Symptomatic Haemorrhoidal DiseaseNCT01038141
Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease
A study testing Surgery for advanced haemorrhoidal disease in people with Symptomatic Haemorrhoidal Disease, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Haemorrhoidal Disease
- What is being tested?
- Surgery for advanced haemorrhoidal disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- Patients with symptomatic grade 3 and 4 haemorrhoidal disease
- Age 18-80
- Patients who are fitted for local and general anaesthesia
- Patients who are able to understand the information given and are willing to give a written consent
Who cannot join
- Previous operated for piles
- Previous operated in the anal canal
- Faecal incontinence
- Inflammatory bowel disease with affection of the anal canal
- Chronic diarrhea
- Fissura ani
Show all 16Show fewer
- Fistula in ano
- Chronic anal pain
- Neurological illness with affection of anal sensation
- Patients not able to follow the study protocol
- Patients taking immunosuppressant medication
- Pregnancy
- Disability
- Anal polyps
- Medication affecting the coagulation system
- Circular anal prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease. A Prospective Randomized Controlled Study
The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.
Read the detailed description
An estimated 4% of the adult population suffers from haemorrhoidal disease. In 1937 E. T. Milligan and C. N. Morgan described a method for operating piles that still is regarded "the gold standard" in the treatment of severe haemorrhoidal disease. This procedure is followed by a prolonged and painful recovery. To overcome the long recovery often combined with long sick leaves, less invasive methods for treating piles have been introduced during the last decade. However, few studies have compared patient benefits and the long term outcome of these techniques, and the choice of treatment is often based on the skills and experience of the individual surgeon. A new and promising mini invasive approach utilizes doppler-guided ligation of the haemorrhoidal arteries. All haemorrhoidal arteries are identified and then ligated approximately 2 cm above the anal canal. Thereafter the rectal mucosa with the piles is repositioned and fixed in the rectum with running sutures. This procedure is termed Recto Anal Repair (RAR) and leads to shrinking of the piles and restored anatomy of the anus and the rectum. The investigators want to execute a randomized, consecutive, prospective, controlled study with long term follow up to compare the RAR procedure to Milligans operation for the treatment of severe haemorrhoidal disease.
The primary goals are evaluation of pain and sick leave 7, 14 and 21 days after surgery and reported reduction of pile symptoms after 3, 6 and 12 months. In addition the investigators want to compare the overall satisfaction with the two procedures.
- Conditions
- Symptomatic Haemorrhoidal Disease
- Being tested
- Surgery for advanced haemorrhoidal disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for advanced haemorrhoidal diseaseProcedure or surgery
Also called Transanal doppler-guided hemorrhoidal artery ligation., Transanal hemorrhoidal dearterialization (THD).
Milligan Morgan vs Recto Anal Repair
| Study group | Role | What they receive |
|---|---|---|
| Milligan Morgan | Active comparator | Not described Receives: Procedure: Surgery for advanced haemorrhoidal disease |
| Recto Anal Repair | Active comparator | Not described Receives: Procedure: Surgery for advanced haemorrhoidal disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain
Measured: up to 21 days
Secondary outcomes (1)
Evaluation of sick leave
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2013
Why it stopped: Due to lack of time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Haemorrhoidal DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Investigators
- Geir A Larsen, M.D., Ph.D., Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038141
- Sponsor's protocol ID
- 583-07315a 1.2007.2484(REK)
- Status last verified
- Jun 2014
- First submitted
- 22 Dec 2009
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease. A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01038141
- Acronym / sponsor ID
- 583-07315a 1.2007.2484(REK)
- Conditions
- Symptomatic Haemorrhoidal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of time.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2013 (actual)
- First posted
- 23 Dec 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.
The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.
Detailed description
An estimated 4% of the adult population suffers from haemorrhoidal disease. In 1937 E. T. Milligan and C. N. Morgan described a method for operating piles that still is regarded "the gold standard" in the treatment of severe haemorrhoidal disease. This procedure is followed by a prolonged and painful recovery. To overcome the long recovery often combined with long sick leaves, less invasive methods for treating piles have been introduced during the last decade. However, few studies have compared patient benefits and the long term outcome of these techniques, and the choice of treatment is often based on the skills and experience of the individual surgeon. A new and promising mini invasive approach utilizes doppler-guided ligation of the haemorrhoidal arteries. All haemorrhoidal arteries are identified and then ligated approximately 2 cm above the anal canal. Thereafter the rectal mucosa with the piles is repositioned and fixed in the rectum with running sutures. This procedure is termed Recto Anal Repair (RAR) and leads to shrinking of the piles and restored anatomy of the anus and the rectum. The investigators want to execute a randomized, consecutive, prospective, controlled study with long term follow up to compare the RAR procedure to Milligans operation for the treatment of severe haemorrhoidal disease.
The primary goals are evaluation of pain and sick leave 7, 14 and 21 days after surgery and reported reduction of pile symptoms after 3, 6 and 12 months. In addition the investigators want to compare the overall satisfaction with the two procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milligan Morgan | Active comparator | Procedure: Surgery for advanced haemorrhoidal disease |
| Recto Anal Repair | Active comparator | Procedure: Surgery for advanced haemorrhoidal disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with symptomatic grade 3 and 4 haemorrhoidal disease
- Age 18-80
- Patients who are fitted for local and general anaesthesia
- Patients who are able to understand the information given and are willing to give a written consent
Key exclusion criteria (16 listed)
- Previous operated for piles
- Previous operated in the anal canal
- Faecal incontinence
- Inflammatory bowel disease with affection of the anal canal
- Chronic diarrhea
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 |
|---|---|---|
| Surgery for advanced haemorrhoidal diseaseAlso: Transanal doppler-guided hemorrhoidal artery ligation., Transanal hemorrhoidal dearterialization (THD).Milligan Morgan vs Recto Anal Repair | Procedure or surgery | Milligan Morgan, Recto Anal Repair |
Primary outcome
Evaluation of pain
Time frame: up to 21 days
1 secondary outcome
Evaluation of sick leave
Time frame: up to 21 days
Results and safety
The study was stopped early (reason given: Due to lack of time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Related trials for Symptomatic Haemorrhoidal Disease
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
RecruitingObservational study
Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty
Haemorrhoid, Haemorrhoidal Bleeding
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.
Geir A Larsen, M.D., Ph.D. principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for advanced haemorrhoidal disease in people with Symptomatic Haemorrhoidal Disease, run by University Hospital, Akershus at 1 site in Norway.
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 16 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: stopped early, as of the sponsor's last update on 30 Jul 2014. 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 Norway. 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 was stopped early (reason given: Due to lack of time.). Results are not available in the source record.
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?
Evaluation of pain (time frame: up to 21 days). 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 30 Jul 2014.