## Protocol Section
### Identification Module
**NCT ID:** NCT06421129

**Brief Title:** Identifying Landmark Factors of Anal Fistulas

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

#### Organization Study ID Info
**ID:** Number: 2024【546】
#### Organization
**Class:** OTHER
**Full Name:** First Hospital of China Medical University
### Status Module
#### Completion Date
**Date:** 2024-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Guanlin Liu

#### Responsible Party

**Investigator Affiliation:** First Hospital of China Medical University

**Investigator Full Name:** Guanlin Liu

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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).

### Conditions Module

**Conditions:**

- Anal Fistulas

- Anal Fistula

**Keywords:**

- anal fistula

- perianal and rectal spaces

- surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 326

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Procedure: anal fistula surgery

**Label:** good prognosis

#### Arm Group 2

**Description:** outcomes that did not meet good prognosis criteria indicated a poor prognosis

**Intervention Names:**

- Procedure: anal fistula surgery

**Label:** poor prognosis

### Interventions

#### Intervention 1

**Arm Group Labels:**

- good prognosis

- poor prognosis

**Description:** anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement

**Name:** anal fistula surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Electronic medical record collection

**Measure:** history of perianal abscess and fistula

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** Electronic medical record collection

**Measure:** Age

**Time Frame:** between 1 January 2020 and 1 February 2023

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

**Measure:** History of underlying diseases

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-perianal subcutaneous space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Posterior superficial anal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Deep posterior anal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Anterior superficial anal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Deep anterior anal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Submucosal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Intersphincteric anal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** Electronic medical record collection

**Measure:** Fistula origin

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** fistula traversal through the internal and external sphincters

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Ischioanal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Ischiorectal space

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** 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.

**Measure:** perianal and perirectal space involvement-Pelvirectal space

**Time Frame:** between 1 January 2020 and 1 February 2023

#### Secondary Outcomes

**Description:** Electronic medical record collection

**Measure:** Sex

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** Electronic medical record collection

**Measure:** Duration of preoperative symptoms

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** Electronic medical record collection

**Measure:** Smoking history

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** Electronic medical record collection

**Measure:** Anesthesia method

**Time Frame:** between 1 January 2020 and 1 February 2023

**Description:** Electronic medical record collection

**Measure:** Alcohol history

**Time Frame:** between 1 January 2020 and 1 February 2023

### Eligibility Module

**Eligibility Criteria:** 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.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** This retrospective cohort study was conducted at The First Affiliated Hospital of China Medical University

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shenyang

**Country:** China

**Facility:** The First Affiliated Hospital of China Medical University

**State:** Liaoning

**Zip:** 110001

#### Overall Officials

**Official 1:**

**Affiliation:** First Hospital of China Medical University

**Name:** Qiang Meng

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**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.

**Description:** All IPD that underlie results in a publication

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Six months after the completion of the experiment

**URL:** https://clinicaltrials.gov

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000007412

- Term: Intestinal Fistula

- ID: D000016154

- Term: Digestive System Fistula

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M14845

- Name: Rectal Fistula

- Relevance: HIGH

- As Found: Anal Fistula

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M10446

- Name: Intestinal Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M18616

- Name: Digestive System Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012003

- Term: Rectal Fistula

- ID: D000005402

- Term: Fistula

### Misc Info Module

- Version Holder: 2024-05-31
