Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer (OLCMECC)
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|ClinicalTrials.gov Identifier: NCT02682589|
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : July 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Procedure: Open surgery Procedure: Laparoscopic surgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1080 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Active Comparator: Open surgery
Patients undergo open CME. A standard midline incision carefully protected is made through the abdominal wall and the abdominal cavity is explored. A colectomy with CME is performed with the removal of the afflicted colon and its accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia.
Procedure: Open surgery
A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.
Experimental: Laparoscopic surgery
Patients undergo laparoscopic CME. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with carbon dioxide to allow access and visualization. The abdominal cavity is explored. A colectomy with CME is performed using laparoscopic-assisted techniques. A 6-8cm midline auxiliary incision is made for specimen extraction and anastomosis.
Procedure: Laparoscopic surgery
3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study.
- disease-free survival [ Time Frame: 5 years ]
- overall survival [ Time Frame: 5 years ]
- recurrence-free survival [ Time Frame: 5 years ]
- local recurrence rate [ Time Frame: 5 years ]
- length of postoperative hospital stay [ Time Frame: 30 days ]Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.
- early complication rate [ Time Frame: 30 days ]Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day 30. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
- operative time [ Time Frame: 1 day ]
- completeness of the mesocolon of the specimen [ Time Frame: 1 day ]A central review by pathologists to define the completeness of the mesocolon to be good, moderate or poor will be performed on the specimen photographs.
- number of lymph nodes retrieved [ Time Frame: 1 day ]
- postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire [ Time Frame: 5 years ]Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQ-C30 questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682589
|Contact: Yueming Sun, PhDfirstname.lastname@example.org|
|Jiangsu province hospital||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Yueming Sun 68136026 email@example.com|
|Study Director:||Fumin Zhang, Professor||Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital|