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

Completed

• Conditions: Abdominal Wall Hernia
• Interventions: Procedure: Robotic tranversus abdominis release operation; Procedure: Open transversus abdominis release operation

• Registration Number: NCT05195957
• Lead Sponsor: University of Oulu

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).

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 Timeline

• Study Start: 2021-01-17
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-21
• Study First Submitted: 2021-12-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rTAR	Robotic tranversus abdominis release operation	All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.
oTAR	Open transversus abdominis release operation	All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.

Primary Outcome Measures

Name	Time	Method
Length of postoperative hospital stay	immediately after the surgery	Postoperative treatment and follow-up period in hospital

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Tero Rautio; 🇫🇮 Oulu, Finland

Hospital Maria Middelares; 🇧🇪 Ghent, Belgium