Single Port Colic Laparoscopic Surgery

Crohn's Disease Clinical Trial

— TRUE  

Official title:

Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959087
• Other study ID #: P111112
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Crohn Disease
• Crohn's Disease
• Diverticulitis

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