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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventral Hernia; Abdominal Wall Defect; Incisional Hernia
• Intervention / Treatment: Procedure: Robotically-assisted ventral hernia repair (RVHR); Procedure: Open ventral hernia repair (OVHR)

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiorenzo Angehrn, MD; Phone Number: 00 41 61 777 73 17; Email: fiorenzo.angehrn@clarunis.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotically-assisted ventral hernia repair (RVHR)	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 suture of the posterior rectus sheath and peritoneum, as appropriate. Synthetic retromuscular mesh placement with a mesh-size as large as the prepared surface allows. Closure of the anterior rectus sheath with absorbable barbed running suture. Port extraction, skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.
Active Comparator: Open ventral hernia repair (OVHR)	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 group. Retromuscular synthetic mesh placement with a mesh-size as far as the prepared surface allows. Mesh fixation optional with either absorbable sutures to the posterior sheath or with glubran glue. Closure of the anterior rectus sheath with a slowly-absorbable running suture. Skin closure. Dressing from xyphoid to pubis and 6 lateral dressings for blinding purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome: length of stay	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive complication index (CCI)	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).	30 days
Adverse events	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.	30 days
pain after surgery	- 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.	5 years
Functional recovery	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.	5 years
Quality of life using SF-12 form	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.	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: St. Clara Hospital, Basel, Switzerland; Klinikum Kempten, Kempten, Germany
• Investigators: Principal Investigator: Johannes Baur, MD, Clarunis - Universitäres Bauchzentrum Basel; Principal Investigator: Julian Süsstrunk, MD, Clarunis - Universitäres Bauchzentrum Basel

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia, Abdominal; Incisional Hernia; Hernia; Hernia, Ventral
• Other Study ID Numbers: 12032024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual patient data (IPD) may be shared upon reasonable request. If IPD is shared, data will be anonymised completely.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No