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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01772407
First received: January 17, 2013
Last updated: June 13, 2014
Last verified: January 2013
  Purpose

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


Condition
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Cost during the 2 postoperative years [ Time Frame: during the 2 postoperative years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality, morbidity and quality of life during the 2 postoperative years [ Time Frame: during the 2 postoperative years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
laparoscopic surgery in right colon cancer operations
2
open surgery in right colon cancer operations

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Right colon cancer < T4 without metastasis needing colectomy

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant patient
  • T4 cancer
  • Metastasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772407

Contacts
Contact: Jean_Jacques Duron, MD, PhD 33142175622 jean-jacques.duron@psl.aphp.fr

Locations
France
Pitié-Salpetrière Hospital Recruiting
Paris, France, 75013
Sub-Investigator: Jean-Jacques Duron, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent Hannoun, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01772407     History of Changes
Other Study ID Numbers: STIC ICO711
Study First Received: January 17, 2013
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colon Cancer Surgery
Laparoscopy
Open surgery
Costs
Mortality
Morbidity
Quality of life

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014