Trial Information

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

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.