oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias

NCT ID: NCT06364306

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2031-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robotically-assisted ventral hernia repair (RVHR)

Group Type: EXPERIMENTAL

Robotically-assisted ventral hernia repair (RVHR)

Intervention Type: 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.

Open ventral hernia repair (OVHR)

Group Type: ACTIVE_COMPARATOR

Open ventral hernia repair (OVHR)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Clara Hospital, Basel, Switzerland

UNKNOWN

Sponsor Role: collaborator

Klinikum Kempten, Kempten, Germany

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Baur, MD

Role: PRINCIPAL_INVESTIGATOR

Clarunis - Universitäres Bauchzentrum Basel

Julian Süsstrunk, MD

Role: PRINCIPAL_INVESTIGATOR

Clarunis - Universitäres Bauchzentrum Basel

Central Contacts

Fiorenzo Angehrn, MD

Role: CONTACT

fiorenzo.angehrn@clarunis.ch

00 41 61 777 73 17

Other Identifiers

12032024

Identifier Type: -

Identifier Source: org_study_id