Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

NCT06380855 | Recruiting

• 1 other identifier: GIHSYSU-34
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Success rate of operation

  Whether it is necessary to switch to other surgical methods

  1 years after the surgery

Study Arms (1)

Flexible colonoscope assisted taTME group

Flexible colonoscope assisted hybrid transanal total mesorectal resection (taTME) group

Procedure: Flexible colonoscope assisted hybrid transanal total mesorectal resection

Interventions

Flexible colonoscope assisted hybrid transanal total mesorectal resection PROCEDURE

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.

Flexible colonoscope assisted taTME group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients suitable for transanal endoscopic surgery

You may qualify if:

• Age between 18 and 80 years old
• Confirmed rectal adenocarcinoma cancer pathologically
• tumor location ≦ 12 cm from the anal margin
• Willing and able to provide written informed consent for participation in this study

You may not qualify if:

• distant metastasis before surgery
• more than one colorectal tumor at diagnosis
• familial adenomatous polyposis
• recurrent rectal cancer
• undergo transanal minimally invasive surgery
• undergo palliative treatment
• undergo emergency surgery

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Liang Kang, MD. and Phd.

CONTACT

020-38455369; kangl@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: August 24, 2022
• Primary Completion: August 24, 2025
• Study Completion: August 24, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CN (1)