Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III

NCT04621695 | Unknown DMC

• 1 other identifier: NL69227.018.19
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Hemorrhoids; Hemorrhoids, Internal; PROM; Rectal Diseases

Keywords

Hemorrhoids; Hemorrhoidal disease; Rubber band ligation; Hemorrhoidectomy; PROM

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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.

  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.

  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.

  this will be asked at 6 weeks, 6, 12 and 24 months

Secondary Outcomes (9)

• Health related quality of life

  12 months

• Patient reported outcome measures concerning symptoms in daily life; Vaizey score

  12 months

• Patient reported outcome measures concerning symptoms in daily life; proctoPROM

  12 months

• Patient reported outcome measures concerning symptoms in daily life; PROM-HISS

  12 months

• Patient reported outcome measures concerning symptoms in daily life; HHS

  12 months

Study Arms (2)

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.

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.

Procedure: Hemorrhoidectomy

Interventions

RBL PROCEDURE

Both arms are standard care procedures in the Netherlands

Rubber band ligation

Hemorrhoidectomy PROCEDURE

Both arms are standard care procedures in the Netherlands

Hemorrhoidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Haemorrhoids grade III (Goligher classification)
• Age 18 years and older
• Sufficient understanding of the Dutch written language (reading and writing)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Proctos Kliniek: lead

Study Sites (9)

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Meander MC

Amersfoort, Netherlands

RECRUITING

OLVG

Amsterdam, Netherlands

RECRUITING

University Medical Center location AMC

Amsterdam, Netherlands

RECRUITING

IJsselland ziekenhuis

Capelle aan den IJssel, Netherlands

RECRUITING

Groene Hart ziekenhuis

Gouda, Netherlands

RECRUITING

MUMC+

Maastricht, Netherlands

RECRUITING

Centraal Militair Hospitaal

Utrecht, Netherlands

RECRUITING

Diakonessenhuis

Utrecht, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 40492557 DERIVED

• 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.

  PMID: 39952268 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Hemorrhoids; Rectal Diseases

Interventions

Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ingrid Han-Geurts, MD PhD

  Proctos Kliniek

  PRINCIPAL INVESTIGATOR

• Willem Bemelman, Prof.

  Amsterdam University Medical Center, location AMC

  STUDY CHAIR

Central Study Contacts

Lisette Dekker, MD

CONTACT

+31612204316; l.dekker@proctoskliniek.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 9, 2020
• Study Start: November 25, 2019
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months embargo due to publishing.
• Access Criteria: There will be access restrictions to my data collection. A request must be made at Data Access Committee (DAC).

Locations

NL (9)