HemorrhoidsPhase 4NCT00841620
Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids
A Phase 4 study testing Haemorrhoidectomy a.m. Milligan and Stapled anopexy in people with Hemorrhoids, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids. Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Haemorrhoidectomy a.m. Milligan and Stapled anopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 1999to Apr 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grades III and IV haemorrhoids
Who cannot join
- Previous operation for high anal fistula or injury to the anal sphincteres
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial
Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.
Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.
- Conditions
- Hemorrhoids
- Being tested
- Haemorrhoidectomy a.m. Milligan, Stapled anopexy
- Keywords
- Symptoms, Postoperative pain, Postoperative complications, Milligan, Anopxy
- Medical subject headings
- Hemorrhoids, Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemorrhoidectomy a.m. MilliganProcedure or surgery
Surgery
Stapled anopexyProcedure or surgery
Surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Haemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids Receives: Procedure: Haemorrhoidectomy a.m. Milligan |
| 2 | Active comparator | Stapled anopexy for grade 3-4 haemorrhoids Receives: Procedure: Stapled anopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported frequency of symptoms
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startSep 1999
- Primary completionJan 2001
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, Niels Qvist, Odense University Hospital
- Investigators
- Niels Qvist, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841620
- Sponsor's protocol ID
- STOPP
- Status last verified
- Apr 2015
- First submitted
- 10 Feb 2009
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Control 1-year After Circular Stapler Anopey or Diathermy Excision for Prolapsed Haemorrhoids: an International Randomsed Trial (the STOPP-trial
- ClinicalTrials.gov ID
- NCT00841620
- Acronym / sponsor ID
- STOPP
- Conditions
- Hemorrhoids
- Keywords
- Symptoms, Postoperative pain, Postoperative complications, Milligan, Anopxy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Oxford University Hospitals NHS Trust
- Study start
- Sep 1999
- Primary completion
- Jan 2001 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Feb 2009 (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.
Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.
Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Haemorrhoidectomy a.m. MilliganHaemorrhoidectomy a.m. Milligan for grade 3-4 haemorrhoids |
| 2 | Active comparator | Procedure: Stapled anopexyStapled anopexy for grade 3-4 haemorrhoids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grades III and IV haemorrhoids
Key exclusion criteria (1 listed)
- Previous operation for high anal fistula or injury to the anal sphincteres
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 |
|---|---|---|
| Haemorrhoidectomy a.m. MilliganSurgery | Procedure or surgery | 1 |
| Stapled anopexySurgery | Procedure or surgery | 2 |
Primary outcome
Self-reported frequency of symptoms
Time frame: one year
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 4 May 2015.
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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.
Niels Qvist, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haemorrhoidectomy a.m. Milligan and Stapled anopexy in people with Hemorrhoids, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 4 May 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-reported frequency of symptoms (time frame: one year). 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 4 May 2015.