Cross-cultural Adaptation of the Chinese Version of QoLAF-Q (Quality of Life in Patients With Anal Fistula Questionnaire) ：A Multi-center Study

NCT06962228 | Not Yet Recruiting

• 1 other identifier: QoLAF-Q
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators verify the reliability and practicality of the Chinese adaptation results of QoLAF-Q, which helps Chinese doctors better master the methods and techniques of quality of life assessment.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• Cronbach's α coefficient

  Reliability analysis was used to study the reliability and precision of the responses to quantitative data (especially the attitude scale questions).The Cronbach's α coefficient is a commonly used reliability index, which measures the correlation between various items in the scale and determines whether each item in the scale is measuring the same concept or trait. If the Cronbach's alpha coefficient is high, it indicates that the correlation among the items is strong, and the internal consistency of the scale is good, meaning that these items can relatively consistently reflect the psychological trait or concept being measured.In the reliability analysis of this study, if the Cronbach's α coefficient reaches above 0.8, it indicates that each item can effectively revolve around the core concept of "the quality of life of patients with anal fistula", and there is a high degree of consistency among these items.

  immediately after filling out the questionnaires

Secondary Outcomes (2)

• KMO value

  immediately after filling out the questionnaires

• Factor analysis of QoLAF-Q(quality of life in patients with anal fistula questionnaire)

  immediately after filling out the questionnaires

Study Arms (1)

anal fistula patients

Procedure: Anal fistula surgery

Interventions

Anal fistula surgery PROCEDURE

Anal fistula incision, anal fistula excision, anal fistula hanging

anal fistula patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

anal fistula patients who visited the anorectal surgery wards and outpatient departments of tertiary hospitals across the country

You may qualify if:

• meeting the diagnostic criteria for anal fistula in the "Diagnostic Criteria for Anal Fistula (2004 Edition)", and being diagnosed through clinical examinations, digital rectal examinations, anorectal ultrasound, MRI, and other examinations;
• being 18 years old or above;
• having clear consciousness and being able to understand and cooperate to complete the questionnaire survey;
• voluntarily signing the informed consent form.

You may not qualify if:

• having other serious anorectal diseases, such as anal fissure, rectal prolapse, colorectal cancer, etc.;
• having severe dysfunction of important organs such as the heart, liver, and kidneys;
• suffering from mental diseases or having cognitive impairments;
• having undergone anorectal surgery or other major surgeries that may affect the quality of life recently (within 3 months).

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of colorectal surgery

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 8, 2025
• Study Start: May 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share