Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III: a Multicentre, Randomized Controlled Trial and Cost-utility Analysis.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 9
- 主要终点
- Health related quality of life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemorrhoids grade III (Goligher classification)
- •Age 18 years and older
- •Sufficient understanding of the Dutch written language (reading and writing)
排除标准
- •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
结局指标
主要结局
Health related quality of life
时间窗: 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
时间窗: 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 indirect costs
时间窗: 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
时间窗: 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 direct costs
时间窗: 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.
次要结局
- Health related quality of life(12 months)
- Patient reported outcome measures concerning symptoms in daily life; proctoPROM(12 months)
- Patient reported outcome measures concerning symptoms in daily life; Vaizey score(12 months)
- Complications(12 months)
- Patient reported outcome measures concerning symptoms in daily life, VAS pain score(this will be asked 1 day post procedure, 1 week and 6 weeks post procedure.)
- 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)
- Return to work(this will be asked at 1 week and 6 weeks post procedure.)
- Need for further treatment(12 months)
研究者
dr. IJM Han-Geurts
Principal investigator
Proctos Kliniek