Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .
In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.
Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:
The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs.
In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance <30ml/min).
The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh.
A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%).
The total duration of the study is 30 months (12 months of follow-up for each patient).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | robot-assisted coelioscopy |
|
| 2 | Active Comparator | conventional coelioscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic DA VINCI Robot Assisted coelioscopy | Device | Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the reduction in morphine consumption | during the postoperative 48h |
| Measure | Description | Time Frame |
|---|---|---|
| Pain patient (ENS, total consumption of morphine) | during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery | |
| quality of life (questionary SF-36) | 1 month, 6 month and 12 month of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claude Tayar | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Chenevier-Mondor | Créteil | 94000 | France |
Not provided
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| conventional coelioscopy | Procedure | Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate |
|
| length of stay in hospital, percentage return home to 24 hours of surgery | to 24 hours of surgery |
| morbidity | during the study |
| resumption of work | after surgery |