rTARUP: Long-term Analysis

Completed

• Conditions: Umbilical Hernia; TARUP; Robotic Abdominal Wall Surgery

• Registration Number: NCT05939206
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

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 Timeline

• Study Start: 2023-04-22
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	After at least 48 months post-operative	Hernia recurrence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AZ Maria Middelares; 🇧🇪 Ghent, Belgium