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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05195957
Acronym
EUROTAR
Enrollment
169
Registered
2022-01-19
Start date
2021-01-17
Completion date
2021-12-21
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Wall Hernia

Keywords

Abdominal wall surgery, Open surgery, Robotic surgery, Transversus abdominis release, Posterior component separation technique

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.

Interventions

PROCEDURERobotic tranversus abdominis release operation

Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.

PROCEDUREOpen transversus abdominis release operation

Original open TAR using midline incision.

Sponsors

Algemeen Ziekenhuis Maria Middelares
CollaboratorOTHER
University of Oulu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of postoperative hospital stayimmediately after the surgeryPostoperative treatment and follow-up period in hospital

Secondary

MeasureTime frameDescription
Complication ratesthrough study completion, an average of 1 yearPostoperative complications during 30 days after surgery and longer follow-up
Recurrence and reoperation ratesthrough study completion, an average of 2 yearPostoperative recurrence of hernia and possible reoperations for recurrence

Countries

Belgium, Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026