Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
NCT ID: NCT02682589
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1080 participants
INTERVENTIONAL
2016-04-30
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Open surgery
A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.
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.
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.
Interventions
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Open surgery
A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Changhai Hospital
OTHER
Chinese PLA General Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Ruijin Hospital
OTHER
RenJi Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Fujian Medical University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Yueming Sun
Director of the Colorectal Surgery Department
Principal Investigators
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Fumin Zhang, Professor
Role: STUDY_DIRECTOR
Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
Locations
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Jiangsu province hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRSYM201602
Identifier Type: -
Identifier Source: org_study_id
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