TRUE: Single Port Colic Laparoscopic Surgery

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01959087

Collaborator

Fondation de l'Avenir (Other)

128

Enrollment

Location

Arms

37.8

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms Crohn's Disease Diverticulitis	Procedure: single port surgery Procedure: Multiport surgery	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

Actual Study Start Date :

Jan 27, 2014

Actual Primary Completion Date :

Feb 24, 2017

Actual Study Completion Date :

Mar 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1: Single port surgery Surgery with single port	Procedure: single port surgery Single port surgery can be converted in multiport surgery if necessary Procedure: Multiport surgery
Active Comparator: 2: Multiport surgery Surgery with multiport	Procedure: Multiport surgery

Arm

Intervention/Treatment

Experimental: 1: Single port surgery

Surgery with single port

Procedure: single port surgery

Single port surgery can be converted in multiport surgery if necessary

Procedure: Multiport surgery

Active Comparator: 2: Multiport surgery

Surgery with multiport

Procedure: Multiport surgery

Outcome Measures

Primary Outcome Measures

Length of postoperative hospital stay [30 days]
Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge

Secondary Outcome Measures

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;
Post-operative morbidity [Day 30]
Conversion rates [Day 1]
Pathologic results [Day 180]
Postoperative recovery [30 days]
Postoperative pain [6 days]
Aesthetic results [180 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18
Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
Informed consent signed
Social Insurance