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NCT Number: NCT05423574

Robotic Trans-Abdominal Retromuscular Umbilical Prosthesis (r-TARUP)

Combining the advantage of minimally invasive surgery with laparoscopy to reduce postoperative complications and the placement of a retromuscular prosthesis with closure of the defect in order to reduce the risk of adhesion and restore normal anatomy in the treatment of primary and incisional ventral hernias, is made possible through robotic assistance.

The challenge of this study concerns the evaluation of quality of life, postoperative pain and recurrence at 6 months in the management of primary and incisional ventral hernias by robot-assisted laparoscopic approach.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Régional Universitaire (CHRU)

Nancy, 54000, France

About this study

The robotic-assisted laparoscopic approach for the treatment of primary and secondary ventral hernias is already used in the visceral department of Nancy in France. This technique seems to reduce post operative pain, to improve quality of live and to reduce recurrence. The goal of the study is to evaluate the benefices of this technique. The quality of life, postoperative pain and recurrence will be evaluated at one and six months postoperatively. The recurrence will be evaluated by clinical examination and a computed tomography scan performed at sixth month postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • major patients undergoing a robotic-assisted laparoscopy procedure for the treatment of ventral hernia repair

Exclusion criteria

  • patient minor

Treatment and study plan

robotic Trans Abdomino Pre Peritoneal prothesis repair

Procedure

The treatment of primary and incisional ventral hernia using the robotic assisted laparoscopy technique

Primary outcomes

  1. Recurrence rate at 6 months

    Time frame: 6 months

    Evaluated by clinical examination

Secondary outcomes

  1. Post operative pain

    Time frame: 6 months

    Evaluated by a digital scale, from 0 (no pain) to 10 (maximal pain imaginable)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Feasibility Study of Robotic Trans-Abdominal Retromuscular Umbilical Prosthesis (r-TARUP) for the Treatment of Primary and Incisional Ventral Hernia

Acronym: r-TARUP

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

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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