NCT05939206

Brief Summary

The aim of the study is to assess the recurrence rate and potential long-term complications, at least 48 months, after a robotic assisted transabdominal retromuscular approach (rTARUP technique) for the repair of an umbilical hernia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

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

April 22, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

July 3, 2023

Last Update Submit

April 10, 2025

Conditions

Umbilical HerniaTARUPRobotic Abdominal Wall Surgery

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

    Hernia recurrence

    After at least 48 months post-operative

Secondary Outcomes (2)

  • Long-term complications

    After 48 months post-operative

  • Quality of Life Questionnaire

    After 48 months post-operative

Interventions

rTARUPPROCEDURE

robotic assisted transabdominal retromuscular umbilical prosthetic repair

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that underwent rTARUP procedure in the period September 2016 - December 2019

You may qualify if:

  • Patients that underwent rTARUP procedure in the period September 2016 - December 2019
  • Lateral approach to the retromuscular plane/lateral single docking
  • Use of Progrip self-fixating mesh

You may not qualify if:

  • Ventral hernia on the lateral side or combined hernia (lateral and medial)
  • eTEP approach to the retromuscular plane
  • Use of any other mesh than Progrip self-fixating mesh.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

April 22, 2023

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations

BE(1)