Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)

NCT05575141 | Not Yet Recruiting

• 1 other identifier: ROCSTAR
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

Conditions

Ventral Incisional Hernia; Abdominal Wall Hernia

Keywords

Abdominal Wall Hernia; robotic TAR (rTAR); open TAR (oTAR); transversus abdominis release (TAR)

Outcome Measures

Primary Outcomes (1)

• Length of postoperative hospital stay

  Length of postoperative hospital stay

  hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days

Secondary Outcomes (12)

• Skin-to-skin operative time

  Per-operative (minutes)

• Conversion rate

  Per-operative

• Surgical site related complications

  30 days

• Readmission rate

  30 Days and 3 months postoperative

• Post-anesthetic discharge scoring system

  From the end of surgery (last skin suture) until discharge, assessed up to 20 days

Study Arms (2)

rTAR

ACTIVE COMPARATOR

Patients randomized in the robotic group will undergo the technique for intra-and perioperative management for robotic complex abdominal wall repair cases as used in the center. A robotic surgical platform (da Vinci X or da Vinci Xi Surgical System, Intuitive Surgical, Aubonne, Switzerland) will be used and a retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference.

Procedure: incisional hernia repair

oTAR

ACTIVE COMPARATOR

Patients randomized in the open group will undergo the technique for intra-and perioperative management for open complex abdominal wall repair cases as used in the center. A retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference.

Procedure: incisional hernia repair

Interventions

incisional hernia repair PROCEDURE

Incisional hernia repair for the treatment of wide ventral incisional hernias.

oTAR; rTAR

Eligibility Criteria

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

You may qualify if:

• \- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)

You may not qualify if:

• Pregnant or suspected pregnancy
• Not-curatively treated malignancy, with life expectancy less than 24 months
• Patients unable to give informed consent or complete study specific questionnaires
• Emergency surgery
• Primary ventral hernia repair
• Exclusively lateral hernias not involving the midline
• Incisional hernia repair after open abdomen or enterocutaneous fistula
• Active wound infection
• Previous anterior or posterior component separation
• Patients with an existing ostomy
• Patients with a life expectancy of less than 24 months
• Patients suspected of being unable to comply with the study protocol

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Muysoms, MD PhD

  Clinical research center Maria Middelares

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maaike Vierstraete, MD

CONTACT

+3293329500; maaikevierstraete@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label Randomized Controlled Trial (RCT) where the patient, surgeon, research coordinators and hospital staff will be aware of the treatment arm after randomization. As the open approach is performed using a large midline incision, whereas the robotic approach applies only 6 or 7 small incisions (or less if no posterior component separation is needed), blinding of patients and physicians is difficult. Evaluation of the radiographic imaging of the abdominal wall at 24 months (MRI or CT scan) will be done by radiologists at the local participating center blinded to the randomized treatment arm. This will be a blinded evaluation for the presence or absence of hernia recurrence. Data analysis will be performed in a blinded manner by an independent statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of General Surgery

Model Details: a multicenter international randomized controlled trial

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: October 12, 2022
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2033
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share