NCT03675243

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

September 12, 2018

Last Update Submit

January 26, 2022

Conditions

Transanal Endoscopic Microsurgery (TEM)

Keywords

Transanal endoscopic microsurgeryTEMQoLquality of liferectal cancerrectal surgeryrectal neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Wexner score

    3 month

  • Sphinctrometry

    3 month

Interventions

sphincterometryDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Have a planned of Transanal endoscopic microsurgery (TEM)
  • Have signed approved informed consent form for the study

You may not qualify if:

  • non epithelial malignancy
  • recurrent neoplasm
  • stoma formation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 18, 2018

Study Start

April 1, 2018

Primary Completion

March 30, 2020

Study Completion

March 30, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)