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Completed

NCT Number: NCT03675243

Quality of Life After Transanal Endoscopic Microsurgery (TEM)

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

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Key information

Conditions

Transanal Endoscopic Microsurgery (TEM) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sphincterometry

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Wexner score

    Time frame: 3 month

    Wexner score is composed of a total 5 items for each type of incontinence. Each aspect is described as a score measured on a scale between 1 and 4, where 0 is rarely, 4 - always/ 0 - perfect, 20 - complete incontinence.

  2. Sphinctrometry

    Time frame: 3 month

    Anal pressure in mmHg

Sponsors and collaborators

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Other Gov

Registry information

Official study title

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

Acronym: QoLTEM

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 18, 2018
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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