Colon Cancer Clinical Trial
Official title:
A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.
Laparoscopic complete mesocolic excision (CME) in treating colon cancer has been reported to
be feasible and safe and holds many advantages when compared with traditional open surgery,
such as reducing preoperative blood loss, alleviating postoperative pain and reducing
complications and length of hospital stay. Whether laparoscopic CME could achieve an
equivalent oncological outcome, especially for locally advanced malignancy, is still being
discussed.
The purpose of this study is to determine the short and long outcomes of open and
laparoscopic CME for locally advanced colon cancer patients. The primary endpoint is the
5-year disease-free survival rate. Secondary endpoints include completeness of mesocolon,
morbidity and mortality, local recurrence, overall survival, quality of life et al.
In this study, eligible patient will be randomly allocated to receive either open or
laparoscopic CME surgery. Randomization will be performed centrally and be stratified for
age, gender, T-stage, tumor location. Patients will be randomized in a 2:1 ratio, in favor
of the laparoscopic CME.
The extent of resection according to CME principle is identical for both arms. CME involves
the removal of the afflicted colon and its accessory lymphvascular supply at their origins
by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and
mesenteric fascia. Type of anastomosis, location of auxiliary incision and drainage of
surgical field are up to the discretion of the surgeon. In laparoscopic surgery, a
"medial-to-lateral" approach and a no-touch isolation are required .
Intraoperative pictures were taken at various stages, as were photographs of the
postoperative specimen, which will be assessed by a third-party expert to qualify the
surgery.
The baseline demographics and conditions as well as the perioperative and postoperative
outcomes will be recorded through a prior designed format.
Our study is expected to last seven years, of which two years for recruiting patients, five
years for follow-up. Patients are followed up every 3 months for 2 year, every 6 months for
3 years postoperatively.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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