Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Procedure: Three-port Laparoscopic Surgery; Procedure: Conventional Laparoscopic Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03426514

RJ-TLSC-2018

Details and patient eligibility

About

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）.

Full description

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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Three-port Laparoscopic Surgery

Experimental group

Description:

Patients with colorectal cancer undergo three-port laparoscopic surgery.

Treatment:

Procedure: Three-port Laparoscopic Surgery

Conventional Laparoscopic Surgery

Experimental group

Description:

Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.

Treatment:

Procedure: Conventional Laparoscopic Surgery