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

Not Applicable

Not yet recruiting

• Conditions: Ventral Incisional Hernia; Abdominal Wall Hernia
• Interventions: Procedure: incisional hernia repair

• Registration Number: NCT05575141
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Start: 2025-07-01
• Primary Completion: 2028-01-01
• Study Completion: 2033-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTAR	incisional hernia repair	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.
oTAR	incisional hernia repair	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.

Primary Outcome Measures

Name	Time	Method
Length of postoperative hospital stay	hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days	Length of postoperative hospital stay

Secondary Outcome Measures

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