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Clinical Trials/NCT03675243
NCT03675243
Completed
Not Applicable

Quality of Life After Transanal Endoscopic Microsurgery (TEM) for Rectal Neoplasm

State Scientific Centre of Coloproctology, Russian Federation1 site in 1 country100 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transanal Endoscopic Microsurgery (TEM)
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
Enrollment
100
Locations
1
Primary Endpoint
Fecal incontinence quality of life scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
March 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
State Scientific Centre of Coloproctology, Russian Federation
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fecal incontinence quality of life scale

Time Frame: 3 month

The FIQL is a standardized instrument that can be used to assess QOL issues related to fecal incontinence.The Fecal Incontinence Quality of Life Scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items).Each aspect is described as a score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected

Secondary Outcomes

  • Wexner score(3 month)
  • Sphinctrometry(3 month)

Study Sites (1)

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