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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-17

Study Completion Date

2021-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Robotic Utility for Surgical Treatment of Umbilical Hernias

NCT02975414

Hernia, Umbilical

COMPLETED

Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair

NCT05320055

Hernia, Ventral

COMPLETED

rTARUP: Long-term Analysis

NCT05939206

Umbilical Hernia TARUP Robotic Abdominal Wall Surgery

COMPLETED

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall heRnias (ROCSTAR)

NCT05575141

Ventral Incisional Hernia Abdominal Wall Hernia

NOT_YET_RECRUITING NA

Transabdominal Preperitoneal Inguinal Hernia Repair

NCT05839587

Hernia, Inguinal Laparoscopy

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Wall Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

rTAR

All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.

Robotic tranversus abdominis release operation

Intervention Type PROCEDURE

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

oTAR

All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.

Open transversus abdominis release operation

Intervention Type PROCEDURE

Original open TAR using midline incision.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic tranversus abdominis release operation

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

Intervention Type PROCEDURE

Open transversus abdominis release operation

Original open TAR using midline incision.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.