Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer

Phase 3

• Conditions: Colon Cancer
• Interventions: Procedure: Open surgery; Procedure: Laparoscopic surgery

• Registration Number: NCT02682589
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Study Start: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-03
• Last Update Posted: 2016-07-06
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1080

Inclusion Criteria

• Patients suitable for curative surgery over 18 years old;
• American Society of Anesthesiologists(ASA) grade I-III;
• Pathological diagnosis of adenocarcinoma;
• Tumor located between the cecum and sigmoid colon;
• Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
• Informed consent;
• No preoperative chemoradiotherapy;
• No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria

• Pregnant patient;

• History of psychiatric disease;

• Use of systemic steroids;

• Conversion to laparotomy;

• Simultaneous or simultaneous multiple primary colorectal cancer;

• Preoperative imaging examination results show:

  1. Tumor involves the surrounding organs and combined organ resection need to be done;
  2. distant metastasis;
  3. unable to perform R0 resection;

• Postoperative pathology of T1-T2 N0;

• History of any other malignant tumor in recent 5 years;

• Patients need emergency operation: mechanic ileus, perforation.

• Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open surgery	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.
Laparoscopic surgery	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.

Primary Outcome Measures

Name	Time	Method
disease-free survival	5 years

Secondary Outcome Measures

Name	Time	Method
number of lymph nodes retrieved	1 day
operative time	1 day
recurrence-free survival	5 years
local recurrence rate	5 years
length of postoperative hospital stay	30 days	Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire	5 years	Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQ-C30 questionnaire
overall survival	5 years
early complication rate	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.
completeness of the mesocolon of the specimen	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.

Trial Locations

Locations (1)

Jiangsu province hospital; 🇨🇳 Nanjing, Jiangsu, China