Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
NCT ID: NCT04230772
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
550 participants
INTERVENTIONAL
2021-02-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective Single-center Randomized Controlled Trial of Robotic Surgery with Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer
NCT06906952
Robotic Natural Orifice Specimen Extraction Surgery Compared to Robotic Assisted Surgery for Median Rectal Cancer
NCT06454201
Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study
NCT06350370
Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer
NCT06405308
Clinical Outcomes and Prognostic Factors of Robotic Assisted Rectal Cancer Resection Alone vs. Robotic Rectal Cancer Resection With Natural Orifice Specimen Extraction
NCT04265417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Natural Orifice Specimen Extraction Surgery
Natural orifice specimen extraction surgery will performed in patients assigned to this group.
Natural Orifice Specimen Extraction Surgery
In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
Traditional Robotic-assisted Surgery
Traditional robotic-assisted surgery will performed in patients assigned to this group.
Traditional Robotic-assisted Surgery
In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Natural Orifice Specimen Extraction Surgery
In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
Traditional Robotic-assisted Surgery
In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
3. Histological or cytological confirmation of colorectal adenocarcinoma;
4. High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
5. 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;
6. Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
7. Cardiopulmonary liver and kidney function can withstand surgery;
8. Written informed consent for participation in the trial.
Exclusion Criteria
2. The tumor is too large to be pulled out through the anus or vagina;
3. Simultaneous multiple primary cancer;
4. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer
5. Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taiyuan Li
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Taiyuan Li
Prof., Chief physician, Head of The Fifth Department of General Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Taiyuan Li, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of General Surgery, The First Affiliated Hospital of Nanchang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chinese PLA General Hospital (301 Hospital) China
Beijing, Beijing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Baoqing Jia, M.M., Ph.D
Role: primary
Yanan Wang, M.M., Ph.D
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ndyfy660618
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.