Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer (NOTR)

January 19, 2020 updated by: Taiyuan Li

A Randomized Controlled Trial Comparing Clinical Outcomes of Natural Orifice Specimen Extraction Surgery Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100036
        • Recruiting
        • Chinese PLA General Hospital (301 Hospital) China
        • Contact:
          • Baoqing Jia, M.M., Ph.D
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Yanan Wang, M.M., Ph.D
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341 000
        • Recruiting
        • First Affiliated Hospital of Gannan Medical College
        • Contact:
      • Nanchang, Jiangxi, China, 360006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 360006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan hospital, Fudan university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 80 years;
  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:

  1. Not suitable for robot laparoscopic surgery;
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Natural Orifice Specimen Extraction Surgery
Natural orifice specimen extraction surgery will performed in patients assigned to this group.
Procedure: Natural Orifice Specimen Extraction Surgery
In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
Active Comparator: Traditional Robotic-assisted Surgery
Traditional robotic-assisted surgery will performed in patients assigned to this group.
Procedure: Traditional Robotic-assisted Surgery
In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of surgical complications
Time Frame: 30 days
Complication rate of surgery within 30 days after surgery.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The variation of C-reactive protein
Time Frame: Preoperative 3 days and postoperative 1, 3, and 7 days
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.
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-6(IL-6)
Time Frame: Preoperative 3 days and postoperative 1, 3, and 7 days
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.
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of interleukin-10(IL-10)
Time Frame: Preoperative 3 days and postoperative 1, 3, and 7 days
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.
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of cortisol
Time Frame: Preoperative 3 days and postoperative 1, 3, and 7 days
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.
Preoperative 3 days and postoperative 1, 3, and 7 days
The variation of lymphocyte subsets count of CD3, CD4 and CD8
Time Frame: Preoperative 3 days and postoperative 1, 3, and 7 days
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.
Preoperative 3 days and postoperative 1, 3, and 7 days
The positive rate of malignant cells in ascitic fluid specimen
Time Frame: 1 day
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
1 day
The positive rate of bacterial culture in ascitic fluid specimen
Time Frame: 1 day
Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
1 day
Postoperative pain score
Time Frame: 1 day
Postoperative pain score will be assessed by visual analog score.
1 day
Time to first flatus
Time Frame: 30 days
Time to first flatus is used to assess the postoperative recovery course
30 days
Time to leave bed postoperatively
Time Frame: 30 days
Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course.
30 days
Time to first liquid diet postoperatively
Time Frame: 30 days
Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course.
30 days
Postoperative hospital stay
Time Frame: 30 days
Postoperative hospital stay is used to assess the postoperative recovery course.
30 days
Operation time
Time Frame: 1 day
Time from start of incision to finish of abdominal closure.
1 day
Estimated blood loss
Time Frame: 1 day
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
1 day
Number of retrieved lymph nodes
Time Frame: 1 day
Number of retrieved lymph nodes will be determined according to the pathological report.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taiyuan Li

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Taiyuan Li, M.D., Ph.D, Department of General Surgery, The First Affiliated Hospital of Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ndyfy660618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings