Internal HemorrhoidsPhase 3NCT01533363
Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
A Phase 3 study testing Stapled hemorrhoidopexy and Milligan Morgan in people with Internal Hemorrhoids, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Internal Hemorrhoids
- What is being tested?
- Stapled hemorrhoidopexy and Milligan Morgan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Sep 2007
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- third degree circular hemorrhoids
- symptomatic
- reducible
Who cannot join
- single third-degree hemorrhoids
- acute incarcerated hemorrhoids
- intercurrent acute anal fissure
- acute anal fistula
- prior hemorrhoidectomy.
About this study
Official title: Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.
Read the detailed description
There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available.
In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.
- Conditions
- Internal Hemorrhoids
- Being tested
- Stapled hemorrhoidopexy, Milligan Morgan
- Keywords
- Hemorrhoids, Surgery, Hemorrhoidopexy, Milligan Morgan
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled hemorrhoidopexyProcedure or surgery
Also called Ethicon PPH 01
Milligan MorganProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stapled hemorrhoidopexy | Active comparator | surgical procedure to treat hemorrhoids Receives: Procedure: Stapled hemorrhoidopexy |
| Milligan Morgan | Active comparator | surgical procedure to treat hemorrhoids Receives: Procedure: Milligan Morgan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Measured: within the first 30 days after surgery
Secondary outcomes (1)
long-term recurrence rate
Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years. Postoperative morbidity such as bleeding, wound infection, urinary retention, and itching and burning, and transient incontinence symptoms, and parameters such as length of hospital stay and operating time were evaluated
Measured: up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startJul 2000
- Primary completionSep 2007
- Study completionSep 2007
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 Internal HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Asad Kutup, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Jakob R Izbicki, MD, Study chair, Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533363
- Sponsor's protocol ID
- 1612
- Status last verified
- Feb 2012
- First submitted
- 5 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gravie JF, Lehur PA, Huten N, Papillon M, Fantoli M, Descottes B, Pessaux P, Arnaud JP. Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up. Ann Surg. 2005 Jul;242(1):29-35. doi: 10.1097/01.sla.0000169570.64579.31.
PubMed 15973098
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01533363
- Acronym / sponsor ID
- 1612
- Conditions
- Internal Hemorrhoids
- Keywords
- Hemorrhoids, Surgery, Hemorrhoidopexy, Milligan Morgan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 15 Feb 2012 (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.
The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.
Detailed description
There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available.
In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapled hemorrhoidopexy | Active comparator | Procedure: Stapled hemorrhoidopexysurgical procedure to treat hemorrhoids |
| Milligan Morgan | Active comparator | Procedure: Milligan Morgansurgical procedure to treat hemorrhoids |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- third degree circular hemorrhoids
- symptomatic
- reducible
Key exclusion criteria (5 listed)
- single third-degree hemorrhoids
- acute incarcerated hemorrhoids
- intercurrent acute anal fissure
- acute anal fistula
- prior hemorrhoidectomy.
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 |
|---|---|---|
| Stapled hemorrhoidopexyAlso: Ethicon PPH 01 | Procedure or surgery | Stapled hemorrhoidopexy |
| Milligan Morgan | Procedure or surgery | Milligan Morgan |
Primary outcome
Postoperative Pain
Time frame: within the first 30 days after surgery
1 secondary outcome
long-term recurrence rate
Time frame: up to 5 years after surgery
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 15 Feb 2012.
- Background: PubMed 15973098Gravie JF, Lehur PA, Huten N, Papillon M, Fantoli M, Descottes B, Pessaux P, Arnaud JP. Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up. Ann Surg. 2005 Jul;242(1):29-35. doi: 10.1097/01.sla.0000169570.64579.31.
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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.
Jakob R Izbicki, MD study chair
Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stapled hemorrhoidopexy and Milligan Morgan in people with Internal Hemorrhoids, run by Universitätsklinikum Hamburg-Eppendorf.
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 5 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postoperative Pain (time frame: within the first 30 days after surgery). 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 NCT01533363, 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 15 Feb 2012.