Back to resultsClinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer (NOTR)
Primary Purpose
Colorectal Neoplasms, Neoplasms Malignant, Complication of Surgical Procedure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Natural Orifice Specimen Extraction Surgery
Traditional Robotic-assisted Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 80 years;
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- Histological or cytological confirmation of colorectal adenocarcinoma;
- High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
- T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;
- Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
- Cardiopulmonary liver and kidney function can withstand surgery;
- Written informed consent for participation in the trial.
Exclusion Criteria:
- Not suitable for robot laparoscopic surgery;
- The tumor is too large to be pulled out through the anus or vagina;
- Simultaneous multiple primary cancer;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
- Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
Sites / Locations
- Chinese PLA General Hospital (301 Hospital) ChinaRecruiting
- Nanfang Hospital, Southern Medical UniversityRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- First Affiliated Hospital of Gannan Medical CollegeRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- The Second Affiliated Hospital of Nanchang UniversityRecruiting
- Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Natural Orifice Specimen Extraction Surgery
Traditional Robotic-assisted Surgery
Arm Description
Natural orifice specimen extraction surgery will performed in patients assigned to this group.
Traditional robotic-assisted surgery will performed in patients assigned to this group.
Outcomes
Primary Outcome Measures
Incidence of surgical complications
Complication rate of surgery within 30 days after surgery.
Secondary Outcome Measures
The variation of C-reactive protein
The values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
The variation of interleukin-6(IL-6)
The values of interleukin-6(IL-6) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
The variation of interleukin-10(IL-10)
The values of interleukin-10(IL-10) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
The variation of cortisol
The values of cortisol from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
The variation of lymphocyte subsets count of CD3, CD4 and CD8
The values of lymphocyte subsets count of CD3, CD4 and CD8 from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
The positive rate of malignant cells in ascitic fluid specimen
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
The positive rate of bacterial culture in ascitic fluid specimen
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
Postoperative pain score
Postoperative pain score will be assessed by visual analog score.
Time to first flatus
Time to first flatus is used to assess the postoperative recovery course
Time to leave bed postoperatively
Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course.
Time to first liquid diet postoperatively
Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course.
Postoperative hospital stay
Postoperative hospital stay is used to assess the postoperative recovery course.
Operation time
Time from start of incision to finish of abdominal closure.
Estimated blood loss
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Number of retrieved lymph nodes
Number of retrieved lymph nodes will be determined according to the pathological report.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04230772
Brief Title
Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
Acronym
NOTR
Official Title
A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taiyuan Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
Detailed Description
Based on investigators' experience, compared to robotic-assisted colorectal cancer radical resection, robotic colorectal cancer radical resection with natural orifice extraction has more advantages in postoperative stress response, postoperative pain, postoperative recovery and postoperative abdominal aesthetics. However, in terms of tumor radicality, there may be no obvious differences. There are no randomized controlled trails to discuss these questions.This research is based on the above conditions. Investigators use prospective randomized controlled trial to analyze the surgical data, postoperative complications, postoperative recovery of the robotic colorectal cancer radical resection with natural orifice extraction and conventional robotic-assisted colorectal cancer radical resection in order to summarize clinical experience and explore the advantages and disadvantages of robotic colorectal cancer radical resection with natural orifice specimen extraction and to provide a new direction for the surgical treatment of colorectal cancer, which is beneficial to the promotion of NOSES(Natural Orifice Specimen Extraction Surgery ) technology and treatment of colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Neoplasms Malignant, Complication of Surgical Procedure, Robotic Surgical Procedures, Natural Orifice Specimen Extraction Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Natural Orifice Specimen Extraction Surgery
Arm Type
Experimental
Arm Description
Natural orifice specimen extraction surgery will performed in patients assigned to this group.
Arm Title
Traditional Robotic-assisted Surgery
Arm Type
Active Comparator
Arm Description
Traditional robotic-assisted surgery will performed in patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Natural Orifice Specimen Extraction Surgery
Intervention Description
In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
Intervention Type
Procedure
Intervention Name(s)
Traditional Robotic-assisted Surgery
Intervention Description
In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.
Primary Outcome Measure Information:
Title
Incidence of surgical complications
Description
Complication rate of surgery within 30 days after surgery.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
The variation of C-reactive protein
Description
The values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 7 days
Title
The variation of interleukin-6(IL-6)
Description
The values of interleukin-6(IL-6) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 7 days
Title
The variation of interleukin-10(IL-10)
Description
The values of interleukin-10(IL-10) from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 7 days
Title
The variation of cortisol
Description
The values of cortisol from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 7 days
Title
The variation of lymphocyte subsets count of CD3, CD4 and CD8
Description
The values of lymphocyte subsets count of CD3, CD4 and CD8 from peripheral blood before operation and on postoperative day 1, 3, 7 are recorded to access the surgical response stress and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 7 days
Title
The positive rate of malignant cells in ascitic fluid specimen
Description
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
Time Frame
1 day
Title
The positive rate of bacterial culture in ascitic fluid specimen
Description
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
Time Frame
1 day
Title
Postoperative pain score
Description
Postoperative pain score will be assessed by visual analog score.
Time Frame
1 day
Title
Time to first flatus
Description
Time to first flatus is used to assess the postoperative recovery course
Time Frame
30 days
Title
Time to leave bed postoperatively
Description
Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first liquid diet postoperatively
Description
Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Postoperative hospital stay
Description
Postoperative hospital stay is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Operation time
Description
Time from start of incision to finish of abdominal closure.
Time Frame
1 day
Title
Estimated blood loss
Description
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Time Frame
1 day
Title
Number of retrieved lymph nodes
Description
Number of retrieved lymph nodes will be determined according to the pathological report.
Time Frame
1 day
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:
Age ≥ 18 and ≤ 80 years;
Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
Histological or cytological confirmation of colorectal adenocarcinoma;
High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of <5 cm;
Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
Cardiopulmonary liver and kidney function can withstand surgery;
Written informed consent for participation in the trial.
Exclusion Criteria:
Not suitable for robot laparoscopic surgery;
The tumor is too large to be pulled out through the anus or vagina;
Simultaneous multiple primary cancer;
Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taiyuan Li, M.D., Ph.D
Phone
+86-13970031518
Email
jylitaiyuan@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongning Liu, M.D., Ph.D
Phone
+86-13576982921
Email
liudongning1982@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taiyuan Li, M.D., Ph.D
Organizational Affiliation
Department of General Surgery, The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital (301 Hospital) China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoqing Jia, M.M., Ph.D
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanan Wang, M.M., Ph.D
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongliang Yao, M.M., Ph.D
Email
yaohl0326@163.com
Facility Name
First Affiliated Hospital of Gannan Medical College
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341 000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangfu Zeng, M.M., Ph.d
Email
xiaoxiaoliu1982@163.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
360006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taiyuan Li, M.M., Ph.D
Phone
13970031518
Email
jylitaiyuan@sina.com
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
360006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengxun Mao, MM., Ph.D
Email
maoshengxun@163.com
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Wei, M.M.,Ph.D
Email
13818661815@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33549133
Citation
Luo R, Zheng F, Zhang H, Zhu W, He P, Liu D. Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial. Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z.
Results Reference
derived
Learn more about this trial
Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
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