NCT05195957

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Wall Hernia

Interventions

Type	Name	Description
PROCEDURE	Robotic tranversus abdominis release operation	Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.
PROCEDURE	Open transversus abdominis release operation	Original open TAR using midline incision.

Timeline

• Start date: 2021-01-17
• Primary completion: 2021-10-30
• Completion: 2021-12-21
• First posted: 2022-01-19
• Last updated: 2022-01-19

Locations

2 sites across 2 countries: Belgium, Finland