跳至主要内容
临床试验/CTRI/2026/02/104511
CTRI/2026/02/104511尚未招募2/3 期

Randomized control trial on unilateral vs bilateral lateral internal sphincterotomy in a case of chronic fissure in ano

Armed forces medical college1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
160
试验地点
1
主要终点
To compare the recurrence rate

研究概览

简要总结

Gold standard treatment for chronic anal fissure is LIS, which is usually performed at single location, this study compares unilateral vs bilateral open LIS. Anal fissure is a painful linear mucosal tear situated in distal anal canal just below dentate line to anal verge, affects all ages and both sexes. Patient characteristically presently with pain, brigh red bleeding, mucosal discharge and constipation. Injury to anal mucosa by hard stools is the initiating event in the developement of fissure. Fissures classified into acute and chronic and into primary and secondary based on the pathogenesis. Chronicity criteria is duration of symptoms more than 8 weeks, presence of sentinal tag or ulcer with exposed internal sphincter. Aim is to reduce the sphicter tone which in turn increases vascularity, with medical (GTN, CCB, BOTULINUM TOXIN)  or surgical intervention(LIS).

Internal sphincter is formed by circular muscle fibers, dividing it at one point of the circle relaxes the tone of the sphincter, which is the rationale for doing unilateral LIS. Dividing the sphicter, which is rationale for doing unilateral LIS. Dividing the sphincter at two places relaxes the sphicter effectively and helps in healing faster and recovery. However risk of incontinence may increase.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All the patients of chronic fissure in Ano for more than 3 months recurrence in already optd LIS patients IBD.

排除标准

  • any previous history of rectal and perianal surgeries Patient with associated complaints of hemarrhoids, fistula in Ano, anal polyp and anorectal prolapse.

结局指标

主要结局

To compare the recurrence rate

时间窗: 03 months

次要结局

  • to compare quality of life, post op pain & incontinence(3 months)

研究者

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

Muthamizh S

AFMC, Pune

研究点 (1)

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