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

Algemeen Ziekenhuis Maria Middelares

Status: Begins enrollment this month

Conditions: Abdominal Wall Hernia; Ventral Incisional Hernia

Treatments: Procedure: incisional hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05575141

ROCSTAR

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

rTAR

Active Comparator group

Description:

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.

Treatment:

Procedure: incisional hernia repair

oTAR

Active Comparator group

Description:

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.

Treatment:

Procedure: incisional hernia repair