Each participating surgeon has performed 20 or more OVHR and RVHR.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Robotically-assisted ventral hernia repair (RVHR)
Experimental group
Treatment:
Procedure: Robotically-assisted ventral hernia repair (RVHR)
Open ventral hernia repair (OVHR)
Active Comparator group
Treatment:
Procedure: Open ventral hernia repair (OVHR)

Trial contacts and locations

0

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Central trial contact

Fiorenzo Angehrn, MD

Data sourced from clinicaltrials.gov

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