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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2033-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Incisional Hernia Abdominal Wall Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a multicenter international randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

incisional hernia repair

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

incisional hernia repair

Intervention Type PROCEDURE

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

Interventions

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incisional hernia repair

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No