Identifying Landmark Factors of Anal Fistulas

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06421129
• Other study ID #: Number: 2024?546?
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: First Hospital of China Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Anal Fistulas
• Fistula
• Rectal Fistula

Intervention

Procedure:
• anal fistula surgery
anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Guanlin Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	history of perianal abscess and fistula	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Primary	Age	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Primary	History of underlying diseases	Hypertension, heart disease and diabetes (Electronic medical record collection)	between 1 January 2020 and 1 February 2023
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Fistula origin	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Primary	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
Primary	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
Primary	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
Primary	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	Sex	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Secondary	Duration of preoperative symptoms	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Secondary	Smoking history	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Secondary	Anesthesia method	Electronic medical record collection	between 1 January 2020 and 1 February 2023
Secondary	Alcohol history	Electronic medical record collection	between 1 January 2020 and 1 February 2023