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

Not Applicable

• Conditions: Overall Survival; Postoperative Complications

• 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

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