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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.


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


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
single port surgery
Single port surgery can be converted in multiport surgery if necessary
Multiport surgery


Locations

Country Name City State
France Service de Chirurgie Colorectale Clichy Ile De France

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

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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