Crohn's Disease Clinical Trial
— TRUEOfficial title:
Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
NCT number | NCT01959087 |
Other study ID # | P111112 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 27, 2014 |
Est. completion date | March 24, 2017 |
Verified date | November 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.
Status | Completed |
Enrollment | 128 |
Est. completion date | March 24, 2017 |
Est. primary completion date | February 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 - Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis - Informed consent signed - Social Insurance Exclusion Criteria: - Digestive stoma in place or planned during the intervention - Body mass index > 30 kg/m2 - History of previous laparotomy, except Mc Burney, Pfannenstiel ou subcostal - Subtotal colectomy - Transverse colectomy - Proctectomy or total coloproctectomy - Synchronous metastasis - Preoperative suspicion of T4 colorectal cancer - Emergency procedure - Associated resection (except appendectomy or liver biopsy) - Pregnancy or current breast feeding. |
Country | Name | City | State |
---|---|---|---|
France | Service de Chirurgie Colorectale | Clichy | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Fondation de l'Avenir |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of postoperative hospital stay | Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge | 30 days | |
Secondary | Operative mortality | Operative mortality rate; Overall morbidity rate at 30 days postoperatively including infectious and noninfectious morbidity according to the DINDO classification; Rates of incisional herniation, occlusion, rehospitalization related to the surgical procedure and reintervention until J180; Actual hospital stay; | 30 days | |
Secondary | Post-operative morbidity | Day 30 | ||
Secondary | Conversion rates | Day 1 | ||
Secondary | Pathologic results | Day 180 | ||
Secondary | Postoperative recovery | 30 days | ||
Secondary | Postoperative pain | 6 days | ||
Secondary | Aesthetic results | 180 days | ||
Secondary | Costs | Day 180 | ||
Secondary | Lenght of true hospitalization stay | 30 days | ||
Secondary | Technical feasability | Day 1 | ||
Secondary | Post-operative quality of life | SF-36 and GIQLI | Day 180 |
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