oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

NCT06364306 | Not Yet Recruiting DMC

• 1 other identifier: 12032024
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ventral Hernia; Incisional Hernia; Abdominal Wall Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comprehensive complication index (CCI)

  30 days

• Adverse events

  30 days

• pain after surgery

  5 years

• Functional recovery

  5 years

• Quality of life using SF-12 form

  5 years

Study Arms (2)

Robotically-assisted ventral hernia repair (RVHR)

EXPERIMENTAL

Procedure: Robotically-assisted ventral hernia repair (RVHR)

Open ventral hernia repair (OVHR)

ACTIVE COMPARATOR

Procedure: Open ventral hernia repair (OVHR)

Interventions

Robotically-assisted ventral hernia repair (RVHR) PROCEDURE

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.

Robotically-assisted ventral hernia repair (RVHR)

Open ventral hernia repair (OVHR) PROCEDURE

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.

Open ventral hernia repair (OVHR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• St. Clara Hospital, Basel, Switzerland: collaborator
• Klinikum Kempten, Kempten, Germany: collaborator

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Johannes Baur, MD

  Clarunis - Universitäres Bauchzentrum Basel

  PRINCIPAL INVESTIGATOR

• Julian Süsstrunk, MD

  Clarunis - Universitäres Bauchzentrum Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiorenzo Angehrn, MD

CONTACT

00 41 61 777 73 17; fiorenzo.angehrn@clarunis.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are blinded to their treatment allocation until hospital discharge criteria according to the primary endpoint are fulfilled. After discharge, blinding is difficult to be ensured because there is no control, if dressing have been removed or modified. To ensure patient blinding during hospital stay, patients from both treatment arms will receive identical dressings as if an open and minimal-invasive access had been performed. In case the dressing must be changed during the hospital stay, this will be performed while the patient is blinded using a cover. In case for any reason the patient has been unblinded to his treatment allocation (accidental or intentional dressing removal, bed-side wound opening, other) all outcome data are assessed regardless and unblinding is documented and reported in the final report.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 15, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 18, 2025

Record last verified: 2025-04