Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

Recruiting

• Conditions: Rectal Cancer
• Interventions: Procedure: Flexible colonoscope assisted hybrid transanal total mesorectal resection

• Registration Number: NCT06380855
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-08-24
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-08-24
• Study Completion: 2025-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Success rate of operation	1 years after the surgery	Whether it is necessary to switch to other surgical methods

Trial Locations

Locations (1)

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China