Identifying Landmark Factors of Anal Fistulas

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

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.

Study Overview

• Status: Completed
• Conditions: Anal Fistula; Anal Fistulas
• Intervention / Treatment: Procedure: anal fistula surgery

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 Type: Observational
• Enrollment (Actual): 326

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Affiliated Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study was conducted at The First Affiliated Hospital of China Medical University

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
good prognosis; A 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	Procedure: anal fistula surgery; anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement
poor prognosis; outcomes that did not meet good prognosis criteria indicated a poor prognosis	Procedure: anal fistula surgery; anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
history of perianal abscess and fistula	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Age	Electronic medical record collection	between 1 January 2020 and 1 February 2023
History of underlying diseases	Hypertension, heart disease and diabetes (Electronic medical record collection)	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-perianal subcutaneous space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Posterior superficial anal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Deep posterior anal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Anterior superficial anal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Deep anterior anal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Submucosal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Intersphincteric anal space	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.	between 1 January 2020 and 1 February 2023
Fistula origin	Electronic medical record collection	between 1 January 2020 and 1 February 2023
fistula traversal through the internal and external sphincters	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Ischioanal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Ischiorectal space	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.	between 1 January 2020 and 1 February 2023
perianal and perirectal space involvement-Pelvirectal space	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.	between 1 January 2020 and 1 February 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Duration of preoperative symptoms	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Smoking history	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Anesthesia method	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Alcohol history	Electronic medical record collection	between 1 January 2020 and 1 February 2023

Collaborators and Investigators

• Sponsor: Guanlin Liu
• Investigators: Study Director: Qiang Meng, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: surgery; anal fistula; perianal and rectal spaces
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: Number: 2024【546】

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Six months after the completion of the experiment
• IPD Sharing Access Criteria: This study contains clinical data from medical records in our hospital. The datasets used and/or analysed during the current study are available from the study leader on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No