Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

Study Overview
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Brief Summary
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To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.

Official Title
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Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

Conditions
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Overall Survival, Postoperative Complications, Stage, Colon Cancer, Metastasis

Intervention / Treatment
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* Procedure: CME
* Procedure: D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suitable for curative surgery 18-75years old Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complete Mesocolic Excision<br>the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck. | Procedure: CME<br>* the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed. Intervention: Procedure: Complete mesocolic excision (CME)<br>|
| Active Comparator: D3 lymph node dissection<br>the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group. | Procedure: D3<br>* the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels. Intervention: Procedure: D3 radical operation<br>|

What is the study measuring?
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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 complications and mortality |  | 30 days | 
| 3 years overall survival |  | 3 years | 
| The rate of local and distant recurrence |  | 3 years | 
| The accuracy of preoperative staging with CT |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CME, Right hemi Colon cancer, D3, laparoscopy