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

Not Applicable

• Conditions: Neoplasms Malignant; Complication of Surgical Procedure; Natural Orifice Specimen Extraction Surgery; Colorectal Neoplasms; Robotic Surgical Procedures
• Interventions: Procedure: Natural Orifice Specimen Extraction Surgery; Procedure: Traditional Robotic-assisted Surgery

• Registration Number: NCT04230772
• Lead Sponsor: Taiyuan Li

Brief 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.

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 Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22
• Study Start: 2021-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural Orifice Specimen Extraction Surgery	Natural Orifice Specimen Extraction Surgery	Natural orifice specimen extraction surgery will performed in patients assigned to this group.
Traditional Robotic-assisted Surgery	Traditional Robotic-assisted Surgery	Traditional robotic-assisted surgery will performed in patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
Incidence of surgical complications	30 days	Complication rate of surgery within 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
The variation of C-reactive protein	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.
The variation of interleukin-6(IL-6)	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.
The positive rate of malignant cells in ascitic fluid specimen	1 day	Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
The positive rate of bacterial culture in ascitic fluid specimen	1 day	Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory.
Postoperative pain score	1 day	Postoperative pain score will be assessed by visual analog score.
Time to first flatus	30 days	Time to first flatus is used to assess the postoperative recovery course
Time to leave bed postoperatively	30 days	Time to first leave bed postoperatively in hours is used to assess the postoperative recovery course.
The variation of interleukin-10(IL-10)	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.
The variation of cortisol	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.
The variation of lymphocyte subsets count of CD3, CD4 and CD8	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.
Time to first liquid diet postoperatively	30 days	Time to first liquid diet postoperatively in days is used to assess the postoperative recovery course.
Postoperative hospital stay	30 days	Postoperative hospital stay is used to assess the postoperative recovery course.
Operation time	1 day	Time from start of incision to finish of abdominal closure.
Estimated blood loss	1 day	Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Number of retrieved lymph nodes	1 day	Number of retrieved lymph nodes will be determined according to the pathological report.

Trial Locations

Locations (7)

Chinese PLA General Hospital (301 Hospital) China; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

First Affiliated Hospital of Gannan Medical College; 🇨🇳 Ganzhou, Jiangxi, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China