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Natural Orifice Specimen Extraction Surgery for Colorectal Cancer

NCT05740267 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2023-02-23

No results posted yet for this study

Summary

The goal of this type of study: a prospective, randomized controlled clinical trial is to assess the safety and feasibility of NOSE surgery to compare the NOSE and conventional laparoscopy groups in Colorectal cancer patients. The main questions it aims to answer are measuring the postoperative inflammatory response and monitoring the early morbidity and mortality rate after surgery. Participants will be assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection. If there is a comparison group: Researchers will compare the control group to see if postoperative inflammatory response.

Conditions

Interventions

PROCEDURE

Natural Orifice Specimen Extraction

After bowel resection, all bowel anastomoses are created via side-to-side intracorporeal anastomosis, either isoperistaltic or antiperistaltic. The surgical steps of NOSE with the transrectal method are illustrated in Figure 1. First, the rectosigmoid colonic lumen is blocked with a bowel clamp. After rectal irrigation with povidone-iodine water, a transanal endoscopic microsurgery (TEM) scope or Alexis wound protector is inserted through the anus, reaching the upper rectum. Enterotomy is performed at the upper rectum, and a suction device is used to clean any fecal spillage. The TEM scope is pushed forward beyond the rectal opening, and the specimen is extracted with the TEM scope. The rectal opening is closed with a barbed suture, and an air leak test is performed to identify anastomotic leakage.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jeng-Fu You · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-11-30
Completion
2025-11-30

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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 NCT05740267 on ClinicalTrials.gov