Skip to main content
Clinical Trials/NCT06421129
NCT06421129CompletedNot Applicable

Identifying Landmark Factors of Anal Fistulas Through Predictive Modeling for Adverse Surgical Outcomes: a Retrospective Cohort Study

Guanlin Liu1 site in 1 country326 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
326
Locations
1
Primary Endpoint
Age

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Age

Time Frame: between 1 January 2020 and 1 February 2023

Electronic medical record collection

perianal and perirectal space involvement-Ischioanal space

Time Frame: between 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 diseases

Time Frame: between 1 January 2020 and 1 February 2023

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

perianal and perirectal space involvement-perianal subcutaneous space

Time Frame: between 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 sphincters

Time Frame: between 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 space

Time Frame: between 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 origin

Time Frame: between 1 January 2020 and 1 February 2023

Electronic medical record collection

perianal and perirectal space involvement-Anterior superficial anal space

Time Frame: between 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 space

Time Frame: between 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 space

Time Frame: between 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 fistula

Time Frame: between 1 January 2020 and 1 February 2023

Electronic medical record collection

perianal and perirectal space involvement-Posterior superficial anal space

Time Frame: between 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 space

Time Frame: between 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 space

Time Frame: between 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 space

Time Frame: between 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 Outcomes

  • Alcohol history(between 1 January 2020 and 1 February 2023)
  • Smoking history(between 1 January 2020 and 1 February 2023)
  • Sex(between 1 January 2020 and 1 February 2023)
  • Duration of preoperative symptoms(between 1 January 2020 and 1 February 2023)
  • Anesthesia method(between 1 January 2020 and 1 February 2023)

Investigators

Sponsor
Guanlin Liu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Guanlin Liu

Principal Investigator

First Hospital of China Medical University

Study Sites (1)

Loading locations...

Similar Trials