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CompletedNCT05939206rTARUP FUUpdated Apr 11, 2025

rTARUP: Long-term Analysis

An observational study in Umbilical Hernia, TARUP and Robotic Abdominal Wall Surgery, sponsored by Algemeen Ziekenhuis Maria Middelares. Completed at 2 sites in Belgium. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by Algemeen Ziekenhuis Maria Middelares · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Sex
All
01

Study 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.

Read the detailed description

The rTARUP technique (robotic assisted transabdominal retromuscular umbilical prosthetic repair) has been introduced in the latest years for the treatment of ventral/umbilical hernias. Short-term analyses have proven that this technique can be performed safely and without complications. The technique maintains the benefits of a traditional laparoscopic approach (smaller incision, faster recovery, shorter hospital stay) and obeys mesh complications related to intraperitoneal mesh placement (adhesions, pain due to mesh fixation). An initial evaluation was conducted at our center to assess recurrence and complications 1 year after the procedure in a patient group of 203 patients. We documented 3 patients with a recurrence of which 2 of them had a laparoscopic intra-peritoneal hernia repair to treat the recurrence. Due to Covid-19 restrictions a clinical follow-up was only possible in 73% of patients. Therefore, we believe that a longer follow-up period of at least 48 months after surgery is necessary and surgically relevant to analyze the primary (recurrence rate) and secondary (long-term complications) end points of the recently introduced rTARUP technique for the treatment of ventral/umbilical hernias.

Muysoms, F., et al., Robotic transabdominal retromuscular umbilical prosthetic hernia repair (TARUP): observational study on the operative time during the learning curve. Hernia, 2018. 22(6): p. 1101-1111.

Muysoms, F., et al., Observational study with one year follow-up on robotic assisted retro-rectus ventral hernia repair (RTARUP) with a self-fixating mesh. Br J Surg, 2021. 108(Suppl 8).

02

Conditions studied

  • Umbilical Hernia
  • TARUP
  • Robotic Abdominal Wall Surgery

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03

In context

Hernia, Umbilical

67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.

This study's enrollment of 111 is close to the median of 118 across 25 observational studies indexed under Hernia, Umbilical.

Browse Hernia, Umbilical studies →

Lead sponsor

Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No

Interventions

  • ProcedurerTARUP

    robotic assisted transabdominal retromuscular umbilical prosthetic repair

06

What researchers measure

Primary outcomes

  1. Hernia recurrence

    Hernia recurrence

    Time frame: After at least 48 months post-operative

Secondary outcomes

  1. Long-term complications

    Long-term complications

    Time frame: After 48 months post-operative

  2. Quality of Life Questionnaire

    Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome

    Time frame: After 48 months post-operative

07

Study locations

2 sites
  • AZ Maria Middelares
    Gent, 9000, Belgium
  • AZ Maria Middelares
    Ghent, 9000, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in Dec 2024, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2023
First posted
Jul 11, 2023
StartActual
Apr 22, 2023
Primary completionActual
Dec 20, 2024
CompletionActual
Dec 20, 2024
Last update
Apr 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05939206
Lead sponsor
Algemeen Ziekenhuis Maria Middelares
Responsible party
Filip Muysoms (MD, Algemeen Ziekenhuis Maria Middelares) — Principal investigator
First posted
Jul 11, 2023
Start date
Apr 22, 2023
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Last update
Apr 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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