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NCT05423574 Clinical Trial

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

Ventral Hernia Clinical Trial

— r-TARUP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05423574
Other study ID # 2021PI130
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date March 1, 2022

Study information
Verified date August 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - major patients undergoing a robotic-assisted laparoscopy procedure for the treatment of ventral hernia repair Exclusion Criteria: - patient minor

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• robotic Trans Abdomino Pre Peritoneal prothesis repair
The treatment of primary and incisional ventral hernia using the robotic assisted laparoscopy technique

Locations
Country Name City State
France Centre Hospitalier Régional Universitaire (CHRU) Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate at 6 months Evaluated by clinical examination 6 months
Secondary Post operative pain Evaluated by a digital scale, from 0 (no pain) to 10 (maximal pain imaginable) 6 months
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