Clinical Research Directory

Impact of Preoperative Bowel Preparation on Healing Outcomes in FiLaC

Background: Fistula tract laser closure (FiLaC) has emerged as a sphincter-preserving treatment for anal fistula (AF). However, the optimal role of preoperative bowel preparation (BP) in enhancing postoperative outcomes remains contentious. While some surgeons recommend enemas to empty the rectum, others ignore BP altogether due to concerns about possible contamination from enemas. Current guidelines suggest that the decision to perform BP is at the surgeon's discretion, as it is not definitively linked to healing rates. Objective: This prospective, non-randomized observational cohort study aims to evaluate whether preoperative bowel preparation significantly impacts primary healing rates following FiLaC in patients with anal fistula. Methods: One hundred consecutive patients undergoing FiLaC will be prospectively enrolled and stratified into two cohorts: Group A (BP) and Group B (no BP). Anal fistulas will be classified by Parks classification. The primary outcome is complete clinical healing at three months, defined by the absence of discharge, an epithelialized external opening, and no recurrence. Secondary outcomes include six-month healing rates, recurrence, postoperative pain, quality of life, Wexner continence scores, and complication rates. Multivariate logistic regression will be employed to control for potential confounders, including smoking status, prior seton use, and fistula complexity. Discussion: This study aims to fill the evidence gap regarding the benefits of preoperative BP in FiLaC procedures, improving perioperative protocols to optimize healing outcomes while reducing unnecessary interventions. The findings will provide clinicians with evidence-based guidance on BP strategies.

Autologous Stem Cells in the Management of Fistulating Perianal Crohn's Disease

Crohn's disease is a chronic inflammatory condition that can affect any part of the bowel which can be controlled by a combination of medical and surgical treatments but cannot be cured. A 1/3 of patients have involvement of the perianal region. There are several conditions that can affect the perianal region but the most debilitating is the presence of fistulating disease. Fistulae are small tunnels that run under the skin from the inside of the anus to skin outside the anus and are associated with the inflammatory process seen with Crohn's disease. They can cause pain, infection and discharge which adversely affects the quality of life of the patient. Surgery can be used to treat the symptoms however cure is often difficult to achieve. Stem cells have anti-inflammatory potential and have been shown to be a useful treatment for this condition in combination with effective medical therapy. The stem cells used in the studies need to be prepared 48 hours before use which limits their usage and this is not readily available in the UK. The proposed study aims to assess the feasibility of using autologous stem cells prepared with a rapid preparation system at the time of surgery, within the operating room (currently in use at Oxford University Hospitals NHS Foundation Trust (OUH) within the orthopaedic department for a different indication) for fistulating anal Crohn's disease. The stem cells are derived from the patients own bone marrow. The patients undergoing surgery would be having it done for the stem cell treatment. They will then undergo 3 follow up visits and complete questionnaires at each visit alongside a clinical assessment. This study is funded by Occtopus (Colorectal charity based in Oxford).

PRP Use in Treatment of Fistula Ano

In treatment of perianal fistula several methods are described. However, since the Hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

The Impact of Perianal Disease on Patient's Sex Life

Perianal diseases, such as perianal abcesses, anal fistulae and perianal Crohn's disease, are often associated with significant physical symptoms, including pain and chronic drainage. However, the impact of these conditions on a patient's personal life, intimacy, and body image-often referred to as "hidden morbidity"-is frequently overlooked in clinical practice. The purpose of this prospective observational study is to evaluate the psychosexual burden in patients suffering from chronic perianal disease. Using validated tools (IIEF-5 for men, FSFI-6 for women) and a specialized Supplemental Patient-Reported Outcome Measure (PROM), researchers will investigate how the presence of surgical devices (such as setons), disease etiology, and clinical symptoms affect sexual function and self-esteem. The study also aims to identify gaps in physician-patient communication regarding sexual health. By quantifying these impacts, the study seeks to promote a more holistic, patient-centered approach to the surgical management of perianal conditions.

Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas

Safety and Efficacy of ECMT-100 for the Treatment of Anorectal Fistulas

Fistula-in-ano in Infants and Children

In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease

Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).