CClinicalTrials.gg
RecruitingNCT06380855Updated Apr 24, 2024

Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

An observational study in Rectal Cancer, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
5
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Rectal Cancer

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 5 is below the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients suitable for transanal endoscopic surgery

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
5 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureFlexible 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.

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What researchers measure

Primary outcomes

  1. Success rate of operation

    Whether it is necessary to switch to other surgical methods

    Time frame: 1 years after the surgery

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Study locations

1 of 1 sites recruiting
  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06380855
Lead sponsor
Sun Yat-sen University
Responsible party
Yanhong Deng (Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME), Sun Yat-sen University) — Principal investigator
First posted
Apr 24, 2024
Start date
Aug 24, 2022
Primary completion
Aug 24, 2025 (estimated)
Completion
Aug 24, 2025 (estimated)
Last update
Apr 24, 2024

Study contacts

Liang Kang, MD. and Phd.
Contact
kangl@mail.sysu.edu.cn
020-38455369

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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