An observational study in Anal Fistula, sponsored by Mansoura University Hospital. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Mansoura University Hospital · Observational
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
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
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 70 is below the median of 85 across 46 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →Mansoura University Hospital is the lead sponsor of 50 studies on the registry; 7 are open to participants now.
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patient who will be admitted in the General Surgery Department, Colorectal Surgery Unit at Mansura University hospital
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Exclusion Criteria:
Preoperatively, the state of continence will be assessed using Wexner Incontinence Score (WIS) . Also, the basal state of quality of life (QoL) will be assessed using a validated disease-specific tool known as Quality of Life in patients with Anal Fistula Questionnaire (QoLAFQ) (Ferrer-Márquez et al., , faecal incontinence quality of life (FIQL) Surgical Techniques: The selection of surgical technique depends on the type of fistula , patient choice and commitment to guidelines . Follow-up Patients will be followed-up in the outpatient clinic weekly in the first month, then every two weeks in the second month, then at 3, and 6 months postoperatively. The continence state and QoL change will be assessed using QoLAF-Q and GIQLI 3 months and6 months postoperatively.
patient quality of life changes before and after surgery with QoLAF-Q
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
Time frame: after 1 and 3 and 6 months
the validation of arabic translation of the quesionaire
The validation of the arabic translation of the questionaire will be done to establish a avalidated form in arabic that can be easily undrestandable for arabic population . it will be done on part of participants in a time frame of 4 to 5 months QoLAF-Q. In addition, postoperative pain, state of continence, manometric changes, operation time, time to healing, and postoperative complications
Time frame: 3 and 5 months
Started Aug 2021 (actual). Primary completion is estimated for Nov 2024, 39 months after the start.
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Mansoura University Hospital