Clinical Research Directory

Video-Based Preoperative Education for Anxiety in Patients Undergoing Anal Fistula Surgery

This study evaluated whether video-based education before surgery could reduce anxiety and improve early recovery in patients undergoing anal fistula surgery under spinal anesthesia. A total of 72 adult patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups. The intervention group received standard preoperative information and watched an approximately 8-minute educational video explaining spinal anesthesia, the surgical procedure, pain management, and early postoperative recovery. The control group received standard verbal and written information only. The main objective was to determine whether video-based education reduced anxiety immediately before surgery, measured using the State-Trait Anxiety Inventory (STAI-S). The study also evaluated other outcomes, including anxiety measured using another questionnaire (APAIS), postoperative pain, pain medication requirements, and patients' willingness to undergo spinal anesthesia again. The study aimed to investigate whether adding a short educational video to routine preoperative counseling could improve patients' psychological preparation and early perioperative experience.

Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders. In Japan particularly, the incidence of anal lesions is high, with approximately half of patients developing fistulas or abscesses, significantly impairing quality of life (QOL). For perianal fistulizing Crohn's disease (PFCD), combined treatment with surgical intervention (e.g., seton placement) and medical therapy centered on anti-TNF agents is standard. However, challenges remain regarding efficacy rates and evaluation criteria. Novel therapies such as stem cell therapy, JAK inhibitors, and IL-23 inhibitors are gaining attention. This study using risankizumab aims to be the first in Japan to comprehensively evaluate the therapeutic efficacy of PFCD using both clinical and MRI assessments, thereby contributing to future treatment standardization and guideline development.

FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)

Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial

Open Fistulectomy vs. Laser Closure for Low Perianal Fistula

Perianal fistula is an abnormal tunnel connecting the anal canal to the perianal skin, frequently causing chronic pain, discharge, and impaired quality of life. Traditional open fistulectomy is an established treatment with high healing rates, but it leaves an open wound that requires prolonged recovery and carries a risk of anal sphincter injury. Fistula-tract Laser Closure (FiLaC) is a minimally invasive, sphincter-preserving technique that uses laser thermal energy to close the tract from within while minimizing tissue trauma. This study is a prospective, randomized controlled trial designed to compare the efficacy and safety of open fistulectomy versus laser fistulotomy in adult patients with primary low perianal fistula. Participants are randomly assigned to one of two surgical treatment groups: * Group 1: Laser fistulotomy (FiLaC) using a 1470 nm diode laser probe to seal the tract, combined with internal opening closure. * Group 2: Conventional open fistulectomy involving complete excision of the fistula tract, allowing the wound to heal by secondary intention. Patients are evaluated during surgery and followed postoperatively at 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months. The primary goals are to assess fistula healing rates and postoperative pain levels. Secondary goals include evaluating operative time, intraoperative blood loss, wound healing duration, complication rates, time to return to daily activities, fecal continence (measured by the Wexner Continence Score), and quality of life.

MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease

This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease. Fifty participants with complex draining fistulas will undergo staged surgical management followed by mirikizumab induction and maintenance therapy. The primary endpoint is combined clinical remission and radiologic response at Week 24. Participants will be followed through Week 48.

Study of ExoFlo for the Treatment of Perianal Fistulas

To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.

Laser Ablation Versus Conventional Fistulectomy for Uncomplicated Perianal Fistula

This randomized controlled trial aims to compare conventional open fistulectomy and laser ablation in the treatment of uncomplicated perianal fistula. The study will evaluate postoperative recovery time and recurrence rates between the two procedures. A total of 72 patients with uncomplicated perianal fistula will be randomly assigned to either conventional open fistulectomy or laser ablation and followed for six months after surgery.

This Study Compares the Conventional Cutting Seton Technique and a GLUBRAN®-Coated Seton in High Perianal Fistula Treatment. The Study Aims to Determine Whether the GLUBRAN®-Coated Seton Improves Healing, Reduces Postoperative Pain and Recurrence, and Better Preserves Anal Continence.

High anal fistula is a complex anorectal condition that can cause persistent pain, purulent discharge, recurrent infection, and a significant reduction in quality of life. The conventional cutting seton technique is an established treatment modality; however, it may be associated with postoperative pain, delayed healing, recurrence, and impairment of anal continence. GLUBRAN® is a synthetic surgical adhesive with antimicrobial and tissue-healing properties that may enhance the performance of the cutting seton and improve clinical outcomes. This randomized controlled clinical trial aims to compare the efficacy and safety of a conventional cutting seton with a GLUBRAN®-coated cutting seton in adult patients with high anal fistulas. Eligible participants will be randomly allocated to one of the two treatment groups and followed for six months after surgery. The primary and secondary outcome measures will include fistula healing rate, time to complete healing, postoperative pain, anal continence, recurrence, postoperative complications, and length of hospital stay. The findings of this study may provide evidence regarding whether coating a cutting seton with GLUBRAN® offers clinical advantages over the conventional technique, potentially leading to improved healing, reduced postoperative morbidity, and better preservation of anal continence in the management of high anal fistulas.

Comparison Of Surgical Outcomes Between Ligation Of Intersphincteric Fistula Tract And Fistulotomy With Seton In Perianal Fistula

This study aims to compare two commonly used surgical techniques for the treatment of perianal fistula: Ligation of the Intersphincteric Fistula Tract (LIFT) and fistulotomy with seton. Perianal fistula is a condition that can cause pain, discharge, and significant discomfort, and its treatment remains challenging due to the risk of recurrence and potential loss of bowel control after surgery. The LIFT procedure is a sphincter-preserving technique designed to treat the fistula without damaging the muscles responsible for continence. In contrast, fistulotomy with seton involves placing a thread (seton) in the fistula tract followed by gradual or staged division of the tract, which may carry a higher risk of affecting continence. In this study, 100 adult patients diagnosed with perianal fistula will be included and divided into two groups based on the surgical procedure they undergo: LIFT or fistulotomy with seton. The outcomes of both procedures will be compared in terms of wound healing time, recurrence of the fistula, postoperative pain, and preservation of bowel continence. The results of this study will help determine which surgical technique provides better recovery, fewer complications, and improved quality of life for patients.

Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease

The purpose of this study is to determine the safety and efficacy of using adult allogeneic bone marrow derived mesenchymal stem cells (MSCs), to treat people for medically refractory perianal fistulizing Crohn's disease.

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.

Role of MRI in Perianal Fistula

The aim of this study is to assess the diagnostic accuracy of MRI in detecting and assessment the primary fistulous tract, internal openings, secondary extensions, and associated abscesses. (and compare these findings with the surgical findings in patients who underwent 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.

Comparing Three Surgical Techniques for the Treatment of Transsphincteric Perianal Fistula: (1) Traditional Fistulotomy (Lay Open), (2) Ligation of the Intersphincteric Tract (LIFT) With Adjunctive Endo Fistula Laser Ablation, and (3) Open LIFT Procedure Followed by LASER

\>This randomized clinical trial compares three different surgical techniques for the treatment of transsphincteric perianal fistula: (1) traditional fistulotomy (lay open), (2) ligation of the intersphincteric tract (LIFT) with adjunctive endofistula laser ablation, and (3) open LIFT procedure followed by direct laser ablation of the tract under vision. The aim is to determine which approach offers the highest healing rate, lowest recurrence, and best postoperative outcomes with minimal impact on continence.

Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.

Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study

Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes. Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy. Study design: The design of this prospective, multicentre study is a feasibility study. Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible. Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas. Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications. Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system. Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.