Anal FistulasNCT06421129
Identifying Landmark Factors of Anal Fistulas
An observational study of Anal Fistulas and Anal Fistula, run by Guanlin Liu at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistulas, Anal Fistula
- What is being tested?
- anal fistula surgery
- Type of treatment
- Surgery or procedure
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective cohort study was conducted at The First Affiliated Hospital of China Medical University
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: 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.
Read the 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
- Anal Fistulas, Anal Fistula
- Being tested
- anal fistula surgery
- Keywords
- anal fistula, perianal and rectal spaces, surgery
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anal fistula surgeryProcedure or surgery
anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: anal fistula surgery | |
| poor prognosis | outcomes that did not meet good prognosis criteria indicated a poor prognosis Receives: Procedure: anal fistula surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
history of perianal abscess and fistula
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
Age
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
History of underlying diseases
Hypertension, heart disease and diabetes (Electronic medical record collection)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: between 1 January 2020 and 1 February 2023
Fistula origin
Electronic medical record collection
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: between 1 January 2020 and 1 February 2023
Secondary outcomes (5)
Sex
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
Duration of preoperative symptoms
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
Smoking history
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
Anesthesia method
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
Alcohol history
Electronic medical record collection
Measured: between 1 January 2020 and 1 February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guanlin Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guanlin Liu, First Hospital of China Medical University
- Investigators
- Qiang Meng, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421129
- Sponsor's protocol ID
- Number: 2024【546】
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Landmark Factors of Anal Fistulas Through Predictive Modeling for Adverse Surgical Outcomes: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06421129
- Acronym / sponsor ID
- Number: 2024【546】
- Conditions
- Anal Fistulas, Anal Fistula
- Keywords
- anal fistula, perianal and rectal spaces, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Guanlin LiuUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good prognosis | – | Procedure: anal fistula surgeryA 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 |
| poor prognosis | – | Procedure: anal fistula surgeryoutcomes that did not meet good prognosis criteria indicated a poor prognosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective cohort study was conducted at The First Affiliated Hospital of China Medical University
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anal fistula surgeryanal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement | Procedure or surgery | good prognosis, poor prognosis |
Primary outcome
history of perianal abscess and fistula
Time frame: between 1 January 2020 and 1 February 2023
Electronic medical record collection
Age
Time frame: between 1 January 2020 and 1 February 2023
Electronic medical record collection
History of underlying diseases
Time frame: between 1 January 2020 and 1 February 2023
Hypertension, heart disease and diabetes (Electronic medical record collection)
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.
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.
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.
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.
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.
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.
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.
Fistula origin
Time frame: between 1 January 2020 and 1 February 2023
Electronic medical record collection
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.
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.
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.
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.
5 secondary outcomes
Sex
Time frame: between 1 January 2020 and 1 February 2023
Duration of preoperative symptoms
Time frame: between 1 January 2020 and 1 February 2023
Smoking history
Time frame: between 1 January 2020 and 1 February 2023
Anesthesia method
Time frame: between 1 January 2020 and 1 February 2023
Alcohol history
Time frame: between 1 January 2020 and 1 February 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Meng study director
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistulas and Anal Fistula, run by Guanlin Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
history of perianal abscess and fistula (time frame: between 1 January 2020 and 1 February 2023). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.