Actively Recruiting
Patient's Quality of Life and Functional Changes After Fistula Surgery
Led by Mansoura University Hospital · Updated on 2024-08-12
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to monitor the effects of surgery for anal fistula on patients' quality of life using various validated questionnaires. Anal fistulas are classified as simple or complex, with different surgical treatments depending on the type. The study focuses on understanding how different surgical approaches impact patient well-being and function after the procedure. Participants will undergo assessment of continence using the Wexner Incontinence Score and quality of life evaluations with specific tools such as the Quality of Life in patients with Anal Fistula Questionnaire (QoLAFQ) and faecal incontinence quality of life (FIQL). Surgical techniques vary based on fistula type and patient choice, and follow-up visits occur weekly in the first month, then biweekly in the second month, and again at three and six months post-surgery to track changes. During the study, participants will have their continence and quality of life assessed before surgery and at three and six months after surgery using questionnaires like QoLAF-Q and GIQLI. The primary measure is the change in quality of life after surgery at one, three, and six months. The study also includes validation of the Arabic translation of the questionnaire. The total participation involves regular follow-up visits over six months to monitor outcomes and functional changes.
CONDITIONS
Brief Title
Patient's Quality of Life and Functional Changes After Fistula Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both genders
- Age between 18 and 65 years
- Diagnosed with cryptoglandular anal fistula
- Require intervention for anal fistula
You will not qualify if you...
- Patients with associated anorectal conditions such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, or inflammatory bowel diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical intervention for anal fistula with the technique selected based on fistula type and patient preference. This stage includes the surgery and initial recovery period.
1 surgery visit (in-person)
Duration - 6 months
Participants attend follow-up visits to assess continence and quality of life changes after surgery using validated questionnaires.
Weekly visits for 4 weeks, then biweekly visits for 4 weeks, followed by visits at 3 and 6 months postoperatively (approximately 10 visits total, in-person)
Trial Site Locations
Total: 1 location
1
Mansoura university hospital
Al Mansurah, Dakahlyia, Egypt, 35516
Actively Recruiting
Research Team
A
Ahmed Elsayed, MSC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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