An observational study in Anal Fistula, sponsored by Changhai Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Changhai Hospital · Observational
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.
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.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 150 is above the median of 85 across 46 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
Counted across the registry records on this site, refreshed daily.
anal fistula patients who visited the anorectal surgery wards and outpatient departments of tertiary hospitals across the country
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Anal fistula surgery
Anal fistula incision, anal fistula excision, anal fistula hanging
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.
Time frame: immediately after filling out the questionnaires
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.
Time frame: 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.
Time frame: immediately after filling out the questionnaires
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Aug 2025, 3 months later.
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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