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

Abdominal Wall Hernia Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Abdominal Wall Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia

• NCT number: NCT05195957
• Study type: Observational [Patient Registry]
• Source: University of Oulu
• Status: Completed
• Start date: January 17, 2021
• Completion date: December 21, 2021