Quality of Life After Transanal Endoscopic Microsurgery (TEM)

Transanal Endoscopic Microsurgery (TEM) Clinical Trial

— QoLTEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675243
• Other study ID #: 85A
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2022
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Transanal Endoscopic Microsurgery (TEM)

Intervention

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

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal incontinence quality of life scale	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	Wexner score	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
Secondary	Sphinctrometry	Anal pressure in mmHg	3 month