NCT05320055

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

April 1, 2022

Last Update Submit

August 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • epidural blockade or TAP block

    postoperative pain requiring epidural or TAP block

    0-1 postoperative day

Secondary Outcomes (2)

  • readmissison

    30 days

  • complications

    30 days

Study Arms (2)

IPOM

receiving laparoscopic intraperitoneal onlay mesh repair

Procedure: robotic repair

rTARUP

recieving robotic assited retromuscular repair

Procedure: robotic repair

Interventions

robotic assisted retromuscular hernia repair

IPOMrTARUP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • open repairs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 1650, Denmark

Location

Related Publications (1)

  • Christoffersen MW, Jorgensen LN, Jensen KK. Less postoperative pain and shorter length of stay after robot-assisted retrorectus hernia repair (rRetrorectus) compared with laparoscopic intraperitoneal onlay mesh repair (IPOM) for small or medium-sized ventral hernias. Surg Endosc. 2023 Feb;37(2):1053-1059. doi: 10.1007/s00464-022-09608-w. Epub 2022 Sep 15.

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mette Willaume, phd

    University of Copenhagen, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff specialist, MD, PhD

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 11, 2022

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations