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Completed

NCT Number: NCT05939206

rTARUP: Long-term Analysis

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.

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Key information

Conditions

Umbilical Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Robotic Abdominal Wall Surgery TARUP

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares

Ghent, 9000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTARUP

Procedure

robotic assisted transabdominal retromuscular umbilical prosthetic repair

Primary outcomes

  1. Hernia recurrence

    Time frame: After at least 48 months post-operative

    Hernia recurrence

Secondary outcomes

  1. Long-term complications

    Time frame: After 48 months post-operative

    Long-term complications

  2. Quality of Life Questionnaire

    Time frame: After 48 months post-operative

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

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

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

Acronym: rTARUP FU

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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