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OpenTrials
Completed

NCT Number: NCT06421129

Identifying Landmark Factors of Anal Fistulas

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anal fistula surgery

Procedure

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

Primary outcomes

  1. history of perianal abscess and fistula

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  2. Age

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  3. History of underlying diseases

    Time frame: between 1 January 2020 and 1 February 2023

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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Fistula origin

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  12. 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.

  13. 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.

  14. 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.

  15. 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

  1. Sex

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  2. Duration of preoperative symptoms

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  3. Smoking history

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  4. Anesthesia method

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

  5. Alcohol history

    Time frame: between 1 January 2020 and 1 February 2023

    Electronic medical record collection

Sponsors and collaborators

Lead sponsor

Guanlin Liu

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 20, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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