Identifying Landmark Factors of Anal Fistulas Through Predictive Modeling for Adverse Surgical Outcomes: a Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Age
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Age
时间窗: between 1 January 2020 and 1 February 2023
Electronic medical record collection
perianal and perirectal space involvement-Ischioanal space
时间窗: 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.
History of underlying diseases
时间窗: 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
时间窗: 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 traversal through the internal and external sphincters
时间窗: 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-Intersphincteric anal space
时间窗: 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
时间窗: between 1 January 2020 and 1 February 2023
Electronic medical record collection
perianal and perirectal space involvement-Anterior superficial anal space
时间窗: 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
时间窗: 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
时间窗: 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.
history of perianal abscess and fistula
时间窗: between 1 January 2020 and 1 February 2023
Electronic medical record collection
perianal and perirectal space involvement-Posterior superficial anal space
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Alcohol history(between 1 January 2020 and 1 February 2023)
- Smoking history(between 1 January 2020 and 1 February 2023)
- Sex(between 1 January 2020 and 1 February 2023)
- Duration of preoperative symptoms(between 1 January 2020 and 1 February 2023)
- Anesthesia method(between 1 January 2020 and 1 February 2023)
研究者
Guanlin Liu
Principal Investigator
First Hospital of China Medical University