Clinical trial NCT04230772: Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Neoplasms Malignant
Complication of Surgical Procedure
Robotic Surgical Procedures
Natural Orifice Specimen Extraction Surgery
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of surgical complications
timeFrame: 30 days
Secondary outcomes:
measure: The variation of C-reactive protein
timeFrame: Preoperative 3 days and postoperative 1, 3, and 7 days
measure: The variation of interleukin-6(IL-6)
timeFrame: Preoperative 3 days and postoperative 1, 3, and 7 days
measure: The variation of interleukin-10(IL-10)
timeFrame: Preoperative 3 days and postoperative 1, 3, and 7 days
measure: The variation of cortisol
timeFrame: Preoperative 3 days and postoperative 1, 3, and 7 days
measure: The variation of lymphocyte subsets count of CD3, CD4 and CD8
timeFrame: Preoperative 3 days and postoperative 1, 3, and 7 days
measure: The positive rate of malignant cells in ascitic fluid specimen
timeFrame: 1 day
measure: The positive rate of bacterial culture in ascitic fluid specimen
timeFrame: 1 day
measure: Postoperative pain score
timeFrame: 1 day
measure: Time to first flatus
timeFrame: 30 days
measure: Time to leave bed postoperatively
timeFrame: 30 days
measure: Time to first liquid diet postoperatively
timeFrame: 30 days
measure: Postoperative hospital stay
timeFrame: 30 days
measure: Operation time
timeFrame: 1 day
measure: Estimated blood loss
timeFrame: 1 day
measure: Number of retrieved lymph nodes
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital (301 Hospital) China
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical College
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of General Surgery, The First Affiliated Hospital of Nanchang University
name: Taiyuan Li, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo R, Zheng F, Zhang H, Zhu W, He P, Liu D. Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial. Trials. 2021 Feb 6;22(1):121. doi: 10.1186/s13063-021-05077-z.