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

Abdominal Wall Hernia Clinical Trial

— EUROTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195957
• Other study ID #: 12/2021
• Status: Completed
• Start date: January 17, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: January 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 21, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	Hospital Maria Middelares	Ghent
Finland	Tero Rautio	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Algemeen Ziekenhuis Maria Middelares

Countries where clinical trial is conducted

Belgium,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of postoperative hospital stay	Postoperative treatment and follow-up period in hospital	immediately after the surgery
Secondary	Complication rates	Postoperative complications during 30 days after surgery and longer follow-up	through study completion, an average of 1 year
Secondary	Recurrence and reoperation rates	Postoperative recurrence of hernia and possible reoperations for recurrence	through study completion, an average of 2 year