Quality of Life After Transanal Endoscopic Microsurgery (TEM)

NCT ID: NCT03675243

Last Updated: 2022-01-27

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-03-30

Brief Summary

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This is a observational cohort study to determine the influence of Transanal endoscopic microsurgery (TEM) on patients Quality of Life

Detailed Description

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Patients who planning Transanal Endoscopic Microsurgery (TEM) for rectal neoplasms should undergoing fecal incontinence quality of life scale and Wexner score before and after surgery for measurement their quality of life. For objectification data sphinctrometry will be perform.

Conditions

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Transanal Endoscopic Microsurgery (TEM)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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sphincterometry

Sphincterometry is a method of the spincter function examination, which allows to assess the state of the anal sphincter muscle and its function

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Have a planned of Transanal endoscopic microsurgery (TEM)
* Have signed approved informed consent form for the study

Exclusion Criteria

* non epithelial malignancy
* recurrent neoplasm
* stoma formation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Scientific Centre of Coloproctology

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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85A

Identifier Type: -

Identifier Source: org_study_id

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