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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    550
  • sponsor
    Taiyuan Li
Updated on 24 January 2021
metastasis
primary cancer
adenocarcinoma
colorectal adenocarcinoma

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.

Details
Condition Colorectal Cancer, Rectal disorder, Cancer, Colon Cancer Screening, Cancer/Tumors, Rectal Disorders, Colon cancer; rectal cancer, Ewing's Family Tumors, Complication of Surgical Procedure, Robotic Surgical Procedures, Cancer (Pediatric), Neoplasms, Natural Orifice Specimen Extraction Surgery, colorectal neoplasm, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Natural Orifice Specimen Extraction Surgery, Natural Orifice Specimen Extraction Surgery, Traditional Robotic-assisted Surgery
Clinical Study IdentifierNCT04230772
SponsorTaiyuan Li
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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