Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy

Not Applicable

• Conditions: Overall Survival; Postoperative Complications
• Interventions: Procedure: DML group; Procedure: MLA group

• Registration Number: NCT03364478
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

Brief Summary

To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-06
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-14
• Study Start: 2018-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

• Aged more then 18 years old;
• Diagnosed as right hemi colonic cancer with colonoscopic biopsy;
• Without metastasis;
• No Invasion of surrounding tissues;
• Limited operation;
• Underwent laparoscopic radical right hemicolectomy (L-right hemicolectomy);
• BMI 18~30kg/m2;
• Without multiple primary tumors;
• Sign on the Medical informed Consent.

Exclusion Criteria

• 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;

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

• Patients need emergency operation;

• Not suitable for laparoscopic surgery;

• Women during Pregnancy or breast feeding period;

• Informed consent refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DML group	DML group	The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach. In DML group, the dissecting based on CME is performed with dorsal approach and medial approach hybridized.
MLA group	MLA group	The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach. In MLA group,the dissecting based on CME is performed with meidial-to-lateral approach.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
The rate of postoperative complication	30 days
3 years overall survival	3 years
The rate of local and distant recurrence	3 years

Trial Locations

Locations (1)

Shanghai Ruijin Hospttal; 🇨🇳 Shanghai, Sahgnhai, China