Development of screening tools to predict the risk of recurrence and related complications following anal fistula surgery: protocol for a prospective cohort study

Abstract

IntroductionPostoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.Methods and analysisThis is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.Ethics and disseminationThe study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.Trial registration numberChiCTR1900025069; Pre-results.

Efficacy and safety of traditional Chinese medicine external washing in the treatment of postoperative wound of diabetes complicated with anal fistula: Study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial

“…Diabetes mellitus is a risk factor for slow wound healing after anal fistula surgery ( Wang et al, 2014 ; Mei et al, 2019 ), which can influence the development and outcome of patients with anal fistula ( Mei et al, 2019 ). Surgery is currently the preferred treatment for anal fistula ( Andreou et al, 2020 ; Mei et al, 2020 ; Wang et al, 2021 ). However, diabetic patients with large wounds after anal fistula surgery have an increased probability of wound infection, accompanied by pain, itching, swelling, and exudation, which are not easy to heal.…”

The bared external anal sphincter (BEAS), a new technique for high horseshoe anal fistula: a hospital-based cohort study

“…Stool consistency was assessed using the 7-point Bristol stool scale 17 . Disease recurrence, as was reported by Mei et al, was defined as persistence or recurrence of symptoms or the relapse of the perianal sepsis within or more than 6 months following surgical intervention 18,19 .…”

The Bared External Anal Sphincter (BEAS), a New Technique for High Horseshoe Anal Fistula: a Hospital-based Cohort Study

“…There is no difference between these methods. The severity of fecal incontinence symptoms was evaluated using the Cleveland Clinic Florida incontinence score (CCF-IS) [17][18]. Postoperative pain was measured using an 11-point Visual Analog Scale pain score (VAS-PS) [19].…”