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NCT06380855 Clinical Trial

Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

Rectal Cancer Clinical Trial

Official title:
Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06380855
Other study ID # GIHSYSU-34
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 24, 2022
Est. completion date August 24, 2025

Study information
Verified date April 2024
Source Sun Yat-sen University
Contact Liang Kang, MD. and Phd.
Phone 020-38455369
Email kangl@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury.

Description:

Endoscopic technique has become an indispensable part of Natural orifice transluminal endoscopic surgery (NOTES). However, the upper gastrointestinal tract is easy to cause severe leakage complications, which mainly limits the application of endoscopy in rectum. Herein, investigators propose purse suture closing distal rectum and full-layer incision of the rectal wall using flexible endoscopic from anal to assist in hybrid transanal total mesorectal resection (taTME).Further reduce the damage of anus caused by taTME.

Recruitment information / eligibility
Status Recruiting
Enrollment 5
Est. completion date August 24, 2025
Est. primary completion date August 24, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Age between 18 and 80 years old 2. Confirmed rectal adenocarcinoma cancer pathologically 3. tumor location ? 12 cm from the anal margin 4. Willing and able to provide written informed consent for participation in this study Exclusion Criteria: 1. distant metastasis before surgery 2. more than one colorectal tumor at diagnosis 3. familial adenomatous polyposis 4. recurrent rectal cancer 5. undergo transanal minimally invasive surgery 6. undergo palliative treatment 7. undergo emergency surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Flexible colonoscope assisted hybrid transanal total mesorectal resection
Endoscopic pursestring suture (EPSS) was performed at the distance from 1cm to the inferior edge of the tumor by a double-channel flexible colonoscope. An endoloop was inserted through one channel. Meanwhile, the endoclips was inserted through the other channel one by one to fix the endoloop around the rectal wall. And then the endoloop was tightened slowly. After completing the routine lavage lumen, a full-thickness, circumferential dissection was performed by flexible colonoscope following taTME surgical principle until it converged with the laparoscopy group.

Locations
Country Name City State
China Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Success rate of operation Whether it is necessary to switch to other surgical methods 1 years after the surgery
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