Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- number of patients with clinical improvement of symptoms
研究概览
简要总结
Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are compared with a healing rate over 92%. However, the most serious complication of this procedure is anal incontinence. To overcome these problems, continued efforts are being tried to find less invasive treatments modalities for anal fissure that is as effective as surgical therapy with lower morbidity.
详细描述
Sacral nerve stimulation has been recently tried for management of chronic anal fissure with promising results. However, the technique described is invasive with the need for surgically implantable expensive stimulator electrodes.
The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTN) by transcutaneous electrical nerve stimulation (TENS) and to compare it to the conventional LIS. This non-invasive technique has been proved to be of acceptable results in treatment of fecal incontinence and urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study.
排除标准
- •patients younger than 18 years;
- •patients with laterally located or painless fissures;
- •concurrent fistula or significant hemorrhoidal disease;
- •inflammatory bowel disease;
- •Diabetes mellitus;
- •neurological disease;
- •spinal cord lesions,
- •use of cardiac pacemaker. Males and females were considered for inclusion.
结局指标
主要结局
number of patients with clinical improvement of symptoms
时间窗: one year
Resolution of anal pain after the procedure
次要结局
- Number of patients with improvement of constipation according to Wexner constipation score(one year)
- Post-procedure patient satisfaction on VAS(one year)
- number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence(one year)
- Anal pain scores on VAS(one month)
- Number of patients with healed anal fissure(one month)
研究者
Tamer Youssef Mohamed
Tamer Youssef
Mansoura University