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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
Both arms are standard care procedures in the Netherlands
Both arms are standard care procedures in the Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
RECRUITINGMeander MC
Amersfoort, Netherlands
RECRUITINGOLVG
Amsterdam, Netherlands
RECRUITINGUniversity Medical Center location AMC
Amsterdam, Netherlands
RECRUITINGIJsselland ziekenhuis
Capelle aan den IJssel, Netherlands
RECRUITINGGroene Hart ziekenhuis
Gouda, Netherlands
RECRUITINGMUMC+
Maastricht, Netherlands
RECRUITINGCentraal Militair Hospitaal
Utrecht, Netherlands
RECRUITINGDiakonessenhuis
Utrecht, Netherlands
RECRUITINGHealth 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: this will be asked at 6 weeks, 6, 12 and 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 12 months
Patient reported outcome measures concerning symptoms in daily life; HHS
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Hemorrhoid severity score consists of five questions concerning the frequency of symptoms of hemorrhoids. The higher the score the more frequent the symptoms occur.
Time frame: 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'.
Time frame: 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
Time frame: this will be asked at 1 week and 6 weeks post procedure.
Need for further treatment
Time frame: 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
Time frame: 12 months