A case control comparative study comparing the benefit of adding local and short term antibiotics to local analgesic and vasodilators in patients of anal fissures
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Recovery rate
研究概览
简要总结
Anal fissure is one of the most common presenting complaints in the outpatient departments of general surgery. It is a well-recognized cause of acute anal pain. Although the exact pathophysiology is not yet elucidated but subclinical infection is hypothesized to be associated with chronic anal fissure. In previous studies addition of both oral and local antibiotics to conservative management benefited the patients with both acute and chronic anal fissure.
Hypothesis: addition of local antibiotic to conservative management may hasten and improve recovery rate
Local vasodilator and analgesic or anaesthetic have proven benefits in both acute and chronic anal fissure. To evaluate whether addition of local antibiotic has any added advantage in terms of recovery and patient’s satisfaction this present study is undertaken.
Patients of acute anal fissure were recruited after obtaining informed consent. Randomized as per allocation sequence done. 68 patients are recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with clinical diagnosis of anal fissure
- •lesions limited to the epithelium,
- •patients who has pain in the anal region together with ulcers
- •Ulcer in the posterior anoderm without any skin tags
- •Consenting patients willing to voluntarily take part in this study after getting detailed information.
排除标准
- •Presumed or confirmed pregnancy
- •Lactating women
- •History of reaction or intolerance to topical agents
- •Associated co-morbidity, such as ischemic heart disease, hypertension,chronic obstructive pulmonary disease, diabetes mellitus, inflammatory bowel disease, HIV- related fissure, tuberculosis ulcer and leukemic ulcer; and associated complications warranting surgery (abscess, fistula, haemorrhoids, and cancer).
结局指标
主要结局
Recovery rate
时间窗: 3rd week and 6th week of treatment
次要结局
- VAS score(1st week, 3rd week and 6th week of starting treatment)