Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)

November 17, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life

The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.

The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.

The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).

A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.

On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.

Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.

Study Type

Observational

Enrollment (Actual)

142

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
      • Paris, France, 75013
        • Pitie-Salpêtrière Hospital

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Right colon cancer < T4 without metastasis needing colectomy

Description

Inclusion Criteria:

  • Age ≥18 years old <= 80 years old
  • Right colon cancer < T4 without metastasis
  • <T4 N0M0

Exclusion Criteria:

  • Pregnant patient
  • T4 cancer
  • Metastasis

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

Cohorts and Interventions

Group / Cohort
1
laparoscopic surgery in right colon cancer operations
2
open surgery in right colon cancer operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost during the 2 postoperative years
Time Frame: during the 2 postoperative years
during the 2 postoperative years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality, morbidity and quality of life during the 2 postoperative years
Time Frame: during the 2 postoperative years
during the 2 postoperative years

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Laurent Hannoun, MD, PhD, Assistance Publique - Hôpitaux de Paris

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

September 1, 2009

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STIC ICO711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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