Colonic Neoplasms Clinical Trial
Official title:
Laparoscopic Surgery for T4 Tumor of the Colon Cancer: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group Clinical Trial
The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.
The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon
cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an
alternative approach for T4 colon cancers with the advantage of faster recovery. However,
the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some
retrospective study and some prospective study in single institute with small sample of
patients. The aim of the present study is to compare the short-and long-term survival
outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well
as the mortality and the morbidity.
The number of patients needed to get a 80% power is 1960. The average number of
patients/surgical center is approximately 200 in each of 10 surgical centers.
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.
Systematically analyze and compare the disease free survival rate, the mortality, the
morbidity, and the proportion of completion of laparoscopic surgery of the two surgical
strategies (laparoscopy VS conventional open surgery).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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