Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer

NCT ID: NCT03426514

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-25
• Study Completion Date: 2025-03-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Three-port Laparoscopic Surgery

Patients with colorectal cancer undergo three-port laparoscopic surgery.

Group Type: EXPERIMENTAL

Three-port Laparoscopic Surgery

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Conventional Laparoscopic Surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Ren

Chief Physicion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tao Zhang, MD

Role: STUDY_CHAIR

Ruijin Hospital

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ren Zhao, MD

Role: CONTACT

rjzhaoren@139.com

+86-18917762018

Facility Contacts

Tao Zhang, MD

Role: primary

woodyhom@yahoo.com

+86-13918805942

References

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.

Reference Type: BACKGROUND

PMID: 25006515 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21234638 (View on PubMed)

Other Identifiers

RJ-TLSC-2018

Identifier Type: -

Identifier Source: org_study_id