Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Three-port Laparoscopic Surgery
Conventional Laparoscopic Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Laparoscopic surgery, Three-port
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
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Three-port Laparoscopic Surgery
Conventional Laparoscopic Surgery
Arm Description
Patients with colorectal cancer undergo three-port laparoscopic surgery.
Patients with colorectal cancer undergo conventional laparoscopic surgery(4 or more ports).
Outcomes
Primary Outcome Measures
Early morbidity rate
morbidity rate 30 days after surgery
Secondary Outcome Measures
Operative time
Operative time(minutes)
Intraoperative blood loss
Estimated blood loss(milliliters,ml)
Lymph node detection
Lymph nodes harvested(numbers)
Proximal resection margin
Length of proximal margin (centimeters,cm)
Distal resection margin
Length of distal margin (centimeters,cm)
Length of stay
Duration of hospital stay(days after surgery)
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet (hours 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
3-year disease free survival rate
3-year disease free survival rate
5-year overall survival rate
5-year overall survival rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03426514
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Laparoscopic surgery, Three-port
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Three-port Laparoscopic Surgery
Arm Type
Experimental
Arm Description
Patients with colorectal cancer undergo three-port laparoscopic surgery.
Arm Title
Conventional Laparoscopic Surgery
Arm Type
Experimental
Arm Description
Patients with colorectal cancer undergo conventional laparoscopic surgery(4 or more ports).
Intervention Type
Procedure
Intervention Name(s)
Three-port Laparoscopic Surgery
Intervention Description
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
Intervention Name(s)
Conventional Laparoscopic Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early morbidity rate
Description
morbidity rate 30 days after surgery
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Operative time
Description
Operative time(minutes)
Time Frame
intraoperative
Title
Intraoperative blood loss
Description
Estimated blood loss(milliliters,ml)
Time Frame
intraoperative
Title
Lymph node detection
Description
Lymph nodes harvested(numbers)
Time Frame
14 days after surgery
Title
Proximal resection margin
Description
Length of proximal margin (centimeters,cm)
Time Frame
14 days after surgery
Title
Distal resection margin
Description
Length of distal margin (centimeters,cm)
Time Frame
14 days after surgery
Title
Length of stay
Description
Duration of hospital stay(days after surgery)
Time Frame
1-14 days after surgery
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery)
Time Frame
1-14 days after surgery
Title
Pain score
Description
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
Time Frame
1-3 days after surgery
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months after surgery
Title
5-year overall survival rate
Description
5-year overall survival rate
Time Frame
60 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ren Zhao, MD
Phone
+86-18917762018
Email
rjzhaoren@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Zhang, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhang, MD
Phone
+86-13918805942
Email
woodyhom@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25006515
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.
Results Reference
background
PubMed Identifier
21234638
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.
Results Reference
background
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Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer
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