Single Port Colic Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Colonic Neoplasms; Crohn's Disease; Diverticulitis
• Interventions: Procedure: single port surgery; Procedure: Multiport surgery

• Registration Number: NCT01959087
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Study Start: 2014-01-27
• Primary Completion: 2017-02-24
• Study Completion: 2017-03-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Single port surgery	single port surgery	Surgery with single port
1: Single port surgery	Multiport surgery	Surgery with single port
2: Multiport surgery	Multiport surgery	Surgery with multiport

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Post-operative morbidity	Day 30
Pathologic results	Day 180
Costs	Day 180
Lenght of true hospitalization stay	30 days
Postoperative recovery	30 days
Aesthetic results	180 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;
Postoperative pain	6 days
Conversion rates	Day 1
Technical feasability	Day 1
Post-operative quality of life	Day 180	SF-36 and GIQLI

Trial Locations

Locations (1)

Service de Chirurgie Colorectale; 🇫🇷 Clichy, Ile De France, France