oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

Not Applicable

Not yet recruiting

• Conditions: Ventral Hernia; Incisional Hernia; Abdominal Wall Defect
• Interventions: Procedure: Robotically-assisted ventral hernia repair (RVHR); Procedure: Open ventral hernia repair (OVHR)

• Registration Number: NCT06364306
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Study Start: 2025-10-01
• Primary Completion: 2027-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotically-assisted ventral hernia repair (RVHR)	Robotically-assisted ventral hernia repair (RVHR)	-
Open ventral hernia repair (OVHR)	Open ventral hernia repair (OVHR)	-

Primary Outcome Measures

Name	Time	Method
Primary outcome: length of stay	30 days	Length of stay Length of stay is defined as the time from the operation until patient discharge is feasible according to the following criteria: * pain on numeric rating scale (NRS) \< 4 without opioid use; * tolerance of oral food intake without nausea / vomiting; * no signs of surgical site occurrence (SSO) or other postoperative complications; * no drains in place; * autonomy in daily living activities

Secondary Outcome Measures

Name	Time	Method
pain after surgery	5 years	- Pain, measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a after 7days, 30 days, 6 months, 1, 3 and 5 years.; The range fro the PROMIS ranges from 3 (no pain) to maximum of 15 (very severe pain) points.
Adverse events	30 days	* Intraoperative adverse events (bleeding, conversion rate, injury to bowel structures); * Postoperative adverse events (all other than surgical site occurrences such as ileus, pulmonary embolism, pneumonia, etc.) according to Clavien-Dindo Classification up to 30 days after surgery.
Comprehensive complication index (CCI)	30 days	According to Slankamenac K, Graf R, Barkun J, Clavien P. The Comprehensive Complication Index. Ann Surg. 2013;258 The CCI ranges from 0 (no complications) to maximum 100 (death of the patient).
Functional recovery	5 years	Functional recovery measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire.; The questionnaire uses 5 questions describing the patients health and abilities on that particular day and a visual analogue scale question (0 = worst, 100 = best) on the patients health on that particular day.
Quality of life using SF-12 form	5 years	The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36).; Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12).; The score ranges from 0 - 100, with a higher score indicating better physical and mental health functioning.