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临床试验/NCT06548724
NCT06548724招募中不适用

Patient's Quality of Life and Functional Changes After Fistula Surgery

Mansoura University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
patient quality of life changes before and after surgery with QoLAF-Q

研究概览

简要总结

This is a prospective observational study that will monitor the effects of surgery for anal fistula on the patient quality of life using many valid questionnaires

详细描述

Anal fistulas can be classified as simple or complex. Simple anal fistula includes low trans-sphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter fibers. On the other hand, complex anal fistulas comprise, high trans-sphincteric fistulas, suprasphincteric, extrasphincteric fistulas

Patients with anal fistula often complain of recurrent perianal discharge and pruritus ani. Sometimes recurrent abscesses develop due occlusion of the external opening leading to episodes of fever and exquisite perianal pain. Diagnostic modalities that aid in the diagnosis of anal fistula include fistulography, endorectal ultrasonography, MR Fistulography

While the treatment of simple anal fistula is usually straightforward with fistulotomy being recommended as the first line of treatment ; the management of more complex cases requires more sophisticated treatments aiming to preserve the anal sphincters and to eradicate the fistulous track. Surgery for complex anal fistula includes the placement of Seton, anal advancement flap, laser ablation, fistula plug, and video-assisted anal fistula treatment. There exists a debate about the optimal management of low anal fistula with both fistulectomy and fistulotomy considered as viable options for treatment. Fistulectomy involves complete excision of the fistulous tract, eliminating the risk of missing secondary tracts and providing complete tissue for histopathological examination. On the other hand, fistulotomy involves lay open of the fistulous tract, thus leaving smaller unepithelized wounds, which hastens the wound healing . A recent meta-analysis found no significant difference between both procedures regarding recurrence of anal fistula, yet with accelerated healing time in favor of fistulotomy .Recently, alternative therapies have been employed in the management of cryptogenic anal fistula in an attempt to render the surgery more minimally invasive and to reduce the likelihood of post-operative fecal incontinence .

These treatments have included ligation of the intersphincteric fistula tract (the LIFT procedure) either with or without the deployment of a biosynthetic mesh , or fistula clip closure techniques , and a range of endo-fistula therapies including video-assisted anal fistula treatment (VAAFT) , anal fistula plugs , and a variety of injected biomaterials

, The ''Fistula Laser Closing'' (FiLaCTM) device (Biolitec, Germany) is another endo-fistula management technique . There is few studies assessing the changes in quality of life that occurs after fistula surgery whatever its technique and the aim of this study is t assess the impact of intervention for fistula on patient's quality of life

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both genders
  • Age :between 18-65 years
  • cryptoglandular anal fistula
  • need intervention

排除标准

  • Patients with associated anorectal pathology (anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.)

结局指标

主要结局

patient quality of life changes before and after surgery with QoLAF-Q

时间窗: after 1 and 3 and 6 months

To Evaluate the impact of the fistula surgery on quality of life , the range range between 14 points which means zero impact on the quality of life and 70 which is the highest impact of anal fistula on the quality of life functional aspect in form of incontinence and quality of life of the patient

次要结局

  • the validation of arabic translation of the quesionaire(3 and 5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed hossam Elsayed

assistant lecturer of general and Colorectal surgery

Mansoura University Hospital

研究点 (1)

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