Clinical trial NCT06421129: Identifying Landmark Factors of Anal Fistulas
Official title: Identifying Landmark Factors of Anal Fistulas Through Predictive Modeling for Adverse Surgical Outcomes: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Fistulas
Anal Fistula
Keywords: anal fistula
perianal and rectal spaces
surgery
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 326
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study was conducted at The First Affiliated Hospital of China Medical University

Brief summary: The goal of this observational study is to understand the effects of anatomical factors, etiology, and complexity of anal fistula on the prognosis of patients undergoing anal fistula surgery within one year post-operation.The main question it aims to answer is:

Which factors are indicative of the prognosis of anal fistula surgery? Which factors are landmark factors of anal fistulas?

Participants who have already undergone anal fistula surgery at our hospital will receive outpatient and telephone follow-up to assess their prognosis.

Detailed description: The search function of the electronic medical record system and surgical records were used to screen patients. For the enrolled patients, the electronic medical record system, imaging report query system, medical order system, outpatient follow-up and telephone follow-up were used to collect data Data were entered into Excel 2021 (Microsoft Corp., Redmond, WA, USA) and checked for errors before conducting statistical analyses using R software (version 4.2.2; The R Foundation, Vienna, Austria).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with an anal fistula through clinical and radiological examinations; surgeries performed by physicians at our hospital who had at least a title of Associate Chief Physician, with operative records completed after surgery; patients with complete clinical data; and patients who completed post-operative outpatient follow-up and agreed to participate in telephone follow-up surveys.

Exclusion Criteria:

* Patients who were assessed clinically as unable to tolerate surgery; patients who refused surgical treatment; and patients who failed to complete the outpatient follow-up, refused telephone follow-up, or were lost to follow-up.

Primary outcomes:
measure: history of perianal abscess and fistula
timeFrame: between 1 January 2020 and 1 February 2023
measure: Age
timeFrame: between 1 January 2020 and 1 February 2023
measure: History of underlying diseases
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-perianal subcutaneous space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Posterior superficial anal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Deep posterior anal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Anterior superficial anal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Deep anterior anal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Submucosal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Intersphincteric anal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: Fistula origin
timeFrame: between 1 January 2020 and 1 February 2023
measure: fistula traversal through the internal and external sphincters
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Ischioanal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Ischiorectal space
timeFrame: between 1 January 2020 and 1 February 2023
measure: perianal and perirectal space involvement-Pelvirectal space
timeFrame: between 1 January 2020 and 1 February 2023
Secondary outcomes:
measure: Sex
timeFrame: between 1 January 2020 and 1 February 2023
measure: Duration of preoperative symptoms
timeFrame: between 1 January 2020 and 1 February 2023
measure: Smoking history
timeFrame: between 1 January 2020 and 1 February 2023
measure: Anesthesia method
timeFrame: between 1 January 2020 and 1 February 2023
measure: Alcohol history
timeFrame: between 1 January 2020 and 1 February 2023
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Qiang Meng
role: STUDY_DIRECTOR
References: