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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

550

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Taiyuan Li

Investigators

  • 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)

February 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

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