Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery? (CHIRCOL)
|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|
- Cost during the 2 postoperative years [ Time Frame: during the 2 postoperative years ] [ Designated as safety issue: No ]
- Mortality, morbidity and quality of life during the 2 postoperative years [ Time Frame: during the 2 postoperative years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
laparoscopic surgery in right colon cancer operations
open surgery in right colon cancer operations
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772407
|Contact: Jean_Jacques Duron, MD, PhDfirstname.lastname@example.org|
|Paris, France, 75013|
|Sub-Investigator: Jean-Jacques Duron, MD, PhD|
|Sub-Investigator: Mehdi Karoui, MD, PhD|
|Sub-Investigator: Gilles Manceau, MD, PhD|
|Principal Investigator:||Laurent Hannoun, MD, PhD||Assistance Publique - Hôpitaux de Paris|