An observational study in Abdominal Wall Hernia, sponsored by University of Oulu. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2022-01-19.
Sponsored by University of Oulu · Observational
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).
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's enrollment of 169 is above the median of 115 across 29 observational studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.
Original open TAR using midline incision.
Length of postoperative hospital stay
Postoperative treatment and follow-up period in hospital
Time frame: immediately after the surgery
Complication rates
Postoperative complications during 30 days after surgery and longer follow-up
Time frame: through study completion, an average of 1 year
Recurrence and reoperation rates
Postoperative recurrence of hernia and possible reoperations for recurrence
Time frame: through study completion, an average of 2 year
Plan to share: Yes — All data is available for European Hernia Society researchers
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After results are published without any time limitations
Access criteria: When asked
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Oct 2021, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.