NCT05423574

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

September 13, 2021

Last Update Submit

June 14, 2022

Conditions

Ventral Hernia

Keywords

robotic assisted laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate at 6 months

    Evaluated by clinical examination

    6 months

Secondary Outcomes (1)

  • Post operative pain

    6 months

Interventions

robotic Trans Abdomino Pre Peritoneal prothesis repairPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patient minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire (CHRU)

Nancy, 54000, France

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

June 21, 2022

Study Start

January 1, 2021

Primary Completion

July 1, 2021

Study Completion

March 1, 2022

Last Updated

June 21, 2022

Record last verified: 2021-08

Locations

FR(1)