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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • incisional hernia repair

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: rTARActive comparator 1 intervention
Group B: oTARActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of postoperative hospital stay

Length of postoperative hospital stay

Time frame
hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days

Secondary outcomes

1

Skin-to-skin operative time

Skin-to-skin operative time from first incision until last skin suture

Time frame
Per-operative (minutes)
2

Conversion rate

Conversion rate from the robotic-assisted approach to the open approach

Time frame
Per-operative
3

Surgical site related complications

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

Time frame
30 days
4

Readmission rate

Readmission rate

Time frame
30 Days and 3 months postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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