Clinical trial NCT03426514: Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Official title: Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Laparoscopic surgery
Three-port
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Early morbidity rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Lymph node detection
timeFrame: 14 days after surgery
measure: Proximal resection margin
timeFrame: 14 days after surgery
measure: Distal resection margin
timeFrame: 14 days after surgery
measure: Length of stay
timeFrame: 1-14 days after surgery
measure: Postoperative recovery course
timeFrame: 1-14 days after surgery
measure: Pain score
timeFrame: 1-3 days after surgery
measure: 3-year disease free survival rate
timeFrame: 36 months after surgery
measure: 5-year overall survival rate
timeFrame: 60 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Tao Zhang, MD
role: STUDY_CHAIR
References:
citation: Tawfik Amin A, Elsaba TM, Amira G. Three ports laparoscopic resection for colorectal cancer: a step on refining of reduced port surgery. ISRN Surg. 2014 Mar 12;2014:781549. doi: 10.1155/2014/781549. eCollection 2014.
citation: Seow-En I, Tan KY, Mohd Daud MA, Seow-Choen F. Traditional laparoscopic colorectal resections can be performed effectively using a three-port technique. Tech Coloproctol. 2011 Mar;15(1):91-3. doi: 10.1007/s10151-010-0660-6. Epub 2011 Jan 14. No abstract available.