rTARUP: Long-term Analysis

Umbilical Hernia Clinical Trial

— rTARUP FU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939206
• Other study ID #: rTARUP FU
• Status: Recruiting
• Start date: April 22, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Algemeen Ziekenhuis Maria Middelares
• Contact: Filip Muysoms, MD
• Phone: 092467400
• Email: filip.muysoms[@]azmmsj.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 203
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Umbilical
• Umbilical Hernia

Intervention

Procedure:
• rTARUP
robotic assisted transabdominal retromuscular umbilical prosthetic repair

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent
Belgium	AZ Maria Middelares	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Ziekenhuis Maria Middelares

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	Hernia recurrence	After at least 48 months post-operative
Secondary	Long-term complications	Long-term complications	After 48 months post-operative
Secondary	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