Quality of Life After Transanal Endoscopic Microsurgery (TEM)

Completed

• Conditions: Transanal Endoscopic Microsurgery (TEM)

• Registration Number: NCT03675243
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-16
• Study First Posted: 2018-09-18
• Primary Completion: 2020-03-30
• Study Completion: 2021-03-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fecal incontinence quality of life scale	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 Outcome Measures

Name	Time	Method
Wexner score	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.
Sphinctrometry	3 month	Anal pressure in mmHg

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation