Colonic Neoplasms, Crohn's Disease, Diverticulitis
Conditions
Keywords
Single port surgery, Colonic surgery, Postoperative morbidity, Postoperative outcomes
Brief summary
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.
Detailed description
The aim of this study is to compare surgical results of colonic resection performed by single port and multiport laparoscopic approaches. Primary endpoint is the length of postoperative hospital stay. Secondary endpoints include postoperative mortality, postoperative morbidity, conversion rates, postoperative recovery, aesthetic results, postoperative pain, and costs
Interventions
PROCEDUREsingle port surgery
Single port surgery can be converted in multiport surgery if necessary
PROCEDUREMultiport surgery
Sponsors
Fondation de l'Avenir
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative hospital stay | 30 days | Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative morbidity | Day 30 | — |
| Conversion rates | Day 1 | — |
| Pathologic results | Day 180 | — |
| Postoperative recovery | 30 days | — |
| Postoperative pain | 6 days | — |
| Operative mortality | 30 days | 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; |
| Costs | Day 180 | — |
| Lenght of true hospitalization stay | 30 days | — |
| Technical feasability | Day 1 | — |
| Post-operative quality of life | Day 180 | SF-36 and GIQLI |
| Aesthetic results | 180 days | — |
Countries
France
Outcome results
None listed