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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675243
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Transanal Endoscopic Microsurgery (TEM) Diagnostic Test: sphincterometry

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life After Transanal Endoscopic Microsurgery (TEM) for Rectal Neoplasm
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy


Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Sphinctrometry [ Time Frame: 3 month ]
    Anal pressure in mmHg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rectal neoplasms with planning transanal endoscopic microsurgery (TEM)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675243


Contacts
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Contact: Evgeny Rybakov, MD +7 499 199 86 43 erybakov@gmail.com

Locations
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Russian Federation
State Scientific Centre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Contact: Stanislav Chernyshov, MD       stchernyshov@gmail.com   
Sub-Investigator: Evgeniy Khomyakov, PhD         
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation
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Responsible Party: State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT03675243    
Other Study ID Numbers: 85A
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by State Scientific Centre of Coloproctology, Russian Federation:
Transanal endoscopic microsurgery
TEM
QoL
quality of life
rectal cancer
rectal surgery
rectal neoplasm
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases