Quality of Life After Transanal Endoscopic Microsurgery (TEM) (QoLTEM)

January 26, 2022 updated by: State Scientific Centre of Coloproctology, Russian Federation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 123423
        • State Scientific Centre of Coloproctology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rectal neoplasms with planning transanal endoscopic microsurgery (TEM)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month
Sphinctrometry
Time Frame: 3 month
Anal pressure in mmHg
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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