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NCT Number: NCT05195957

Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair

This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Maria Middelares, Ghent, Belgium

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About this study

Consecutive patients who undergo bilateral TAR in the treatment of their ventral incisional hernia in two European hernia centers are included in the study. A retrospective analysis of a prospectively maintained database and electronic patient files will be performed. Primary endpoint of the study was length of postoperative hospital stay. Secondary endpoints are intraoperative complications, in-hospital complications, overall and surgical site related complications during the first 30 postoperative days, overall and surgical site related complications during the reported follow-up period, and hernia recurrence during the reported follow-up period.

Data on the following variables wlll be collected.

  • Patient characteristics: age, sex, body-mass index (BMI), comorbidities, smoking habits, previous hernia repair and hernia dimensions
  • Intraoperatively: skin-to-skin operative time, wound contamination class (according to the center for disease control and prevention (CDC) classification)15, administration of antibiotics, mesh type used, mesh size, closure of the hernia defect, combined surgical procedures and intraoperative complications.
  • Postoperatively at discharge: length of postoperative hospital stay and in-hospital complications.
  • Postoperatively at 30 days after surgery: overall (according to the Clavien-Dindo classification)16 and surgical site related complications17, readmission rates during the first 30 days after surgery.
  • During follow-up: duration of reported follow-up, reoperation rates and hernia recurrences during the reported follow-up period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.

Exclusion criteria

  • unilateral transversus abdominis release
  • patients with a stoma or parastomal hernia

Treatment and study plan

Robotic tranversus abdominis release operation

Procedure

Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.

Open transversus abdominis release operation

Procedure

Original open TAR using midline incision.

Primary outcomes

  1. Length of postoperative hospital stay

    Time frame: immediately after the surgery

    Postoperative treatment and follow-up period in hospital

Secondary outcomes

  1. Complication rates

    Time frame: through study completion, an average of 1 year

    Postoperative complications during 30 days after surgery and longer follow-up

  2. Recurrence and reoperation rates

    Time frame: through study completion, an average of 2 year

    Postoperative recurrence of hernia and possible reoperations for recurrence

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Algemeen Ziekenhuis Maria Middelares

Registry information

Official study title

Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair A Retrospective Multicenter Case-control Study

Acronym: EUROTAR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

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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