HemorrhoidsNCT02061176
THD Versus Open Haemorrhoidectomy
A study testing Transanal Haemorrhoidal Dearterialization and Open Haemorrhoidectomy in people with Hemorrhoids, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Transanal Haemorrhoidal Dearterialization and Open Haemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Dec 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
- The patient has a Haemorrhoidal Symptom Score of 4 or more
- The patient has an American Society of Anaesthesiologists (ASA) score I-II
- The patient's age is 18-85 years at inclusion
- The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion
Who cannot join
- The patient has had previous operation for haemorrhoids within the last 2 years
- The patient has had previous operation for anal incontinence
- The patient has an active anal fistula
- The patient has an active anal fissure
- The patient has anal incontinence for solid stools
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.
Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.
- Conditions
- Hemorrhoids
- Being tested
- Transanal Haemorrhoidal Dearterialization, Open Haemorrhoidectomy
- Keywords
- Hemorrhoids, Haemorrhoids, Transanal Haemorrhoidal Dearterialization, Transanal Hemorrhoidal Dearterialisation, Open Haemorrhoidectomy, Open Hemorrhoidectomy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal Haemorrhoidal DearterializationProcedure or surgery
Also called Hemorrhoidal Artery Ligation
Open HaemorrhoidectomyProcedure or surgery
Also called Milligan Morgan, Haemorrhoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Transanal Haemorrhoidal Dearterialization | Experimental | Patients randomised to Transanal Haemorrhoidal Dearterialization. Receives: Procedure: Transanal Haemorrhoidal Dearterialization |
| Open Haemorrhoidectomy | Active comparator | Patients randomised to Open Haemorrhoidectomy Receives: Procedure: Open Haemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemorrhoidal Symptoms
Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20.
The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively.
Measured: 1-year and 5-years postoperatively
Secondary outcomes (5)
Postoperative pain
Postoperative pain is registered using visual analog scale (VAS), by the hospital staff in the immediate postoperative course during hospital stay and by the patient the first 14 days postoperatively.
Measured: 14 days postoperatively
Complications
Early and late complications are registered at 3 and 12 months and 5 years follow up.
Measured: 1-year and 5-years postoperatively
Anal continence
Effect on anal continence is evaluated by Wexner Anal Incontinence Score and Revised Faecal Incotinence Score (RFIS) preoperatively, 3- and 12 months and 5 years postoperatively.
Measured: 1-year and 5-years postoperatively
Quality of Life
QoL is evaluated using Short Health Scale, Short Form(SF)-36 and EQ-5D preoperatively, 1-year and 5-years postoperatively.
Measured: 1-year and 5-years postoperatively
Health cost analysis
Health cost analysis will be based on an estimate of the cost of the operations, recovery of the patients and effect (need for further procedures or medical care).
Measured: 1-year and 5-years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
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 HemorrhoidsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Olov Gunnar Olaison, Holbaek Sygehus
- Investigators
- Gunnar Olaison, MD, Ph.D, Principal investigator, Departement of Surgery, Holbaek County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061176
- Sponsor's protocol ID
- Holbaek Haemorrhoid Study
- Status last verified
- Dec 2017
- First submitted
- 11 Feb 2014
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rorvik HD, Campos AH, Styr K, Ilum L, McKinstry GK, Brandstrup B, Olaison G. Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial. Dis Colon Rectum. 2020 May;63(5):655-667. doi: 10.1097/DCR.0000000000001588.
PubMed 31996581
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Haemorrhoidal Dearterialization (THD) Versus Open Haemorrhoidectomy for the Treatment of Haemorrhoids. An Open Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02061176
- Acronym / sponsor ID
- Holbaek Haemorrhoid Study
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids, Haemorrhoids, Transanal Haemorrhoidal Dearterialization, Transanal Hemorrhoidal Dearterialisation, Open Haemorrhoidectomy, Open Hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Feb 2014 (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.
A randomised study comparing Transanal Haemorrhoidal Dearterialization (THD) and Open Haemorrhoidectomy (OH) for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate the long-term effect on haemorrhoidal symptoms one year postoperatively.
Secondary endpoints are postoperative pain, complications, effect on anal continence, recovery and return to normal activity, quality of life and health cost analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal Haemorrhoidal Dearterialization | Experimental | Procedure: Transanal Haemorrhoidal DearterializationPatients randomised to Transanal Haemorrhoidal Dearterialization. |
| Open Haemorrhoidectomy | Active comparator | Procedure: Open HaemorrhoidectomyPatients randomised to Open Haemorrhoidectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient has Grade III-IV haemorrhoids or Grade II haemorrhoids with bleeding resistant to rubber band ligation or sclerotherapy
- The patient has a Haemorrhoidal Symptom Score of 4 or more
- The patient has an American Society of Anaesthesiologists (ASA) score I-II
- The patient's age is 18-85 years at inclusion
- The patient has had a colonoscopy, sigmoidoscopy or rigid rectoscopy within 3 months before inclusion
Key exclusion criteria (5 listed)
- The patient has had previous operation for haemorrhoids within the last 2 years
- The patient has had previous operation for anal incontinence
- The patient has an active anal fistula
- The patient has an active anal fissure
- The patient has anal incontinence for solid stools
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 |
|---|---|---|
| Transanal Haemorrhoidal DearterializationAlso: Hemorrhoidal Artery Ligation | Procedure or surgery | Transanal Haemorrhoidal Dearterialization |
| Open HaemorrhoidectomyAlso: Milligan Morgan, Haemorrhoidectomy | Procedure or surgery | Open Haemorrhoidectomy |
Primary outcome
Haemorrhoidal Symptoms
Time frame: 1-year and 5-years postoperatively
Five questions regarding haemorrhoidal symptoms (pain, bleeding, itching, soiling and prolapse) are used to grade the symptom load. Each symptom is graded from 0-4, giving a total score from 0-20. The symptom score is registered preoperatively, 3 and 12 months and 5 years postoperatively.
5 secondary outcomes
Postoperative pain
Time frame: 14 days postoperatively
Complications
Time frame: 1-year and 5-years postoperatively
Anal continence
Time frame: 1-year and 5-years postoperatively
Quality of Life
Time frame: 1-year and 5-years postoperatively
Health cost analysis
Time frame: 1-year and 5-years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Derived from this study: PubMed 31996581Rorvik HD, Campos AH, Styr K, Ilum L, McKinstry GK, Brandstrup B, Olaison G. Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial. Dis Colon Rectum. 2020 May;63(5):655-667. doi: 10.1097/DCR.0000000000001588.
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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.
Gunnar Olaison, MD, Ph.D principal investigator
Departement of Surgery, Holbaek County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal Haemorrhoidal Dearterialization and Open Haemorrhoidectomy in people with Hemorrhoids, run by Holbaek Sygehus 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 5 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: status not confirmed, as of the sponsor's last update on 4 Dec 2017. 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.
Are results available for this study?
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?
Haemorrhoidal Symptoms (time frame: 1-year and 5-years postoperatively). 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 NCT02061176, 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 4 Dec 2017.