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

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: a Multicenter International Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Wall Hernia; Ventral Incisional Hernia
• Intervention / Treatment: Procedure: incisional hernia repair

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maaike Vierstraete, MD; Phone Number: +3293329500; Email: maaikevierstraete@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: rTAR; 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; Incisional hernia repair for the treatment of wide ventral incisional hernias.
Active Comparator: oTAR; 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; Incisional hernia repair for the treatment of wide ventral incisional hernias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation rate	Reoperation rate	30 days
Skin-to-skin operative time	Skin-to-skin operative time from first incision until last skin suture	Per-operative (minutes)
Conversion rate	Conversion rate from the robotic-assisted approach to the open approach	Per-operative
Surgical site related complications	Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions	30 days
Readmission rate	Readmission rate	30 Days and 3 months postoperative
Post-anesthetic discharge scoring system	Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.	From the end of surgery (last skin suture) until discharge, assessed up to 20 days
Postoperative visual analogue scale pain score	Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.	From the end of surgery (last skin suture) until discharge, assessed up to 20 days
EuraHS Quality of Life Scoring	Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome.	Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Body Image Scale	Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).	Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
Hernia recurrence	Hernia recurrence	30 days, 3 Months, 12 months, 24 months, 60 months
Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence	Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence	30 days, 3 Months, 12 months, 24 months, 60 months
Postoperative complications	Postoperative complications classified acoording to the Clavien-Dindo Classification	30 days

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares
• Investigators: Principal Investigator: Filip Muysoms, MD PhD, Clinical research center Maria Middelares

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Abdominal Wall Hernia; robotic TAR (rTAR); open TAR (oTAR); transversus abdominis release (TAR)
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Internal Hernia; Incisional Hernia; Hernia; Hernia, Abdominal; Hernia, Ventral
• Other Study ID Numbers: ROCSTAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No