Identifying Landmark Factors of Anal Fistulas

NCT06421129 | Completed DMC

• 1 other identifier: Number: 2024【546】
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fistulas; Anal Fistula

Keywords

anal fistula; perianal and rectal spaces; surgery

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• Sex

  between 1 January 2020 and 1 February 2023

• Duration of preoperative symptoms

  between 1 January 2020 and 1 February 2023

• Smoking history

  between 1 January 2020 and 1 February 2023

• Anesthesia method

  between 1 January 2020 and 1 February 2023

• Alcohol history

  between 1 January 2020 and 1 February 2023

Study Arms (2)

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

poor prognosis

outcomes that did not meet good prognosis criteria indicated a poor prognosis

Procedure: anal fistula surgery

Interventions

anal fistula surgery PROCEDURE

anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement

good prognosis; poor prognosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guanlin Liu: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiang Meng

  First Hospital of China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: January 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months after the completion of the experiment
• 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.

Locations

CN (1)