Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

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

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）.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Three-port Laparoscopic Surgery; Procedure: Conventional Laparoscopic Surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 282
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ren Zhao, MD; Phone Number: +86-18917762018; Email: rjzhaoren@139.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: Tao Zhang, MD; Phone Number: +86-13918805942; Email: woodyhom@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three-port Laparoscopic Surgery; Patients with colorectal cancer undergo three-port laparoscopic surgery.	Procedure: Three-port Laparoscopic Surgery; 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.
Experimental: Conventional Laparoscopic Surgery; Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.	Procedure: Conventional Laparoscopic Surgery; 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.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Tao Zhang, MD, Ruijin Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Colorectal cancer; Three-port
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RJ-TLSC-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No