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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Natural Orifice Specimen Extraction Surgery
* Procedure: Traditional Robotic-assisted Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 80 years; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale; Histological or cytological confirmation of colorectal adenocarcinoma; High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line; 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; Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs; Cardiopulmonary liver and kidney function can withstand surgery; Written informed consent for participation in the trial. Exclusion Criteria: Not suitable for robot laparoscopic surgery; The tumor is too large to be pulled out through the anus or vagina; Simultaneous multiple primary cancer; Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer Women with acute gynecological infections, vaginal deformities, unmarried and infertile women and women who are married and plan to get pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Natural Orifice Specimen Extraction Surgery<br>Natural orifice specimen extraction surgery will performed in patients assigned to this group. | Procedure: Natural Orifice Specimen Extraction Surgery<br>* In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.<br>|
| Active Comparator: Traditional Robotic-assisted Surgery<br>Traditional robotic-assisted surgery will performed in patients assigned to this group. | Procedure: Traditional Robotic-assisted Surgery<br>* In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical complications | 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 | 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) | 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) | 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 | 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 | 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 | 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 | Ascitic fluid specimen will be taken after surgery and tested by clinical laboratory. | 1 day | 
| Postoperative pain score | Postoperative pain score will be assessed by visual analog score. | 1 day | 
| Time to first flatus | Time to first flatus is used to assess the postoperative recovery course | 30 days | 
| Time to leave bed postoperatively | 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 to first liquid diet postoperatively in days is used to assess the postoperative recovery course. | 30 days | 
| Postoperative hospital stay | Postoperative hospital stay is used to assess the postoperative recovery course. | 30 days | 
| Operation time | Time from start of incision to finish of abdominal closure. | 1 day | 
| 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 | 
| Number of retrieved lymph nodes | Number of retrieved lymph nodes will be determined according to the pathological report. | 1 day |