Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
transrectal specimen extraction
Conventional laparoscopic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, laparoscopic surgery, natural orifice specimen extraction, Inflammatory response
Eligibility Criteria
Inclusion Criteria:
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
- Pathological rectosigmoid adenocarcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
- Tumor size of 6 cm or less;
- Eastern Cooperative Oncology Group (ECOG) score is 0-1
- American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
- Informed consent
Exclusion Criteria:
- Body mass index (BMI) >30 kg/m2
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
transrectal specimen extraction
Conventional laparoscopic surgery
Arm Description
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Outcomes
Primary Outcome Measures
Early morbidity rate
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
Secondary Outcome Measures
Duration of the intervention
Duration of surgery.
Peritoneal bacterial contamination
Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.
Pain score
Recording of the needed analgesia guided by pain score
3-year disease free survival rate
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
5-year overall survival rate
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Plasma levels of several cytokines after colorectal cancer surgery
We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.
Full Information
NCT ID
NCT02635503
First Posted
November 30, 2015
Last Updated
September 1, 2016
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02635503
Brief Title
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
Official Title
A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
Detailed Description
Further study details as provided by Chinese Academy of Medical Sciences.
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, natural orifice specimen extraction, Inflammatory response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transrectal specimen extraction
Arm Type
Experimental
Arm Description
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
Arm Title
Conventional laparoscopic surgery
Arm Type
Active Comparator
Arm Description
Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
Intervention Type
Procedure
Intervention Name(s)
transrectal specimen extraction
Other Intervention Name(s)
NOSE
Intervention Description
After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic surgery
Other Intervention Name(s)
CLS
Intervention Description
High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.
Primary Outcome Measure Information:
Title
Early morbidity rate
Description
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Duration of the intervention
Description
Duration of surgery.
Time Frame
1 day
Title
Peritoneal bacterial contamination
Description
Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.
Time Frame
1 day
Title
Pain score
Description
Recording of the needed analgesia guided by pain score
Time Frame
14 days
Title
3-year disease free survival rate
Description
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Time Frame
3 years
Title
5-year overall survival rate
Description
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Time Frame
5 years
Title
Plasma levels of several cytokines after colorectal cancer surgery
Description
We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years < age < 80 years
Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
Pathological rectosigmoid adenocarcinoma
Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
Tumor size of 6 cm or less;
Eastern Cooperative Oncology Group (ECOG) score is 0-1
American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
Informed consent
Exclusion Criteria:
Body mass index (BMI) >30 kg/m2
Pregnant woman or lactating woman
Severe mental disease
Previous abdominal surgery
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
Zhixiang Zhou, M.D.
Phone
+86-139-1123-2981
Email
Dr_zhouzx@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianwei Liang, M.D.
Phone
+86-130-7119-7461
Email
liangjw1976@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiang Zhou, M.D.
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Liang, M.D.
Phone
+86-130-7119-7461
Email
liangjw1976@126.com
First Name & Middle Initial & Last Name & Degree
Zhixiang Zhou, M.D.
Phone
+86-139-1123-2981
Email
Dr_zhouzx@163.com
First Name & Middle Initial & Last Name & Degree
Zhixiang Zhou, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
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