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

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial: Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy

Conditions
-----------------
Overall Survival, Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: DML group
* Procedure: MLA group


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Tumor involves the surrounding organs and combined organ resection need to be done; Distant metastasis; 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DML group<br>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. | Procedure: DML group<br>* The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.<br>|
| Active Comparator: MLA group<br>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. | Procedure: MLA group<br>* The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of postoperative complication |  | 30 days | 
| 3 years overall survival |  | 3 years | 
| The rate of local and distant recurrence |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical approach, Laparoscopic right hemicolectomy