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

January 13, 2022 updated by: University of Oulu

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Hospital Maria Middelares
  • Finland
      • Oulu, Finland, 90230
        • Tero Rautio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rTAR
All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.
Procedure: Robotic tranversus abdominis release operation
Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.
oTAR
All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.
Procedure: Open transversus abdominis release operation
Original open TAR using midline incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of postoperative hospital stay
Time Frame: immediately after the surgery
Postoperative treatment and follow-up period in hospital
immediately after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rates
Time Frame: through study completion, an average of 1 year
Postoperative complications during 30 days after surgery and longer follow-up
through study completion, an average of 1 year
Recurrence and reoperation rates
Time Frame: through study completion, an average of 2 year
Postoperative recurrence of hernia and possible reoperations for recurrence
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Algemeen Ziekenhuis Maria Middelares

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 17, 2021

Primary Completion (ACTUAL)

October 30, 2021

Study Completion (ACTUAL)

December 21, 2021

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (ACTUAL)

January 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data is available for European Hernia Society researchers

IPD Sharing Time Frame

After results are published without any time limitations

IPD Sharing Access Criteria

When asked

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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