Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Study Overview
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Brief Summary
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This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.

Detailed Description
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At present，surgical treatments is the main means to cure colorectal cancer（CRC）.The use of four or more ports has been routine in most laparoscopic colorectal resections. However，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer（TLSC） have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.

Official Title
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Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Three-port Laparoscopic Surgery
* Procedure: Conventional Laparoscopic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) <30 kg/m2 Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection) Pathological colorectal carcinoma Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history ECOG score is 0-1 ASA score is Ⅰ-Ⅲ Informed consent Exclusion Criteria: Previous gastrointestinal surgery History of inflammatory bowel disease History of familial adenomatous polyposis（FAP） Pregnant woman or lactating woman Severe mental disease Intolerance of surgery for severe comorbidities Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer Requirement of simultaneous surgery for other disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-port Laparoscopic Surgery<br>Patients with colorectal cancer undergo three-port laparoscopic surgery. | Procedure: Three-port Laparoscopic Surgery<br>* Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.<br>|
| Experimental: Conventional Laparoscopic Surgery<br>Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）. | Procedure: Conventional Laparoscopic Surgery<br>* Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early morbidity rate | morbidity rate 30 days after surgery | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time（minutes） | intraoperative | 
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | intraoperative | 
| Lymph node detection | Lymph nodes harvested（numbers） | 14 days after surgery | 
| Proximal resection margin | Length of proximal margin （centimeters，cm） | 14 days after surgery | 
| Distal resection margin | Length of distal margin （centimeters，cm） | 14 days after surgery | 
| Length of stay | Duration of hospital stay（days after surgery） | 1-14 days after surgery | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） | 1-14 days after surgery | 
| Pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge | 1-3 days after surgery | 
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months after surgery | 
| 5-year overall survival rate | 5-year overall survival rate | 60 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Laparoscopic surgery, Three-port