Clinical Research Directory

Impact of Surgical Timing on Anal Fistula Outcomes

This study aims to evaluate if the amount of time a person experiences symptoms of an anal fistula before having surgery affects their surgical outcomes and recovery. An anal fistula is a chronic condition that typically requires surgery to heal properly. In routine clinical practice, many patients experience a significant delay before getting surgery due to a variety of reasons, such as under-reporting symptoms, misdiagnosis, or prolonged conservative treatments. Doctors want to understand if this delay in surgical intervention allows ongoing infection and scarring to complicate the surgery and worsen the patient's recovery. To investigate this, researchers will observe 90 adult patients who are undergoing definitive surgery for a primary anal fistula. The participants will be divided into three groups based on how long they had symptoms before their operation: 3 months or less Between 3 and 6 months More than 6 months The main goal of the study is to compare these groups to see how many patients achieve complete clinical healing and how many experience a recurrence (the fistula returning) within 12 months after the surgery. Additionally, the study will track secondary outcomes, including how long it takes the wound to heal completely, any postoperative complications, changes in bowel control (fecal incontinence), pain resolution, and the patient's overall postoperative quality of life. The findings will help inform both doctors and patients on the optimal timing for anal fistula surgery.

Recurrence and Anal Fistula Patient Reported Outcomes Trial

Perianal fistulas are a chronic anorectal condition associated with significant morbidity, including pain, persistent discharge, infection, and impaired continence, all of which can substantially affect patients' quality of life. Surgical management aims to eradicate the fistulous tract while preserving anal sphincter function and continence. Despite numerous available surgical techniques, high-quality comparative evidence regarding optimal management remains limited. This prospective observational study aims to evaluate clinical outcomes, functional outcomes, and patient-reported quality of life following surgical treatment of perianal fistulas. The study will collect both clinician-reported and patient-reported outcomes over a 12-month follow-up period. Outcomes of interest include fistula healing, recurrence, postoperative complications, continence status, symptom burden, and health-related quality of life. The findings are expected to provide real-world data that may inform clinical decision-making and contribute to improved patient-centered care.

Myriad™ Augmented Soft Tissue Reconstruction Registry

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing

The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%. These abnormal connections between the rectum and the outside skin remain a major clinical challenge in need of new treatments aimed at tissue repair. Platelet-derived growth factor drives wound healing and tissue regeneration, and manufactured PDGF is currently used to heal diabetic foot ulcers and regenerate bone in periodontal and orthopedic patients. Manufactured recombinant human PDGF has the potential to improve the success rate for complete healing of complex perianal fistulas, reduce the recurrence rate due to reopening of the fistula tract, and avoid complications associated with routine surgical interventions.

Determining the Effect of Education Given to Patients Undergoing Outpatient Anal Fistula Surgery

It is emphasized that discharge education should shift from traditional healthcare provider-centered, one-way education to patient-centered education based on patient-care provider interaction to ensure patients' active participation in their own care, adherence to the recommended treatment plan, and maintenance of surgical success after outpatient anal fistula surgery. In this context, it is suggested that an effective education method such as teach-back can be used in clinical settings to teach patients complex health information and facilitate their understanding of discharge education. While studies exist in the literature evaluating the impact of health literacy after general surgery, no studies have been found specifically evaluating health literacy and discharge education for anal fistula surgery. Furthermore, it is emphasized that further research is needed to improve the quality of postoperative care after anal fistula surgery and to better understand the factors contributing to unplanned hospital returns. Based on this need, this study is a randomized controlled trial with a pretest and posttest approach aimed at determining the effect of teach-back-based discharge education on hospital readmission and patient satisfaction in outpatient anal fistula surgery patients. The study sample was calculated as a total of 68 people, 34 in each group, based on a power analysis performed with the GPower 3.1. 9.7 program, using a type 1 error of 0.05, a type 2 error of 0.20, and an effect size of 0.70 to determine the difference in measurements between the groups. Considering the possible attrition in the study, the sample size was increased by 10%, and a total of 76 people, 38 in each group, were planned to be included in the study. Following Ethics Committee approval and institutional permissions, the study data will be collected using the Individual Identification Form, Health Literacy Scale, Anal Fistula Surgery Discharge Education Knowledge Test, Discharge Satisfaction Scale, and Post-Discharge Follow-up Form, from patients scheduled for and undergoing outpatient anal fistula surgery at Muğla Training and Research Hospital between November 15, 2025, and January 30, 2027. The research will be conducted in three phases: the development of the education brochure and knowledge test, and the preoperative and postoperative phases. The "Anal Fistula Surgery Discharge Education Knowledge Test" was developed to assess patients' knowledge of anal fistula and its care. The "Anal Fistula Surgery Discharge Education Patient Booklet" was developed by the researchers using literature review and consultation with a General Surgery Specialist specializing in anal fistulas to provide specific training on anal fistula surgery and postoperative care. These were then sent to specialists for expert opinion. All patients presenting to the General Surgery Outpatient Clinic for anal fistula surgery who meet the inclusion criteria will be interviewed face-to-face before surgery to be informed about the study. Patients who agree to participate will be asked to sign a consent form. Because outpatient surgeries involve admission and discharge within 24 hours, and patients arrive at the Proctology Unit on the day of surgery, all patients will be summoned to the General Surgery Outpatient Clinic the day before surgery and will complete the "Individual Identification Form," "Health Literacy Scale," and "Anal Fistula Surgery Discharge Education Knowledge Test." Patients will be assigned to the intervention (discharge education via teach-back) and control groups using a block randomization table based on their order of admission to the Proctology Unit for the surgical procedure. Patients in the intervention group will receive discharge education via teach-back using the "Anal Fistula Surgery Discharge Education Patient Booklet." Education will continue until the patient accurately recounts the information to the principal investigator and is confident that the patient has understood the instruction correctly. The control group will receive standard patient education in the clinic and will not receive any intervention. Postoperatively, all patients in both groups will complete the "Anal Fistula Surgery Discharge Education Knowledge Test" post-test and the Discharge Education Satisfaction Scale before being discharged from the unit. Patients in both groups will be contacted weekly for 30 days to monitor their progress. Because the study will provide training, blinding of the assessments will not be possible.

E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.

A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas

The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract.

Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist. The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment. The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.

Study on the Mechanism of Zuoqing San Promoting Postoperative Wound Healing of Anal Fistula by Inhibiting ROS-dependent NETosis

This study adopted a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of Zuoqing San fumigation and washing on the wound healing after anal fistula surgery.

Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.

Anal Fistula refers to an abnormal infectious fistula tract between the anorectum and the perianal skin. The prevalence of anal fistula is approximately 8.6 cases per 100,000 individuals. It can occur at any age but is relatively more common in individuals aged 20-40 years, with a higher incidence in males than females. Postoperative wound management is a critical component of the overall treatment for anal fistula patients. Regular postoperative wound care, such as dressing changes, can reduce recurrence rates, alleviate pain, and shorten hospitalization time. However, postoperative pain remains a major challenge in wound management following anal fistula surgery. This is largely attributed to inadequate current postoperative analgesic protocols. With ongoing advancements in local anesthetics, liposomal bupivacaine has been applied for postoperative analgesia. It offers higher bioavailability and a prolonged half-life, providing up to 72 hours of sustained analgesic effect. Given the limitations of existing analgesic strategies for post-anal fistula surgery, developing more effective pain management approaches to reduce postoperative pain holds significant clinical importance. Therefore, the investigators propose that a repeat-dosing strategy based on liposomal bupivacaine may provide superior postoperative pain control for anal fistula patients. To investigate this, the investigators designed a prospective, multicenter, randomized, open-label, controlled clinical trial. This study aims to evaluate the efficacy and safety of repeat-dose liposomal bupivacaine for postoperative analgesia following anal fistula surgery, thereby generating high-level evidence to support its clinical application in this context.

Machine Learning-Based Risk Stratification for Fistula Formation After Perianal Abscess Drainage

This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll.

Cross-cultural Adaptation of the Chinese Version of QoLAF-Q (Quality of Life in Patients With Anal Fistula Questionnaire) ：A Multi-center Study

The investigators verify the reliability and practicality of the Chinese adaptation results of QoLAF-Q, which helps Chinese doctors better master the methods and techniques of quality of life assessment.

Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions

This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.

Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells. The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy. This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed. Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided. An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities. We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.

Tissue Therapy of Transsphincteric Anal Fistula

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

Patient's Quality of Life and Functional Changes After Fistula Surgery

This is a prospective observational study that will monitor the effects of surgery for anal fistula on the patient quality of life using many valid questionnaires

Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula

Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula

To evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula To asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula