HemorrhoidsHollANDNCT04621695
Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III
A study testing RBL and Hemorrhoidectomy in people with Hemorrhoids and Hemorrhoids, Internal, run by Proctos Kliniek at 9 sites in Netherlands.
Trial summary
Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. Given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Hemorrhoids, Internal, PROM
- What is being tested?
- RBL and Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 9 sitesNetherlands
- Study dates
- 25 Nov 2019to 25 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemorrhoids grade III (Goligher classification)
- Age 18 years and older
- Sufficient understanding of the Dutch written language (reading and writing)
Who cannot join
- Previous rectal or anal surgery with the exception of rubber band ligation
- Previous surgery for haemorrhoids (at any time)
- More than one injection treatment for haemorrhoids in the past 3 years
- More than one rubber band ligation procedure in the past 3 years
- Previous rectal radiation
- Pre-existing sphincter injury
Show all 12Show fewer
- Inflammatory bowel disease
- Medically unfit for surgery or for completion of the trial (ASA>III)
- Pregnancy
- Hyper-coagulability disorders
- Patients previously randomised to this trial
- Not able or willing to provide written informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites, 9 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad
Schouten, dr.
- Recruiting
Meander MC
Amersfoort
Verheijen, dr.
- Recruiting
OLVG
Amsterdam
de Castro, dr.
- Recruiting
University Medical Center location AMC
Amsterdam
Bemelman, prof. dr.
- Recruiting
IJsselland ziekenhuis
Capelle aan den IJssel
van Ruler, dr.
- Recruiting
Groene Hart ziekenhuis
Gouda
Baeten, dr.
- Recruiting
MUMC+
Maastricht
Breukink, dr.
- Recruiting
Centraal Militair Hospitaal
Utrecht
Meij, dr.
- Recruiting
Diakonessenhuis
Utrecht
Schiphorst, dr.
About this study
Official title: Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III: a Multicentre, Randomized Controlled Trial and Cost-utility Analysis.
Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. Given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. An interesting conclusion from a recent systematic review regarding operative procedures for haemorrhoidal disease is that all procedures have their own advantages and disadvantages. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. So far there is no sufficiently large trial that meets that demand.
Objective: To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. The assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life.
Read more
Study design:Multicentre randomized controlled non-inferiority trial with cost-utility analysis. Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation.
Study population: Patients aged ≥ 18 years with symptomatic haemorrhoids gr III. Patients are recruited in multiple clinics during 18-24 months.
Intervention: Participants are allocated to either rubber band ligation or haemorrhoidectomy.
Main study parameters/endpoints: Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. Secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (HSS, PROM, PROMHISS), vaizey score, resumption of work, pain (VAS), complications and recurrence at two years.
- Conditions
- Hemorrhoids, Hemorrhoids, Internal, PROM, Rectal Diseases
- Being tested
- RBL, Hemorrhoidectomy
- Keywords
- Hemorrhoids, Hemorrhoidal disease, Rubber band ligation, Hemorrhoidectomy, PROM
- Medical subject headings
- Hemorrhoids, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBLProcedure or surgery
Both arms are standard care procedures in the Netherlands
HemorrhoidectomyProcedure or surgery
Both arms are standard care procedures in the Netherlands
| Study group | Role | What they receive |
|---|---|---|
| Rubber band ligation | Other | Rubber band ligation is performed by a suction device that allows a rubber band to be applied at the base of the haemorrhoid via a proctoscope. Maximal suction force used is 40 mmHg. A maximum of 3-4 bands are used per session. This rubber band constricts the blood supply causing it to become ischaemic before being sloughed approximately 1-2 weeks later. The resultant fibrosis reduces any element of haemorrhoidal prolapse that may have been present. No sedation is required for this day-care procedure. Patients are asked to administer an enema 2 hours prior to the procedure. Receives: Procedure: RBL |
| Hemorrhoidectomy | Other | There are two main excisional procedures currently carried out: open (Milligan and Morgan) and closed (Ferguson). Both have the intention of excising the haemorrhoidal cushions. The procedure is performed under either general or spinal anaesthesia in a day-care setting.
Patients were asked to administer an enema 2 hours prior to the procedure. Receives: Procedure: Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient's HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient's health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient's self-rated health with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom.
Measured: 24 months
Recurrence
Patient self reported assessment with a dichotomous question: "At the moment, do you feel your symptoms from your haemorrhoids are: (1) cured or improved compared with before treatment; or (2) unchanged or worse compared with before treatment?" Any patient who answers '1' but has required further treatment since the initial procedure will be reclassified as '2', identified via hospital records, their consultant and patient questioning
Measured: at 12 months
In-hospital direct costs
with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
Measured: this will be asked at 6 weeks, 6, 12 and 24 months
In-hospital indirect costs
with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
Measured: this will be asked at 6 weeks, 6, 12 and 24 months
Out-of-hospital postoperative costs
with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
Measured: this will be asked at 6 weeks, 6, 12 and 24 months
Secondary outcomes (9)
Health related quality of life
The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient's HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient's health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient's self-rated health with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom.
Measured: 12 months
Patient reported outcome measures concerning symptoms in daily life; Vaizey score
Vaizey faecal continence score consists of 7 questions with a maximum of score of 24. The higher the score, the higher the worse the outcome.
Measured: 12 months
Patient reported outcome measures concerning symptoms in daily life; proctoPROM
The proctoPROM is a validated questionnaire consisting of five questions concerning patients well-being, wich are each scored on a numeric rating scale from 0 to 10. Regarding impact of symptoms, 0 correlates with 'no impact at all' and 10 with 'highly impacted on daily life'. Than the mean of the 5 question is taken.
Measured: 12 months
Patient reported outcome measures concerning symptoms in daily life; PROM-HISS
Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score which are each scored on a numeric rating scale from 0 to 10. Regarding impact of symptoms, 0 correlates with 'no impact at all' and 10 with 'highly impacted on daily life'. For patient satisfaction with treatment, this ranges between 0 'not satisfied' and 10 'very satisfied'.
Measured: 12 months
Patient reported outcome measures concerning symptoms in daily life; HHS
Hemorrhoid severity score consists of five questions concerning the frequency of symptoms of hemorrhoids. The higher the score the more frequent the symptoms occur.
Measured: 12 months
Patient reported outcome measures concerning symptoms in daily life, VAS pain score
The pain visual analogue scale has a numeric rating scale from 0 to 10 with 0 being 'no pain' and 10 'worse pain you ever felt'.
Measured: this will be asked 1 day post procedure, 1 week and 6 weeks post procedure.
Return to work
Number of days patients are able to return to work
Measured: this will be asked at 1 week and 6 weeks post procedure.
Need for further treatment
Measured: 12 months
Complications
Adverse events as: peroperative bleeding, postoperative bleeding, urinary retention requiring catheterisation, pelvic sepsis, anal fissure, anal fistula, wound discharge, residual anal skintages, anal stenosis, fecal incontinence, death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start25 Nov 2019
- Primary completion25 Nov 2023 (estimated)
- Study completion25 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proctos Kliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. IJM Han-Geurts, Proctos Kliniek
- Investigators
- Ingrid Han-Geurts, MD PhD, Principal investigator, Proctos KliniekWillem Bemelman, Prof., Study chair, Amsterdam University Medical Center, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621695
- Sponsor's protocol ID
- NL69227.018.19
- Acronym
- HollAND
- Status last verified
- Mar 2021
- First submitted
- 23 Oct 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: (Several versions of) processed data, documentation of the research process, including deindentified participant data, raw data, syntaxes
Publications
van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HOLLAND study group. Cost-Effectiveness of Rubber Band Ligation Versus Hemorrhoidectomy for the Treatment of Grade III Hemorrhoids: Analysis Using Evidence From the HOLLAND Randomized Controlled Trial. Dis Colon Rectum. 2025 Sep 1;68(9):1100-1111. doi: 10.1097/DCR.0000000000003832. Epub 2025 Jun 10.
PubMed 40492557van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HollAND Study Group. Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial. Dis Colon Rectum. 2025 May 1;68(5):572-583. doi: 10.1097/DCR.0000000000003679. Epub 2025 Feb 14.
PubMed 39952268
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III: a Multicentre, Randomized Controlled Trial and Cost-utility Analysis.
- ClinicalTrials.gov ID
- NCT04621695
- Acronym / sponsor ID
- HollAND / NL69227.018.19
- Conditions
- Hemorrhoids, Hemorrhoids, Internal, PROM, Rectal Diseases
- Keywords
- Hemorrhoids, Hemorrhoidal disease, Rubber band ligation, Hemorrhoidectomy, PROM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Proctos KliniekUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 25 Nov 2023 (estimated)
- First posted
- 9 Nov 2020 (actual)
- 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.
Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. Given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. An interesting conclusion from a recent systematic review regarding operative procedures for haemorrhoidal disease is that all procedures have their own advantages and disadvantages. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. So far there is no sufficiently large trial that meets that demand.
Objective: To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. The assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life.
Study design:Multicentre randomized controlled non-inferiority trial with cost-utility analysis. Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation.
Study population: Patients aged ≥ 18 years with symptomatic haemorrhoids gr III. Patients are recruited in multiple clinics during 18-24 months.
Intervention: Participants are allocated to either rubber band ligation or haemorrhoidectomy.
Main study parameters/endpoints: Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. Secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (HSS, PROM, PROMHISS), vaizey score, resumption of work, pain (VAS), complications and recurrence at two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rubber band ligation | Other | Procedure: RBLRubber band ligation is performed by a suction device that allows a rubber band to be applied at the base of the haemorrhoid via a proctoscope. Maximal suction force used is 40 mmHg. A maximum of 3-4 bands are used per session. This rubber band constricts the blood supply causing it to become ischaemic before being sloughed approximately 1-2 weeks later. The resultant fibrosis reduces any element of haemorrhoidal prolapse that may have been present. No sedation is required for this day-care procedure. Patients are asked to administer an enema 2 hours prior to the procedure. |
| Hemorrhoidectomy | Other | Procedure: HemorrhoidectomyThere are two main excisional procedures currently carried out: open (Milligan and Morgan) and closed (Ferguson). Both have the intention of excising the haemorrhoidal cushions. The procedure is performed under either general or spinal anaesthesia in a day-care setting. Patients were asked to administer an enema 2 hours prior to the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Haemorrhoids grade III (Goligher classification)
- Age 18 years and older
- Sufficient understanding of the Dutch written language (reading and writing)
Key exclusion criteria (12 listed)
- Previous rectal or anal surgery with the exception of rubber band ligation
- Previous surgery for haemorrhoids (at any time)
- More than one injection treatment for haemorrhoids in the past 3 years
- More than one rubber band ligation procedure in the past 3 years
- Previous rectal radiation
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 |
|---|---|---|
| RBLBoth arms are standard care procedures in the Netherlands | Procedure or surgery | Rubber band ligation |
| HemorrhoidectomyBoth arms are standard care procedures in the Netherlands | Procedure or surgery | Hemorrhoidectomy |
Primary outcome
Health related quality of life
Time frame: 24 months
The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient's HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient's health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient's self-rated health with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom.
Recurrence
Time frame: at 12 months
Patient self reported assessment with a dichotomous question: "At the moment, do you feel your symptoms from your haemorrhoids are: (1) cured or improved compared with before treatment; or (2) unchanged or worse compared with before treatment?" Any patient who answers '1' but has required further treatment since the initial procedure will be reclassified as '2', identified via hospital records, their consultant and patient questioning
In-hospital direct costs
Time frame: this will be asked at 6 weeks, 6, 12 and 24 months
with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
In-hospital indirect costs
Time frame: this will be asked at 6 weeks, 6, 12 and 24 months
with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
Out-of-hospital postoperative costs
Time frame: this will be asked at 6 weeks, 6, 12 and 24 months
with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
9 secondary outcomes
Health related quality of life
Time frame: 12 months
Patient reported outcome measures concerning symptoms in daily life; Vaizey score
Time frame: 12 months
Patient reported outcome measures concerning symptoms in daily life; proctoPROM
Time frame: 12 months
Patient reported outcome measures concerning symptoms in daily life; PROM-HISS
Time frame: 12 months
Patient reported outcome measures concerning symptoms in daily life; HHS
Time frame: 12 months
Patient reported outcome measures concerning symptoms in daily life, VAS pain score
Time frame: this will be asked 1 day post procedure, 1 week and 6 weeks post procedure.
Return to work
Time frame: this will be asked at 1 week and 6 weeks post procedure.
Need for further treatment
Time frame: 12 months
Complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Derived from this study: PubMed 40492557van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HOLLAND study group. Cost-Effectiveness of Rubber Band Ligation Versus Hemorrhoidectomy for the Treatment of Grade III Hemorrhoids: Analysis Using Evidence From the HOLLAND Randomized Controlled Trial. Dis Colon Rectum. 2025 Sep 1;68(9):1100-1111. doi: 10.1097/DCR.0000000000003832. Epub 2025 Jun 10.
- Derived from this study: PubMed 39952268van Oostendorp JY, Dekker L, van Dieren S, Veldkamp R, Bemelman WA, Han-Geurts IJM; HollAND Study Group. Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial. Dis Colon Rectum. 2025 May 1;68(5):572-583. doi: 10.1097/DCR.0000000000003679. Epub 2025 Feb 14.
- Study websiteLink provided by the sponsor.
- Dutch Workgroup ColoproctologyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. (Several versions of) processed data, documentation of the research process, including deindentified participant data, raw data, syntaxes
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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.
Ingrid Han-Geurts, MD PhD principal investigator
Proctos Kliniek
Willem Bemelman, Prof. study chair
Amsterdam University Medical Center, location AMC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBL and Hemorrhoidectomy in people with Hemorrhoids and Hemorrhoids, Internal, run by Proctos Kliniek at 9 sites in Netherlands.
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 12 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. 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?
Contact Lisette Dekker, MD (+31612204316, l.dekker@proctoskliniek.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: 24 months). The study lists 5 primary outcomes in all. 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 NCT04621695, which also lists 2 linked publications.
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 16 Mar 2021.