Laparoscopic Complete Mesocolic Excision on Colon Cancer

NCT01628250 | Completed Results DMC

• 1 other identifier: SH-MIS
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.

Conditions

Operation Finding; Complications; Pathology; Quality of Life; Neoplasms Recurrence

Outcome Measures

Primary Outcomes (1)

• Histopathological Outcomes Obtained Through the Surgeries

  number of lymph nodes retrieved

  14 days after the surgery

Secondary Outcomes (1)

• Survival Rate

  3 years after the surgery

Study Arms (2)

laparoscopic complete mesocolic excision

ACTIVE COMPARATOR

Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision

Procedure: laparoscopic complete mesocolic excision

D3 laparoscopic colectomy

ACTIVE COMPARATOR

Randomized group of patients receiving laparoscopic colectomy with D3-resection

Procedure: D3-laparoscopic colectomy

Interventions

laparoscopic complete mesocolic excision PROCEDURE

laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.

Also known as: laparoscopic CME, Complete Medial Approach (CMA), Hybrid Medial Approach (HMA)

laparoscopic complete mesocolic excision

D3-laparoscopic colectomy PROCEDURE

D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.

Also known as: D3 laparoscopic colectomy

D3 laparoscopic colectomy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically confirmed colon cancer
• Signed consent

You may not qualify if:

• History of malignancy
• Intestinal obstruction or perforation
• Evidence of metastasis by preoperative examinations
• Deformity of spine
• Emergency case
• BMI \> 29

Sponsors & Collaborators

• Bo Feng: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Results Point of Contact

• Title: Dr. Bo Feng
• Organization: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

fengbo2022@163.com

021-64458887

Study Officials

• Bo Feng, MD/PhD

  Shanghai Minimally Invasive Surgery Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research chair of MIS

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 26, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 15, 2022
• Results First Posted: June 29, 2016

Record last verified: 2022-10

Locations

CN (1)