NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias
oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

NCT06364306

RecruitingNA

Sponsor: University Hospital, Basel, Switzerland

Conditions: Ventral Hernia, Incisional Hernia, Abdominal Wall Defect

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

Countries: Germany, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (3)
  • Kempten (Allgäu), Bavaria, Germany
  • Basel, Canton of Basel-City, Switzerland
  • Visp, Valais, Switzerland