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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04230772
Other study ID # ndyfy660618
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2022

Study information

Verified date January 2020
Source The First Affiliated Hospital of Nanchang University
Contact Taiyuan Li, M.D., Ph.D
Phone +86-13970031518
Email jylitaiyuan@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 550
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
China Chinese PLA General Hospital (301 Hospital) China Beijing Beijing
China The Second Xiangya Hospital of Central South University Changsha Hunan
China First Affiliated Hospital of Gannan Medical College Ganzhou Jiangxi
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong
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

Sponsors (1)

Lead Sponsor Collaborator
Taiyuan Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of surgical complications Complication rate of surgery within 30 days after surgery. 30 days
Secondary 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. Preoperative 3 days and postoperative 1, 3, and 7 days
Secondary 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. Preoperative 3 days and postoperative 1, 3, and 7 days
Secondary 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. Preoperative 3 days and postoperative 1, 3, and 7 days
Secondary 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. Preoperative 3 days and postoperative 1, 3, and 7 days
Secondary 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. Preoperative 3 days and postoperative 1, 3, and 7 days
Secondary The positive rate of malignant cells in ascitic fluid specimen Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory. 1 day
Secondary The positive rate of bacterial culture in ascitic fluid specimen Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory. 1 day
Secondary Postoperative pain score Postoperative pain score will be assessed by visual analog score. 1 day
Secondary Time to first flatus Time to first flatus is used to assess the postoperative recovery course 30 days
Secondary Time to leave bed postoperatively Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course. 30 days
Secondary Time to first liquid diet postoperatively Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course. 30 days
Secondary Postoperative hospital stay Postoperative hospital stay is used to assess the postoperative recovery course. 30 days
Secondary Operation time Time from start of incision to finish of abdominal closure. 1 day
Secondary Estimated blood loss Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. 1 day
Secondary Number of retrieved lymph nodes Number of retrieved lymph nodes will be determined according to the pathological report. 1 day
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