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

University of Oulu

Status: Completed

Conditions: Abdominal Wall Hernia

Treatments: Procedure: Robotic tranversus abdominis release operation; Procedure: Open transversus abdominis release operation

Study type: Observational

Funder types: Other

Identifiers

NCT05195957

12/2021

Details and patient eligibility

About

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).

Full 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.

Enrollment: 169 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

169 participants in 2 patient groups

rTAR

Description:

All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.

Treatment:

Procedure: Robotic tranversus abdominis release operation

oTAR

Description:

All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.

Treatment:

Procedure: Open transversus abdominis release operation