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NCT Number: NCT05575141

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

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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Key information

Conditions

Ventral Incisional Hernia Abdominal Wall Hernia Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incisional hernia repair

Procedure

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

Primary outcomes

  1. Length of postoperative hospital stay

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

    Length of postoperative hospital stay

Secondary outcomes

  1. Skin-to-skin operative time

    Time frame: Per-operative (minutes)

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

  2. Conversion rate

    Time frame: Per-operative

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

  3. Surgical site related complications

    Time frame: 30 days

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

  4. Readmission rate

    Time frame: 30 Days and 3 months postoperative

    Readmission rate

  5. Post-anesthetic discharge scoring system

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

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

  6. Postoperative visual analogue scale pain score

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

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

  7. EuraHS Quality of Life Scoring

    Time frame: 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 Scale

    Time frame: 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

    Time frame: 30 days, 3 Months, 12 months, 24 months, 60 months

    Hernia recurrence

  10. Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence

    Time frame: 30 days, 3 Months, 12 months, 24 months, 60 months

    Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence

  11. Postoperative complications

    Time frame: 30 days

    Postoperative complications classified acoording to the Clavien-Dindo Classification

  12. Reoperation rate

    Time frame: 30 days

    Reoperation rate

Study contacts

Contact information is provided by the study sponsor or research team.

Maaike Vierstraete, MD

CONTACT

[email protected]

+3293329500

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: a Multicenter International Randomized Controlled Trial

Acronym: ROCSTAR

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Oct 12, 2022
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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