Single Port Colic Laparoscopic Surgery (TRUE)

November 19, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Clichy, Ile De France, France, 92110
        • Service de Chirurgie Colorectale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of postoperative hospital stay
Time Frame: 30 days
Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative mortality
Time Frame: 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;
30 days
Post-operative morbidity
Time Frame: Day 30
Day 30
Conversion rates
Time Frame: Day 1
Day 1
Pathologic results
Time Frame: Day 180
Day 180
Postoperative recovery
Time Frame: 30 days
30 days
Postoperative pain
Time Frame: 6 days
6 days
Aesthetic results
Time Frame: 180 days
180 days
Costs
Time Frame: Day 180
Day 180
Lenght of true hospitalization stay
Time Frame: 30 days
30 days
Technical feasability
Time Frame: Day 1
Day 1
Post-operative quality of life
Time Frame: Day 180
SF-36 and GIQLI
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation de l'Avenir

Investigators

  • Principal Investigator: Yves PANIS, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2014

Primary Completion (Actual)

February 24, 2017

Study Completion (Actual)

March 24, 2017

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P111112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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