Anal FistulaNCT06962228
Cross-cultural Adaptation of the Chinese Version of QoLAF-Q (Quality of Life in Patients With Anal Fistula Questionnaire) ：A Multi-center Study
An observational study of Anal Fistula, run by Changhai Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Anal fistula surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: anal fistula patients who visited the anorectal surgery wards and outpatient departments of tertiary hospitals across the country
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: A Multicenter Observational Cross-sectional Clinical Trial of Cross-cultural Adaptation of the Chinese Version of QoLAF-Q (Quality of Life in Patients With Anal Fistula Questionnaire)
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.
Read the detailed description
When the investigators conduct cross-cultural adaptation to verify the applicability of QoLAF-Q in China, the investigators also compare it with the cross-cultural adaptation results of other language versions of this scale. While verifying the reliability and practicality of the Chinese adaptation results of QoLAF-Q, the investigators also explore its differences, which helps Chinese doctors better master the methods and techniques of quality of life assessment, pay more attention to the physical and mental health of patients, improve the quality of life and satisfaction of patients, and provide a reference for the development of more scientific, effective, and practical scales.
- Conditions
- Anal Fistula
- Being tested
- Anal fistula surgery
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal fistula surgeryProcedure or surgery
Anal fistula incision, anal fistula excision, anal fistula hanging
| Study group | Role | What they receive |
|---|---|---|
| anal fistula patients | Not described Receives: Procedure: Anal fistula surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after filling out the questionnaires
Secondary outcomes (2)
KMO value
Validity analysis is used to study the rationality of the design of quantitative data (especially items in attitude scales). For the validity analysis of this scale, it is required to use the KMO value to determine whether the data obtained after converting the subjective choices of patients into Likert scale scores are reasonable and whether they can be used for factor analysis, so as to judge the appropriateness of information extraction and verify the validity level of the data.
Measured: immediately after filling out the questionnaires
Factor analysis of QoLAF-Q(quality of life in patients with anal fistula questionnaire)
The factor analysis of the Quality of Life in Anal Fistula Questionnaire (QoLAF-Q) is used to verify the applicability of QoLAF-Q in China through cross-cultural research, which includes two parts: exploratory factor analysis(EFA) and confirmatory factor analysis(CFA). EFA extracts the latent factors in the scale through methods such as principal component analysis to determine the structural dimensions of the scale.Based on EFA, CFA uses structural equation modeling to verify the structure of the scale and further evaluate the construct validity of the scale. By comparing the model fit indices, such as the chi-square to degrees of freedom ratio (χ²/df), goodness-of-fit index (GFI), etc, the degree of fit between the model and the data is judged.When the various indicators in the factor analysis of QoLAF-Q are basically higher than the predicted values, it indicates that the QoLAF has good applicability for the assessment of Chinese patients.
Measured: immediately after filling out the questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962228
- Sponsor's protocol ID
- QoLAF-Q
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Cross-sectional Clinical Trial of Cross-cultural Adaptation of the Chinese Version of QoLAF-Q (Quality of Life in Patients With Anal Fistula Questionnaire)
- ClinicalTrials.gov ID
- NCT06962228
- Acronym / sponsor ID
- QoLAF-Q
- Conditions
- Anal Fistula
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
When the investigators conduct cross-cultural adaptation to verify the applicability of QoLAF-Q in China, the investigators also compare it with the cross-cultural adaptation results of other language versions of this scale. While verifying the reliability and practicality of the Chinese adaptation results of QoLAF-Q, the investigators also explore its differences, which helps Chinese doctors better master the methods and techniques of quality of life assessment, pay more attention to the physical and mental health of patients, improve the quality of life and satisfaction of patients, and provide a reference for the development of more scientific, effective, and practical scales.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anal fistula patients | – | Procedure: Anal fistula surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- anal fistula patients who visited the anorectal surgery wards and outpatient departments of tertiary hospitals across the country
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal fistula surgeryAnal fistula incision, anal fistula excision, anal fistula hanging | Procedure or surgery | anal fistula patients |
Primary outcome
Cronbach's α coefficient
Time frame: immediately after filling out the questionnaires
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.
2 secondary outcomes
KMO value
Time frame: immediately after filling out the questionnaires
Factor analysis of QoLAF-Q(quality of life in patients with anal fistula questionnaire)
Time frame: immediately after filling out the questionnaires
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
Related trials for Anal Fistula
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Changhai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cronbach's α coefficient (time frame: immediately after filling out the questionnaires). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.