Patient's Quality of Life and Functional Changes After Fistula Surgery
ConditionAnal Fistula
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMansoura University Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
both genders
Age :between 18-65 years
cryptoglandular anal fistula
need intervention
Disqualifiers
None
Trial population
patient who will be admitted in the General Surgery Department, Colorectal Surgery Unit at Mansura University hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
assessment of quality of life before and after anal surgery
Other interventionPreoperatively, 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 monthsSponsors and contacts
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Source ClinicalTrials.gov