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Recruiting NCT06364306

oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

No phase Interventional Ventral Hernia Incisional Hernia Abdominal Wall Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotically-assisted ventral hernia repair (RVHR), Open ventral hernia repair (OVHR).
Who it may be relevant to
Registry conditions: Ventral Hernia, Incisional Hernia, Abdominal Wall Defect. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - the PRIOR Multicentre Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure Robotically-assisted ventral hernia repair (RVHR)
    3 8mm robotic trocars are placed intraabdominally and the DaVinci Xi-robotic system is docked. Adhesiolysis from any adherent structures to the abdominal wall is performed. Incision of the lateral verge of the retromuscular space and retromuscular dissection. Superior and inferior cross-over to the contralateral retromuscular space and dissection of the hernia sac. Unilateral or bilateral transversus abdominis release (TAR) is performed, if necessary. Running suture with absorbable barbed sutur
  • Procedure Open ventral hernia repair (OVHR)
    Median laparotomy with a minimal length of the previous scar (in case of incisional hernia) and adhesiolysis is performed, where necessary, to liberate the abdominal wall and the ventral hernia from adhesions. Bilateral dissection of the posterior rectus sheath under visualisation and sparing of the epigastric vessels and neurovascular bundles. Closure of the posterior rectus sheath with a slowly-absorbable running suture. Indication for a uni- or bilateral TAR identical to the intervention grou

Primary outcome measures

  • Primary outcome: length of stay [Time frame: 30 days]
Secondary outcome measures (5)
  • Comprehensive complication index (CCI) [Time frame: 30 days]
  • Adverse events [Time frame: 30 days]
  • pain after surgery [Time frame: 5 years]
  • Functional recovery [Time frame: 5 years]
  • Quality of life using SF-12 form [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Switzerland · 2 centers
  • University Hospital Basel — Basel
  • Spital Oberwallis, Visp — Visp
Germany · 1 center
  • Klinikum Kempten — Kempten (Allgäu)

Identifiers

NCT: NCT06364306 · 12032024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗