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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Wall Hernia

Intervention / Treatment
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* Procedure: Robotic tranversus abdominis release operation
* Procedure: Open transversus abdominis release operation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rTAR<br>All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion. | Procedure: Robotic tranversus abdominis release operation<br>* Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.<br>|
| oTAR<br>All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion. | Procedure: Open transversus abdominis release operation<br>* Original open TAR using midline incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | Postoperative treatment and follow-up period in hospital | immediately after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates | Postoperative complications during 30 days after surgery and longer follow-up | through study completion, an average of 1 year | 
| Recurrence and reoperation rates | Postoperative recurrence of hernia and possible reoperations for recurrence | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal wall surgery, Open surgery, Robotic surgery, Transversus abdominis release, Posterior component separation technique