Clinical trial NCT05195957: Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair
Official title: Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair A Retrospective Multicenter Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Wall Hernia
Keywords: Abdominal wall surgery
Open surgery
Robotic surgery
Transversus abdominis release
Posterior component separation technique
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Algemeen Ziekenhuis Maria Middelares
First posted: 2022-01-19
Enrollment: 169
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Complication rates
timeFrame: through study completion, an average of 1 year
measure: Recurrence and reoperation rates
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Hospital Maria Middelares
city: Oulu
country: Finland
facility: Tero Rautio
Study officials:
References: