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

Hemorrhoids Clinical Trial

— HollAND  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04621695
• Other study ID #: NL69227.018.19
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: November 25, 2023

Study information

• Verified date: March 2021
• Source: Proctos Kliniek
• Contact: Lisette Dekker, MD
• Phone: +31612204316
• Email: l.dekker[@]proctoskliniek.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Haemorrhoids grade III (Goligher classification)

• Age 18 years and older

• Sufficient understanding of the Dutch written language (reading and writing)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hemorrhoids
• Hemorrhoids, Internal
• PROM
• Rectal Diseases

Intervention

Procedure:
• RBL
Both arms are standard care procedures in the Netherlands
• Hemorrhoidectomy
Both arms are standard care procedures in the Netherlands

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere
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

Sponsors (1)

Lead Sponsor	Collaborator
Proctos Kliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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'.	12 months
Secondary	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.	12 months
Secondary	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'.	this will be asked 1 day post procedure, 1 week and 6 weeks post procedure.
Secondary	Return to work	Number of days patients are able to return to work	this will be asked at 1 week and 6 weeks post procedure.
Secondary	Need for further treatment		12 months
Secondary	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	12 months

External Links

•   Dutch Workgroup Coloproctology
•   Study website