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

NCT05195957 | Completed DMC

• 1 other identifier: 12/2021
• Study Type: observational
• Target: 169
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Abdominal Wall Hernia

Keywords

Abdominal wall surgery; Open surgery; Robotic surgery; Transversus abdominis release; Posterior component separation technique

Outcome Measures

Primary Outcomes (1)

• Length of postoperative hospital stay

  Postoperative treatment and follow-up period in hospital

  immediately after the surgery

Secondary Outcomes (2)

• Complication rates

  through study completion, an average of 1 year

• Recurrence and reoperation rates

  through study completion, an average of 2 year

Study Arms (2)

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

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

Interventions

Robotic tranversus abdominis release operation PROCEDURE

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

rTAR

Open transversus abdominis release operation PROCEDURE

Original open TAR using midline incision.

oTAR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oulu: lead
• Algemeen Ziekenhuis Maria Middelares: collaborator

Study Sites (2)

Hospital Maria Middelares

Ghent, 9000, Belgium

Location

Tero Rautio

Oulu, 90230, Finland

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 19, 2022
• Study Start: January 17, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 21, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After results are published without any time limitations
• Access Criteria: When asked

Locations

BE (1); FI (1)