Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III
NCT ID: NCT04621695
Last Updated: 2021-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2019-11-25
2023-11-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rubber band ligation
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.
RBL
Both arms are standard care procedures in the Netherlands
Hemorrhoidectomy
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.
Hemorrhoidectomy
Both arms are standard care procedures in the Netherlands
Interventions
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RBL
Both arms are standard care procedures in the Netherlands
Hemorrhoidectomy
Both arms are standard care procedures in the Netherlands
Eligibility Criteria
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Inclusion Criteria
* Age 18 years and older
* Sufficient understanding of the Dutch written language (reading and writing)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Proctos Kliniek
OTHER
Responsible Party
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dr. IJM Han-Geurts
Principal investigator
Principal Investigators
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Ingrid Han-Geurts, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Proctos Kliniek
Willem Bemelman, Prof.
Role: STUDY_CHAIR
Amsterdam University Medical Center, location AMC
Locations
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Flevoziekenhuis
Almere Stad, , Netherlands
Meander MC
Amersfoort, , Netherlands
OLVG
Amsterdam, , Netherlands
University Medical Center location AMC
Amsterdam, , Netherlands
IJsselland ziekenhuis
Capelle aan den IJssel, , Netherlands
Groene Hart ziekenhuis
Gouda, , Netherlands
MUMC+
Maastricht, , Netherlands
Centraal Militair Hospitaal
Utrecht, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Schouten, dr.
Role: primary
Verheijen, dr.
Role: primary
de Castro, dr.
Role: primary
Bemelman, prof. dr.
Role: primary
van Ruler, dr.
Role: primary
Baeten, dr.
Role: primary
Breukink, dr.
Role: primary
Meij, dr.
Role: primary
Schiphorst, dr.
Role: primary
References
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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.
van 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.
Related Links
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Study website
Other Identifiers
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NL69227.018.19
Identifier Type: -
Identifier Source: org_study_id
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