HaemorrhoidsNCT01301209
Recto-Anal-Repair in the Treatment of Advanced Haemorrhoidal Disease
An observational study of Haemorrhoids, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemorrhoids
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2007to Dec 2007
- 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 haemorrhoids stage III/IV
Who may be able to join
- Stage III or IV hemorrhoidal disease (Appendix A)
- Patient age 18-80 years old
- Patient fit for general or local anesthesia
- No prior surgical treatment for hemorrhoidal disease
- No prior surgical treatment for anorectal sepsis
- Signed informed consent
Who cannot join
- Stage I or II hemorrhoidal disease (Appendix A)
- Patient unfit for surgery
- Clotting disorders
- Anal or colorectal malignancy
- Secondary hemorrhoidal disease
- Pregnancy
- Unwilling or unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Surgery, Medical University Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Prospective Observational Study of Recto-Anal-Repair in the Treatment Haemorrhoidal Disease Stage III/IV
Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal disease.
- Conditions
- Haemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| treatment | patients undergoing treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Sebastian Roka, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301209
- Sponsor's protocol ID
- 078/2006
- Status last verified
- Jun 2006
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Recto-Anal-Repair in the Treatment Haemorrhoidal Disease Stage III/IV
- ClinicalTrials.gov ID
- NCT01301209
- Acronym / sponsor ID
- 078/2006
- Conditions
- Haemorrhoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Feb 2011 (estimated)
- 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.
Prospective observational study to evaluate the impact of Recto-Anal-Repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage III/IV haemorrhoidal disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | – | –patients undergoing treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with haemorrhoids stage III/IV
Key inclusion criteria (6 listed)
- Stage III or IV hemorrhoidal disease (Appendix A)
- Patient age 18-80 years old
- Patient fit for general or local anesthesia
- No prior surgical treatment for hemorrhoidal disease
- No prior surgical treatment for anorectal sepsis
Key exclusion criteria (7 listed)
- Stage I or II hemorrhoidal disease (Appendix A)
- Patient unfit for surgery
- Clotting disorders
- Anal or colorectal malignancy
- Secondary hemorrhoidal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Feb 2011.
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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.
Sebastian Roka, MD principal investigator
Medical University of Vienna
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 Haemorrhoids, 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 6 inclusion and 7 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 23 Feb 2011. 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.
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 23 Feb 2011.