Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair (TAR-POM)

August 4, 2023 updated by: Mette Willaume, Bispebjerg Hospital

Less Postoperative Pain and Length of Stay After Robotic-assisted Laparoscopic Transabdominal Repair With Retro Rectus Mesh Placement (rTARUP) Compared With Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for Small and Medium-sized Ventral Hernias

Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1650
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population is all patients referred from primary sector and eligible for laparoscopic primary ventral or incisional hernia repair

Description

Inclusion Criteria:

  • all patients undergoing elective minimally invasive repair for small or medium-sized primary ventral or incisional hernia repairs at one academic hernia center with an unrestricted patient referral.

Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).

Exclusion Criteria:

  • open repairs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IPOM
receiving laparoscopic intraperitoneal onlay mesh repair
Procedure: robotic repair
robotic assisted retromuscular hernia repair
rTARUP
recieving robotic assited retromuscular repair
Procedure: robotic repair
robotic assisted retromuscular hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
epidural blockade or TAP block
Time Frame: 0-1 postoperative day
postoperative pain requiring epidural or TAP block
0-1 postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
readmissison
Time Frame: 30 days
if the patients get readmitted during the follow-up
30 days
complications
Time Frame: 30 days
if the patients get any medical or surgical complication during the follow-up
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Mette Willaume, phd, University of Copenhagen, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPOM vs TARUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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