Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer

NCT02682589 | Unknown Phase 3 DMC

• 1 other identifier: CRSYM201602
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

Complete Mesocolic Excision; locally advanced Colon Cancer; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  5 years

Secondary Outcomes (9)

• overall survival

  5 years

• recurrence-free survival

  5 years

• local recurrence rate

  5 years

• length of postoperative hospital stay

  30 days

• early complication rate

  30 days

Study Arms (2)

Open surgery

ACTIVE COMPARATOR

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

Laparoscopic surgery

EXPERIMENTAL

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

Interventions

Open surgery PROCEDURE

A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.

Open surgery

Laparoscopic surgery PROCEDURE

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.

Laparoscopic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Tumor involves the surrounding organs and combined organ resection need to be done;
• distant metastasis;
• 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).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• West China Hospital: collaborator
• Changhai Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Ruijin Hospital: collaborator
• RenJi Hospital: collaborator
• Shanghai Changzheng Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Fujian Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Jiangsu province hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Conversion to Open Surgery; Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Fumin Zhang, Professor

  Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

  STUDY DIRECTOR

Central Study Contacts

Yueming Sun, PhD

CONTACT

02568136026; jssym@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Colorectal Surgery Department

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 15, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 6, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)