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A Randomized, Controlled, Multicenter, Noninferiority Clinical Study of Perioperative and Oncological Safety in Patients With Rectal Cancer

NCT05503381 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-08-16

No results posted yet for this study

Summary

Laparoscopic natural orifice specimen extraction surgery (NOSES) for low rectal cancer has a good minimally invasive effect. However, the NOSES prognosis studies are all small sample retrospective studies. This study conducted a multicenter prospective randomized controlled trial of NOSES surgery for low rectal cancer to compare the difference in surgical outcomes between conventional laparoscopic surgery and NOSES surgery for low rectal cancer. A total of 500 patients were planned to be enrolled, including 250 in the control group and 250 in the experimental group. The primary end point was 2-year disease-free survival (DFS), and the secondary end points were surgical safety, postoperative pathology, postoperative defecation, urination, and sexual function. Through a large sample size study, this study aims to clarify the advantages of NOSE surgery for low rectal cancer, promote the promotion of low rectal cancer NOSES surgery in the country, standardize the way of low rectal cancer NOSES surgery, improve the surgical treatment of patients with low rectal cancer, improve the quality of life of patients, reduce the burden of patients, and increase the satisfaction. And improve the international influence of the project team in the field of minimally invasive surgical treatment of colorectal cancer.

Conditions

  • Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University

Interventions

PROCEDURE

Laparoscopic radical resection of low rectal cancer with transanal specimens

According to the standard laparoscopic anterior rectum resection, the rectum was separated 2-3cm below the tumor, the rectum was severed 1-2cm from the lower edge of the tumor, the rectal stump was connected with the tumor through the anus, and the sigmoid colon was severed 10cm from the upper edge of the tumor. The stapler head was placed in the sigmoid colon stump, and then the sigmoid colon stump was closed with a linear cutting closure device. Then, the sigmoid colon stump is returned to the abdominal cavity through the anus, the distal rectal stump is closed with a suture purse or a linear cutting closure device, and the stapler body is inserted through the anus, and then the anastomosis is completed.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05503381 on ClinicalTrials.gov