Clinical trial NCT05939206: rTARUP: Long-term Analysis
Official title: rTARUP (Robotic-assisted Transabdominal Retromuscular Umbilical Prosthetic Repair): Long-term Analysis of More Than 48 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Hernia
TARUP
Robotic Abdominal Wall Surgery
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that underwent rTARUP procedure in the period September 2016 - December 2019

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hernia recurrence
timeFrame: After at least 48 months post-operative
Secondary outcomes:
measure: Long-term complications
timeFrame: After 48 months post-operative
measure: Quality of Life Questionnaire
timeFrame: After 48 months post-operative
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
References: