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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: robotic Trans Abdomino Pre Peritoneal prothesis repair

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Centre Hospitalier Régional Universitaire (CHRU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patient minor

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate at 6 months	Evaluated by clinical examination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	Evaluated by a digital scale, from 0 (no pain) to 10 (maximal pain imaginable)	6 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: robotic assisted laparoscopy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 2021PI130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No