Transanal Endoscopic Microsurgery (TEM)QoLTEMNCT03675243
Quality of Life After Transanal Endoscopic Microsurgery (TEM)
An observational study of Transanal Endoscopic Microsurgery (TEM), run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
This is a observational cohort study to determine the influence of Transanal endoscopic microsurgery (TEM) on patients Quality of Life Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transanal Endoscopic Microsurgery (TEM)
- What is being tested?
- sphincterometry
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2018to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rectal neoplasms with planning transanal endoscopic microsurgery (TEM)
Who may be able to join
- Have a planned of Transanal endoscopic microsurgery (TEM)
- Have signed approved informed consent form for the study
Who cannot join
- non epithelial malignancy
- recurrent neoplasm
- stoma formation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Transanal Endoscopic Microsurgery (TEM) for Rectal Neoplasm
This is a observational cohort study to determine the influence of Transanal endoscopic microsurgery (TEM) on patients Quality of Life
Read the 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.
- Conditions
- Transanal Endoscopic Microsurgery (TEM)
- Being tested
- sphincterometry
- Keywords
- Transanal endoscopic microsurgery, TEM, QoL, quality of life, rectal cancer, rectal surgery, rectal neoplasm
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Secondary outcomes (2)
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.
Measured: 3 month
Sphinctrometry
Anal pressure in mmHg
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Apr 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transanal Endoscopic Microsurgery (TEM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675243
- Sponsor's protocol ID
- 85A
- Acronym
- QoLTEM
- Status last verified
- Jan 2022
- First submitted
- 12 Sep 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Transanal Endoscopic Microsurgery (TEM) for Rectal Neoplasm
- ClinicalTrials.gov ID
- NCT03675243
- Acronym / sponsor ID
- QoLTEM / 85A
- Conditions
- Transanal Endoscopic Microsurgery (TEM)
- Keywords
- Transanal endoscopic microsurgery, TEM, QoL, quality of life, rectal cancer, rectal surgery, rectal neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rectal neoplasms with planning transanal endoscopic microsurgery (TEM)
Key inclusion criteria (2 listed)
- Have a planned of Transanal endoscopic microsurgery (TEM)
- Have signed approved informed consent form for the study
Key exclusion criteria (3 listed)
- non epithelial malignancy
- recurrent neoplasm
- stoma formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sphincterometrySphincterometry is a method of the spincter function examination, which allows to assess the state of the anal sphincter muscle and its function | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Wexner score
Time frame: 3 month
Sphinctrometry
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transanal Endoscopic Microsurgery (TEM), run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal incontinence quality of life scale (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.