Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Change in CORRECTS scale
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in the therapy of symptomatic hemorrhoids. Efficacy will be determined by:
- the change from baseline in pain, itching, bleeding, swelling, discomfort, general well-being and improvement since the beginning of treatment as separate components of CORRECTS scale
- the change in overall CORRECTS values from baseline
- the change in degree of hemorrhoids from baseline
详细描述
This is a double blinded randomized clinical study into the effect of topical 2% lidocaine in patients with symptomatic hemorrhoids.
Calculated sample size is 69 patients per arm, based on expected improvement of pain and healing by 30% at p<0.05 and power goal of 95%. Taking into account a drop-out rate of 50%, total number of 69 patients in each arm is estimated as sufficient to close the study.
Patients will be randomly assigned into 2 arms, arm 1 (treatment): topical 2% lidocaine and arm 2 (control): vaseline base. Each arm will consist of 69 patients. Patients will be assigned to either treatment or control arm according to the randomization table.
- Treatment arm - topical 2% lidocaine. Topical application of 2% lidocaine in vaseline base repeated two times per day,
- Control arm - vaseline base. Topical application of pure vaseline base twice per day.
In addition to the aforementioned topical treatments, all patients will be given written instructions to perform dietary modifications and anal hygiene. All patients with bleeding hemorrhoids will be given Detralex 2 tablets twice per day.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •clinically present enlarged hemorrhoids, grade 1-4 (for definition see Appendix 1)
- •symptoms of pain or itching
- •age 18 years or more
- •willing and able to comply with the study
- •geographically suitable, meaning with reliable transportation for outpatients to the testing site
排除标准
- •actual pregnancy
- •inability to provide informed consent
- •any anal topical medication applied in the last 7 days
- •any anal surgery (including surgical or instrumental procedures defined in the section 4.3) in the last 60 days
- •known allergy to vaseline, lidocaine or Dulcolax
- •other anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections
- •contraindication for topical anal application of vaseline or lidocaine
研究组 & 干预措施
2% lidocaine
topical application, two times per day for 15 consecutive days
干预措施: 2% lidocaine (Drug)
placebo
vaseline base applied topically, two times per day for 15 consecutive days
干预措施: placebo (Drug)
结局指标
主要结局
Change in CORRECTS scale
时间窗: 15 days after treatment initiantion
Change in CORRECTS scale and grade of haemorrhoids
次要结局
- Percentage of adverse events(within 15 days after treatment initiation)
研究者
Mario Kopljar
Dr. sc.
University Hospital Dubrava