跳至主要内容
临床试验/CTRI/2024/04/065352
CTRI/2024/04/065352尚未招募3 期

A RANDOMIZED CONTROLLED TRIAL TO COMPARE LOCAL STEROID INJECTION VERSUS LATERAL INTERNAL SPHINCTEROTOMY BY ASSESSING VAS SCORE AND EARLY AND LATE POST-OPERATIVE COMPLICATIONS IN FISSURE IN ANO-PILOTSTUDY

Armed Forces Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
VAS Score

研究概览

简要总结

There has been much debate about the causes of primary anal fissures. Historically, the eliciting factor was considered to be the trauma resulting from the passage of hard feces, but less than 25% of the cases of chronic anal fissures are associated with constipation. Furthermore, many anal fissures of traumatic origin heal whereas others do not. For many years an association with internal anal sphincter (IAS) hypertonia has been evident, although in elderly patients  and in postpartum patients cases of anal fissure have been reported that are associated with a normal or hypotonic IAS. The basal tone of the IAS is affected by various substances, including nitric oxide (NO) . In patients with anal fissures, the synthesis of NO in the IAS is reduced in comparison with the controls . Manometry studies have demonstrated an increased IAS tone and a reduction in anodermal vascular blood flow, mainly in the posterior region  and showed that in patients who benefited from sphincterotomy surgery or from anal stretch sphincter hypertonia was reduced and blood flow increased. This pathogenetic mechanism can explain the achievement of a high rate of healing with medical therapies able to improve blood flow and/or to reduce hypertonia. Triamcinolone injection has been used effectively in levator syndrome and in chronic perianal wounds. Chronic fissure patients present with painful defecation and increase in sphincter tone leading to vicious cycle preventing healing of the fissure in ano. Lateral sphincterotomy which is the gold standard treatment for chronic fissure in ano may lead to post operative complications in the form of hematoma, abscess, fistula and complications of anaesthesia eg. urinary retention. Triamcinolone steroid injection will reduce the inflammation and help in wound healing.

This study will focus on the short and/or long term outcomes following LIS and local triamcinolone injection in chronic fissure in ano.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • (aa) 18 years of age or older (ab) Able to give informed consent (ac) All patients with chronic fissure in ano.

排除标准

  • (aa) Younger than 18 years old.
  • (ab) Unable to give informed consent.
  • (ac) Contraindications for spinal anaesthesia (ad) patients with other anal conditions – Anal fistula/ hemorrhoids.

结局指标

主要结局

VAS Score

时间窗: Post operative evening and Day 1

次要结局

  • Short term patient outcomes([ Time Frame: Measured within one month of the procedure])

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Arun Kumar M

Armed Forces Medical College

研究点 (1)

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