Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426514
• Other study ID #: RJ-TLSC-2018
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2018
• Est. completion date: March 2025

Study information

• Verified date: February 2020
• Source: Ruijin Hospital
• Contact: Ren Zhao, MD
• Phone: +86-18917762018
• Email: rjzhaoren[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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）.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: March 2025
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?-?

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early morbidity rate	morbidity rate 30 days after surgery	30 days after surgery
Secondary	Operative time	Operative time(minutes)	intraoperative
Secondary	Intraoperative blood loss	Estimated blood loss(milliliters,ml)	intraoperative
Secondary	Lymph node detection	Lymph nodes harvested(numbers)	14 days after surgery
Secondary	Proximal resection margin	Length of proximal margin (centimeters,cm)	14 days after surgery
Secondary	Distal resection margin	Length of distal margin (centimeters,cm)	14 days after surgery
Secondary	Length of stay	Duration of hospital stay(days after surgery)	1-14 days after surgery
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)	1-14 days after surgery
Secondary	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
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months after surgery
Secondary	5-year overall survival rate	5-year overall survival rate	60 months after surgery