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

Shanghai Minimally Invasive Surgery Center

Status: Unknown

Conditions: Postoperative Complications; Overall Survival

Treatments: Procedure: MLA group; Procedure: DML group

Study type: Interventional

Funder types: Other

Identifiers

NCT03364478

ShanghaiMISC-RHC

Details and patient eligibility

About

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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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326 participants in 2 patient groups

DML group

Experimental group

Description:

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.

Treatment:

Procedure: DML group

MLA group

Active Comparator group

Description:

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.

Treatment:

Procedure: MLA group