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Identifying Landmark Factors of Anal Fistulas

Completed
Conditions
Anal Fistulas
Anal Fistula
Interventions
Procedure: anal fistula surgery
Registration Number
NCT06421129
Lead Sponsor
Guanlin Liu
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
326
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
good prognosisanal fistula surgeryA good prognosis within 1-year post-surgery was defined as healing of the internal and external openings of the fistula, no recurrence of the fistula, no secondary perianal infection, no symptoms of incontinence, no persistent pain, and the ability of the patient to perform activities independently
poor prognosisanal fistula surgeryoutcomes that did not meet good prognosis criteria indicated a poor prognosis
Primary Outcome Measures
NameTimeMethod
Agebetween 1 January 2020 and 1 February 2023

Electronic medical record collection

perianal and perirectal space involvement-Ischioanal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected.The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

History of underlying diseasesbetween 1 January 2020 and 1 February 2023

Hypertension, heart disease and diabetes (Electronic medical record collection)

perianal and perirectal space involvement-perianal subcutaneous spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

fistula traversal through the internal and external sphinctersbetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the anal sphincters was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

perianal and perirectal space involvement-Intersphincteric anal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

Fistula originbetween 1 January 2020 and 1 February 2023

Electronic medical record collection

perianal and perirectal space involvement-Anterior superficial anal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

perianal and perirectal space involvement-Deep anterior anal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

perianal and perirectal space involvement-Submucosal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

history of perianal abscess and fistulabetween 1 January 2020 and 1 February 2023

Electronic medical record collection

perianal and perirectal space involvement-Posterior superficial anal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

perianal and perirectal space involvement-Deep posterior anal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

perianal and perirectal space involvement-Ischiorectal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

perianal and perirectal space involvement-Pelvirectal spacebetween 1 January 2020 and 1 February 2023

Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive.

Secondary Outcome Measures
NameTimeMethod
Smoking historybetween 1 January 2020 and 1 February 2023

Electronic medical record collection

Alcohol historybetween 1 January 2020 and 1 February 2023

Electronic medical record collection

Sexbetween 1 January 2020 and 1 February 2023

Electronic medical record collection

Duration of preoperative symptomsbetween 1 January 2020 and 1 February 2023

Electronic medical record collection

Anesthesia methodbetween 1 January 2020 and 1 February 2023

Electronic medical record collection

Trial Locations

Locations (1)

The First Affiliated Hospital of China Medical University

🇨🇳

Shenyang, Liaoning, China

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