rTARUP: Long-term Analysis (rTARUP FU)

rTARUP (Robotic-assisted Transabdominal Retromuscular Umbilical Prosthetic Repair): Long-term Analysis of More Than 48 Months

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.

Study Overview

• Status: Completed
• Conditions: Umbilical Hernia; TARUP; Robotic Abdominal Wall Surgery
• Intervention / Treatment: Procedure: rTARUP

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).

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Ghent, Belgium, 9000
    • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	Hernia recurrence	After at least 48 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term complications	Long-term complications	After 48 months post-operative
Quality of Life Questionnaire	Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome	After 48 months post-operative

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2023
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia; Hernia, Abdominal; Hernia, Ventral; Hernia, Umbilical
• Other Study ID Numbers: rTARUP FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No