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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

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