Quality of Life After Transanal Endoscopic Microsurgery (TEM)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03675243

Acronym

QoLTEM

Enrollment

100

Registered

2018-09-18

Start date

2018-04-01

Completion date

2021-03-30

Last updated

2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transanal Endoscopic Microsurgery (TEM)

Keywords

Transanal endoscopic microsurgery, TEM, QoL, quality of life, rectal cancer, rectal surgery, rectal neoplasm

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.

Interventions

DIAGNOSTIC_TESTsphincterometry

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026