Patient's Quality of Life and Functional Changes After Fistula Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Elsayed, MSC
- Phone Number: 01005814872
- Email: Ahmedhos2011@gmail.com
Study Locations
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Dakahlyia
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Mansoura, Dakahlyia, Egypt, 35516
- Recruiting
- Mansoura University Hospital
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Contact:
- ahmed Elsayed
- Email: ahmedhos211@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- both genders
- Age :between 18-65 years
- cryptoglandular anal fistula
- need intervention
Exclusion Criteria:
- Patients with associated anorectal pathology (anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient quality of life changes before and after surgery with QoLAF-Q
Time Frame: 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
|
after 1 and 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the validation of arabic translation of the quesionaire
Time Frame: 3 and 5 months
|
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
|
3 and 5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD.21.08.508
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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