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

• Sponsor: Algemeen Ziekenhuis Maria Middelares (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05575141
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 74

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventral Incisional Hernia	Procedure: Component separation (transversus abdominis release)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: An open-label multicenter international European randomized controlled trialAn open-label multicenter international European randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: an Open-label Multicenter International Randomized Controlled Trial
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Mar 1, 2029

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Length of postoperative hospital stay [From date of operation until the date of discharge, assessed up to 20 days]

   Length of postoperative hospital stay

Secondary Outcome Measures

1. Skin-to-skin operative time [Per-operative (minutes)]

   Skin-to-skin operative time

2. Conversion rate [Per-operative]

   Conversion rate

3. Postoperative complication rate [30 days]

   Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions

4. Readmission and reoperation rate [30 Days]

   Readmission and reoperation rate

5. Post-anesthetic discharge scoring system [Immediately after the surgery]

   Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.

6. Postoperative visual analogue scale pain score [Immediately after the surgery]

   Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.

7. 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.

8. Body image score [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).

9. Hernia recurrence [3 Months, 12 months, 24 months, 60 months]

   Hernia recurrence

10. Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence [3 Months, 12 months, 24 months, 60 months]

    Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Algemeen Ziekenhuis Maria Middelares

Investigators

• Principal Investigator: Filip Muysoms, MD PhD, Clinical research center Maria Middelares

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Filip Muysoms, Head of General Surgery, Algemeen Ziekenhuis Maria Middelares
• ClinicalTrials.gov Identifier: NCT05575141
• Other Study ID Numbers: ROCSTAR
• First Posted: Oct 12, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia; Incisional Hernia; Hernia, Abdominal; Hernia, Ventral; Internal Hernia

Study Results

No Results Posted as of Oct 12, 2022