Colon Cancer Clinical Trial
Official title:
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
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.
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