Transanal Stapled AnastomosisNCT05992948
Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis
An observational study of Transanal Stapled Anastomosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Transanal Stapled Anastomosis
- What is being tested?
- Transanal stapling device
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2020to 1 Jan 2025
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients requiring transanal stapled anastomosis due to various reasons will be enrolled in this study.
Who may be able to join
- Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna
- Ability and willingness to understand and comply with study interventions and restrictions.
- Voluntarily signed informed consent after full explanation of the study to the participant.
Who cannot join
- Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
- Inability to communicate well with the investigator due to language problems or reduced mental development
- Inability or unwillingness to give written informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Christopher Dawoud, MD, +43 660 280 48 39, christopher.dawoud@meduniwien.ac.at
Stefan Riss, Prof.MD, +43 1 40400 56210, stefan.riss@meduniwien.ac.at
About this study
Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.
- Conditions
- Transanal Stapled Anastomosis
- Being tested
- Transanal stapling device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal stapling deviceDevice
Transanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations
What is being measured
The primary outcome is the main question the study is designed to answer.
EAUS
Change in thickness of the anal sphincter muscles in mm from baseline to 3 months
Measured: 3 months postoperative
Secondary outcomes (5)
Endoanal manometry
Change in Anal pressure in mmHg from baseline to 3 months
Measured: 3 months postoperative
EAUS2
Change in the defect grade of anal sphincter muscles from baseline to 3 months
Measured: 3 months postoperative
EAUS2-2
Change in thickness of the anal sphincter muscles in mm from baseline to 12 months
Measured: 12 months postoperative
EAUS2-2
Change in the defect grade of anal sphincter muscles from baseline to 12 months
Measured: 12 months postoperative
Endoanal manometry2
Change in Anal pressure in mmHg from baseline to 12 months
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jan 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transanal Stapled AnastomosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Dawoud, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992948
- Sponsor's protocol ID
- 2192/2019
- Status last verified
- Aug 2023
- First submitted
- 27 Mar 2023
- Last updated
- 15 Aug 2023
- Results posted
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis
- ClinicalTrials.gov ID
- NCT05992948
- Acronym / sponsor ID
- 2192/2019
- Conditions
- Transanal Stapled Anastomosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring transanal stapled anastomosis due to various reasons will be enrolled in this study.
Key inclusion criteria (3 listed)
- Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna
- Ability and willingness to understand and comply with study interventions and restrictions.
- Voluntarily signed informed consent after full explanation of the study to the participant.
Key exclusion criteria (3 listed)
- Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
- Inability to communicate well with the investigator due to language problems or reduced mental development
- Inability or unwillingness to give written informed consent
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 |
|---|---|---|
| Transanal stapling deviceTransanal stapling device used in low anterior- or anterior rectum resection, sigma resection, left hemicolectomy and intestinal reconstruction operations | Device | – |
Primary outcome
EAUS
Time frame: 3 months postoperative
Change in thickness of the anal sphincter muscles in mm from baseline to 3 months
5 secondary outcomes
Endoanal manometry
Time frame: 3 months postoperative
EAUS2
Time frame: 3 months postoperative
EAUS2-2
Time frame: 12 months postoperative
EAUS2-2
Time frame: 12 months postoperative
Endoanal manometry2
Time frame: 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- 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.
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 Stapled Anastomosis, run by Medical University of Vienna at 1 site in Austria.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Dawoud, MD (0043 1 40400 56220, christopher.dawoud@muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EAUS (time frame: 3 months postoperative). 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 15 Aug 2023.