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临床试验/NCT06380036
NCT06380036已完成不适用

a Comparison of the Recurrence of Fistula in Ano After Video Assisted Fistulectomy VS. Loose Seton in Surgical Patients Having Fistula in Ano

Sairah Sadaf2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
recurrence

研究概览

简要总结

A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months

详细描述

Patients were equally allocated into two groups i.e. Group A & Group B by lottery method. In both groups, the lower bowel was emptied by an enema about an hour before the operation. All patients in Group A underwent the loose seton technique. The procedures were performed in the operating room with the patient in the lithotomy position. Probing of the fistula tract was done with a metallic malleable probe. The incision was given from the external opening of the fistula to the anal verge, involving the skin, subcutaneous tissue, superficial part of the external sphincter, and superficial part of the internal sphincter. After the insertion of loose Seton, a non-absorbable suture was left loosely and kept in situ for three months.

In group B, video-assisted fistula tract surgery (VAAFTS) was performed. The patients were positioned in the lithotomy position. The fistuloscope was then introduced into the external opening and the procedure was performed, except for the closure of the internal opening, which was performed with either a "figure of eight" suture or an advancement flap, rather than using a stapler. The tracts were destroyed using electrocautery, the necrotic tissues were removed, and the external openings were cored out and left open for drainage. The patients were discharged the day following the procedure. Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months. The information (age, gender, duration of disease, BMI, diabetes mellitus, hypertension, place of living, and recurrence) was collected through pre-designed Performa (Annexure I).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • complex fistula in ano (as per operational definition)
  • with a duration of disease >1 month,
  • either gender
  • history of previous surgery for fistula in ano

排除标准

  • Pregnant females
  • bleeding disorder
  • history of pulmonary or systemic tuberculosis

结局指标

主要结局

recurrence

时间窗: one year

to see whether recurrence occur or not

次要结局

未报告次要终点

研究者

发起方
Sairah Sadaf
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Sairah Sadaf

Classified Consultant

Sheikh Zayed Medical College

研究点 (2)

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