Laparoscopic Complete Mesocolic Excision on Colon Cancer

NCT ID: NCT01628250

Last Updated: 2022-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Operation Finding Complications Pathology Quality of Life Neoplasms Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic complete mesocolic excision

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

Group Type ACTIVE_COMPARATOR

laparoscopic complete mesocolic excision

Intervention Type 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.

D3 laparoscopic colectomy

Randomized group of patients receiving laparoscopic colectomy with D3-resection

Group Type ACTIVE_COMPARATOR

D3-laparoscopic colectomy

Intervention Type PROCEDURE

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

Interventions

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laparoscopic complete mesocolic excision

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.

Intervention Type PROCEDURE

D3-laparoscopic colectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic CME Complete Medial Approach (CMA) Hybrid Medial Approach (HMA) D3 laparoscopic colectomy

Eligibility Criteria

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Inclusion Criteria

* Patients with pathologically confirmed colon cancer
* Signed consent

Exclusion Criteria

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

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bo Feng

OTHER

Sponsor Role lead

Responsible Party

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Bo Feng

Research chair of MIS

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bo Feng, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Minimally Invasive Surgery Center

Locations

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Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SH-MIS

Identifier Type: -

Identifier Source: org_study_id

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