Effect of Additional Topical Diltiazem on Botulinum Toxin Injection for Chronic Anal Fissure: Retrospective Analysis of 217 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Fissure healing at 1 month
研究概览
简要总结
Anal fissure (AF) is a painful tear extending from the anal canal to the dentate line. Although the exact pathophysiology is not known, an increase in anal tonus, decreased ano-dermal blood flow and local ischemia are possible mechanisms. The most effective treatment modality in chronic AF is lateral internal sphincterotomy however, incontinence rates are still reported as high as 8-30%. Topical diltiazem and botulinum toxin (BT) injection are good alternatives to surgery with lack of persistent side effects, easy applicability, and reproducibility, however, recurrence rates were reported up to 50% for each. A combination of BT with topical diltiazem may provide better results in terms of healing and recurrence. In this retrospective analysis a comparison of BT injection alone and BT injection combined with topical diltiazem treatment was performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with complaints longer than 8 weeks (chronic anal fissure)
- •Patients who completed 24 months of follow-up (3rd day, 10th day, and 2nd-month face-to-face clinic visits and 6, 12, and 24 months phone calls)
- •Patients who received conservative treatments including topical diltiazem and nitrites
排除标准
- •Patients with previous anal surgery (lateral internal sphincterotomy, hemorrhoidectomy, anal fistula)
- •Patients with inflammatory bowel diseases
- •Patients with accompanying anorectal disease (hemorrhoids, anal fistula, abscess)
- •Patients who underwent botulinum toxin injection within 1 year before recruitment
- •Patients with anterior, lateral, or multiple fissures
- •Comorbidities (AIDS, sexually transmitted disease, tuberculosis, leukemia)
- •Pregnancy
- •Prescription of calcium canal blockers or nitrites
- •Hypersensitivity to diltiazem or botulinum toxin
- •Patients without anal pain
研究组 & 干预措施
Botulinum toxin group
The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters.
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
Botulinum toxin plus topical diltiazem group
The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters. After BT injection, topical 2% diltiazem gel was prescribed, applied 2 times per day for 10 days (2 doses of 1 gr each per day). No selection criteria were used when recommending this treatment; it was randomly suggested to some for a while during the cohort since the surgeon believed it might enhance the efficacy of BT.
干预措施: Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel (Drug)
结局指标
主要结局
Fissure healing at 1 month
时间窗: 1 month
Evaluation of complete epithelization of the fissure by the principal investigator by rectal examination
Days to pain-free defecation
时间窗: 1 month
Patient reported time until pain-free defecation. This will be evaluated on 3rd day, 10th day and 1-month outpatient visits.
次要结局
- Complete healing at 48 months(48 months)