Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
NOTR
A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
1 other identifier
interventional
550
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJanuary 22, 2020
January 1, 2020
11 months
January 14, 2020
January 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of surgical complications
Complication rate of surgery within 30 days after surgery.
30 days
Secondary Outcomes (15)
The variation of C-reactive protein
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-6(IL-6)
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-10(IL-10)
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of cortisol
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of lymphocyte subsets count of CD3, CD4 and CD8
Preoperative 3 days and postoperative 1, 3, and 7 days
- +10 more secondary outcomes
Study Arms (2)
Natural Orifice Specimen Extraction Surgery
EXPERIMENTALNatural orifice specimen extraction surgery will performed in patients assigned to this group.
Traditional Robotic-assisted Surgery
ACTIVE COMPARATORTraditional robotic-assisted surgery will performed in patients assigned to this group.
Interventions
In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taiyuan Lilead
Study Sites (7)
Chinese PLA General Hospital (301 Hospital) China
Beijing, Beijing Municipality, 100036, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, 341 000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 360006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 360006, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
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.
PMID: 33549133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taiyuan Li, M.D., Ph.D
Department of General Surgery, The First Affiliated Hospital of Nanchang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof., Chief physician, Head of The Fifth Department of General Surgery
Study Record Dates
First Submitted
January 14, 2020
First Posted
January 18, 2020
Study Start
February 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
January 22, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share