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

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: an Open-label 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: Ventral Incisional Hernia
• Intervention / Treatment: Procedure: Component separation (transversus abdominis release)

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

Contacts and Locations

• Study Contact: Name: Maaike Vierstraete, MD; Phone Number: +3292467400; Email: maaikevierstraete@icloud.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

- All patients with a ventral incisional hernia of more than 8 centimeters in width

Exclusion Criteria:

• Emergency surgery
• Pregnancy
• Age<18
• Incisional hernia repair after open abdomen or enterocutaneous fistula
• Active wound infection
• Previous anterior or posterior component separation
• Absence of a signed informed consent
• Patients unable to give informed consent or complete the quality-of-life assessment (due to language barriers or intellectual capacity)
• Primary ventral hernias

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: Robotic-assisted repair of wide ventral incisional hernia; Robotic	Procedure: Component separation (transversus abdominis release); Component separation by transversus abdominis release, to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias.
Active Comparator: Open repair of wide ventral incisional hernia; Open	Procedure: Component separation (transversus abdominis release); Component separation by transversus abdominis release, to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large 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	From date of operation until the date of discharge, assessed up to 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin-to-skin operative time	Skin-to-skin operative time	Per-operative (minutes)
Conversion rate	Conversion rate	Per-operative
Postoperative complication rate	Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions	30 days
Readmission and reoperation rate	Readmission and reoperation rate	30 Days
Post-anesthetic discharge scoring system	Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.	Immediately after the surgery
Postoperative visual analogue scale pain score	Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.	Immediately after the surgery
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 score	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	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	3 Months, 12 months, 24 months, 60 months

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 (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): March 1, 2029

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): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia; Incisional Hernia
• 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