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

Colorectal Neoplasms Clinical Trial

— NOTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230772
• Other study ID #: ndyfy660618
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Complication of Surgical Procedure
• Natural Orifice Specimen Extraction Surgery
• Neoplasms
• Neoplasms Malignant
• Robotic Surgical Procedures

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