Constipation, Impaction, and Bowel ObstructionNCT06522399
Outcome of TAMIS Mucosal Resection in Patients With ODS
An observational study of Constipation, Impaction, and Bowel Obstruction and TAMIS Mucosectomy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Constipation, Impaction, and Bowel Obstruction, TAMIS Mucosectomy, Obstructed Defecation Syndrome
- What is being tested?
- TAMIS mucosectomy
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2021to 1 Oct 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled who ungergo minimally invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
Who may be able to join
- Need of minimal invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
- Age: 18-90 years
- Ability and willingness to understand and comply with planned interventions during the study.
- Voluntarily signed informed consent after a full explanation of the study to the participant.
Who cannot join
- Any physical or mental disorder 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.
About this study
Official title: Outcome of Transanal Minimally Invasive (TAMIS) Mucosal Resection in Patients With Obstructed Defecation Syndrome - a Pilot Study
Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study.
Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score.
Read the detailed description
Various surgical approaches for the treatment of obstructed defecation syndrome (ODS) commonly associated with rectocele and rectal intussusception have been investigated in the literature. Methods such as stapled transanal resection of the rectum (STARR) and ventral prosthesis rectopexy (VPR) show promising results at least in the short term. In the long-term, however, the results do not seem convincing. Schiano di Visconte et al. report a recurrence of ODS symptoms in 40 percent of the patients, treated with stapled transanal rectal resection in a 10-year follow up. The clinical outcome of surgical treatment of ODS using transanal minimally invasive surgery (TAMIS) in the sense of a mucosal resection without stapling technique has not yet been investigated. This project is designed to show the short-term outcome of non-stapled mucosal resection through TAMIS.
- Conditions
- Constipation, Impaction, and Bowel Obstruction, TAMIS Mucosectomy, Obstructed Defecation Syndrome
- Being tested
- TAMIS mucosectomy
- Keywords
- obstructed defecation syndrome, TAMIS mucosectomy
- Medical subject headings
- Constipation, Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAMIS mucosectomyProcedure or surgery
internal Delorme's procedure using TAMIS
| Study group | Role | What they receive |
|---|---|---|
| patients with obstructed defecation who undergo TAMIS mucosectomy | patients with obstructed defecation and rectocele or intussuception Receives: Procedure: TAMIS mucosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome assessment
functional outcome defined by ODS score
Measured: 6 months
Secondary outcomes (2)
fecal incontinence assessment
fecal incontinence improvement or worsening measured by using the VAIZEY Score
Measured: 6 months
Quality of life assessment
Health-related quality of life after TAMIS in ODS patients, defined by Quality of Life Score (SF12).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation, Impaction, and Bowel ObstructionStudies 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
- Retrospective
- Enrolment
- 11 participants (actual)
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
- Investigators
- Stefan Riss, MD, Study chair, Medical University of Vienna, Head of Pelvic Floor surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522399
- Sponsor's protocol ID
- 1415/2022
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared just in anonymised form in case of an ethical agreement with other researchers.
Publications
Widmann KM, Dawoud C, Gidl D, Riss S. Transanal minimally invasive (TAMIS) mucosal resection with muscular plication for patients with obstructed defecation syndrome-A prospective pilot study. Tech Coloproctol. 2025 Feb 21;29(1):71. doi: 10.1007/s10151-024-03101-3.
PubMed 39984789
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Transanal Minimally Invasive (TAMIS) Mucosal Resection in Patients With Obstructed Defecation Syndrome - a Pilot Study
- ClinicalTrials.gov ID
- NCT06522399
- Acronym / sponsor ID
- 1415/2022
- Conditions
- Constipation, Impaction, and Bowel Obstruction, TAMIS Mucosectomy, Obstructed Defecation Syndrome
- Keywords
- obstructed defecation syndrome, TAMIS mucosectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Jul 2024 (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.
Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study.
Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score.
Detailed description
Various surgical approaches for the treatment of obstructed defecation syndrome (ODS) commonly associated with rectocele and rectal intussusception have been investigated in the literature. Methods such as stapled transanal resection of the rectum (STARR) and ventral prosthesis rectopexy (VPR) show promising results at least in the short term. In the long-term, however, the results do not seem convincing. Schiano di Visconte et al. report a recurrence of ODS symptoms in 40 percent of the patients, treated with stapled transanal rectal resection in a 10-year follow up. The clinical outcome of surgical treatment of ODS using transanal minimally invasive surgery (TAMIS) in the sense of a mucosal resection without stapling technique has not yet been investigated. This project is designed to show the short-term outcome of non-stapled mucosal resection through TAMIS.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with obstructed defecation who undergo TAMIS mucosectomy | – | Procedure: TAMIS mucosectomypatients with obstructed defecation and rectocele or intussuception |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled who ungergo minimally invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
Key inclusion criteria (4 listed)
- Need of minimal invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
- Age: 18-90 years
- Ability and willingness to understand and comply with planned interventions during the study.
- Voluntarily signed informed consent after a full explanation of the study to the participant.
Key exclusion criteria (3 listed)
- Any physical or mental disorder 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 |
|---|---|---|
| TAMIS mucosectomyinternal Delorme's procedure using TAMIS | Procedure or surgery | patients with obstructed defecation who undergo TAMIS mucosectomy |
Primary outcome
functional outcome assessment
Time frame: 6 months
functional outcome defined by ODS score
2 secondary outcomes
fecal incontinence assessment
Time frame: 6 months
Quality of life assessment
Time frame: 6 months
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 26 Jul 2024.
- Derived from this study: PubMed 39984789Widmann KM, Dawoud C, Gidl D, Riss S. Transanal minimally invasive (TAMIS) mucosal resection with muscular plication for patients with obstructed defecation syndrome-A prospective pilot study. Tech Coloproctol. 2025 Feb 21;29(1):71. doi: 10.1007/s10151-024-03101-3.
- Individual participant dataSharing planned: No. IPD can be shared just in anonymised form in case of an ethical agreement with other researchers.
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.
Stefan Riss, MD study chair
Medical University of Vienna, Head of Pelvic Floor surgery
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 Constipation, Impaction, and Bowel Obstruction and TAMIS Mucosectomy, 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 4 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 26 Jul 2024. 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?
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?
functional outcome assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06522399, which also lists 1 linked publication.
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 26 Jul 2024.