the Value of Transanal Endoscopic ISR

NCT ID: NCT05933785

Last Updated: 2024-03-07

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

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2023-05-30

Brief Summary

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The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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transanal endoscopic ISR

transanal endoscopic ISR

Intervention Type PROCEDURE

perform ISR using laparoscopy through transanal port

traditional ISR

No interventions assigned to this group

Interventions

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transanal endoscopic ISR

perform ISR using laparoscopy through transanal port

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of rectal carcinoma
* preoperative stage as (y) cT1-3N0-2M0
* lower margin of the tumor less than 5cm from the anus
* tumor diameter ≤5cm

Exclusion Criteria

* Pregnant or lactating women
* Synchronous rectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Emergency procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital

Shanghai, , China

Site Status

Shanghai Minimally Invasive Surgery Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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taE-ISR

Identifier Type: -

Identifier Source: org_study_id

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