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Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

NCT ID: NCT06380855

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-24

Study Completion Date

2025-08-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Flexible colonoscope assisted taTME group

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

Flexible colonoscope assisted hybrid transanal total mesorectal resection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yanhong Deng

Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liang Kang, MD. and Phd.

Role: CONTACT

[email protected]
020-38455369

Facility Contacts

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Liang Kang, MD, PhD

Role: primary

[email protected]
008613602886833

Other Identifiers

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GIHSYSU-34

Identifier Type: -

Identifier Source: org_study_id

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