Clinical trial NCT05575141: Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)
Official title: Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: a Multicenter International Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Incisional Hernia
Abdominal Wall Hernia
Keywords: Abdominal Wall Hernia
robotic TAR (rTAR)
open TAR (oTAR)
transversus abdominis release (TAR)
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a multicenter international randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days
Secondary outcomes:
measure: Skin-to-skin operative time
timeFrame: Per-operative (minutes)
measure: Conversion rate
timeFrame: Per-operative
measure: Surgical site related complications
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 Days and 3 months postoperative
measure: Post-anesthetic discharge scoring system
timeFrame: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
measure: Postoperative visual analogue scale pain score
timeFrame: From the end of surgery (last skin suture) until discharge, assessed up to 20 days
measure: EuraHS Quality of Life Scoring
timeFrame: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
measure: Body Image Scale
timeFrame: Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
measure: Hernia recurrence
timeFrame: 30 days, 3 Months, 12 months, 24 months, 60 months
measure: Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
timeFrame: 30 days, 3 Months, 12 months, 24 months, 60 months
measure: Postoperative complications
timeFrame: 30 days
measure: Reoperation rate
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Clinical research center Maria Middelares
name: Filip Muysoms, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: