Anal Fistula

Researchers are evaluating the safety and effectiveness of a device called RD2 Ver.02 compared to a control treatment for managing transsphincteric and long intersphincteric anal fistulas. The study aims to assess the complication rate within 6 months, recurrence rates at 12 months after treatment, and the incidence of perirectal infection by 6 months. This is a prospective, multi-center, double-blind, randomized controlled trial conducted by RedDress Ltd. Participants will be randomly assigned to one of two groups. Both groups will undergo debridement of the fistula tract, suturing of the internal opening, and a water leak test to ensure sealing. In the treatment group, the patient's own coagulating blood (RD2 Ver.02) will be applied inside the fistula tract to serve as a provisional matrix. In the control group, the blood sample will be discarded, and saline will be applied instead. Treatments are performed in the operating room. Participants will be monitored for healing and complications through 6 to 12 months post-treatment. The primary outcome is the combined healing rate of anal fistulas at 6 months. Secondary outcomes include clinical recurrence at 12 months and incidence of perirectal infections at 6 months. Blood samples, clinical evaluations, and imaging (pelvic MRI) are used to assess eligibility and monitor safety and efficacy. The trial will continue enrollment and follow-up until June 2028.

Researchers are studying the best combination of treatments to achieve complete healing of anal suppurations caused by Crohn's disease within 12 months. The study focuses on improving patient outcomes by combining immunosuppressants, biologic therapies, antibiotics, surgical drainage, and reconstruction procedures. It aims to better define treatment strategies based on patient characteristics and to evaluate healing not only by clinical exam but also by MRI imaging. Participants may receive surgical treatment such as drainage or reconstruction of anal suppurations depending on the doctor's decision. The study observes therapeutic responses and healing through clinical examination and MRI evaluations, emphasizing the importance of imaging in monitoring the effectiveness of treatments. The research is designed as a large prospective national cohort to identify prognostic factors and optimal therapeutic responses. During the study, participants will be monitored over 12 months to assess clinical and anatomical healing of their anal fistulas. Data collected include clinical assessments and MRI scans to evaluate the inflammatory status and anatomical healing of the lesions. The study involves follow-up visits to track treatment outcomes and ensure preservation of anal function. Participant involvement includes receiving planned drainage procedures and following the treatment and monitoring schedule set by their healthcare providers.

Researchers are evaluating the long-term durability and effectiveness of the BioHealx Anal Fistula Device in closing fistula-in-ano, which involves both internal and external fistula openings. This post market surveillance study is a single-arm, multicenter trial designed to observe outcomes after treatment with this device. Participants will have their anal fistula treated with the BioHealx device, a bioabsorbable implant that securely closes the internal fistula opening to prevent reinfection while allowing drainage through the external opening during healing. The study monitors participants over time to assess fistula closure and recurrence rates. During the study, participants will be followed up regularly for up to 36 months. Researchers will measure successful closure repair at 12 months and track non-recurrence incidence at 24 and 36 months. Secondary outcomes include assessments of fecal incontinence quality of life, severity index scores, general health-related quality of life, pain scores, and use of analgesics and antibiotics. Participants will have ongoing evaluations and follow-up contacts to monitor these outcomes.

This research aims to understand the care pathways currently available for women who develop incontinence related to obstetric anal sphincter injuries (OASI) after vaginal delivery. OASI includes severe perineal tears that affect the muscles controlling bowel function and can lead to distressing symptoms like fecal and urinary incontinence. Because many affected women may not openly share their symptoms, it is important to identify if adequate follow-up and care are provided to support them and prevent long-term complications. The study focuses on women who have sustained grade 3 or 4 perineal tears during childbirth and are experiencing symptoms of anal or fecal incontinence within five years of delivery. Additionally, the study involves obstetricians and urogynaecologists who care for these patients in the UK. Participants will be asked about their experiences and perceptions of the care they have received, and healthcare providers will share their views on the care pathways and multidisciplinary team involvement. Participants will provide feedback on the quality of follow-up care over a 12-month period using interviews and surveys. The study collects detailed accounts of symptoms and quality of life impacts from women, while also assessing healthcare providers' perspectives on care provision. This information will help understand gaps and improvements needed in managing OASI-associated incontinence and ensuring supportive care is accessible and effective.

Researchers are evaluating the use of a drug retention enema containing triethanolamine cream to prevent acute radiation rectal injury in patients undergoing pelvic or rectal radiotherapy. This real-world, prospective, multicenter study aims to assess both the safety and effectiveness of this treatment in preventing radiation-induced rectal damage. Participants receive a triethanolamine cream retention enema once every night before bed during the course of radiotherapy. After completing radiotherapy, the enema is continued once nightly for an additional three months. The enema is prepared by mixing 15ml of triethanolamine cream with 30ml of normal saline and administered via a special catheter inserted about 15cm into the rectum, with the liquid retained overnight. During the study, researchers will monitor the timing and occurrence of acute and chronic radiation rectal injuries for up to approximately four months. Clinical symptoms will be assessed alongside quality of life measurements using the Inflammatory Bowel Disease Questionnaire (IBDQ). Participants' compliance and cooperation will be closely observed throughout the study period. The study is led by Fujian Cancer Hospital and began in June 2024.

Researchers are evaluating treatments for high fistula-in-ano (FIA), a challenging condition for surgeons aiming to close fistulas while preserving continence. This trial compares two procedures: collagen paste injection and mucosal advancement flap, to see which better promotes fistula healing with fewer complications. The study addresses the need for effective, sphincter-preserving options due to limitations and side effects of current surgical methods. The trial involves two treatment groups. One group receives collagen paste injection after removal of a seton drain and de-epithelialisation of the fistula tract. This paste is a porcine-derived collagen matrix designed to promote healing and reduce dislodgement. The other group undergoes mucosal advancement flap surgery, where the internal fistula opening is excised and covered with a "U-shape" rectal mucosal flap. Both approaches aim to close the fistula while preserving anal sphincter function. Participants are adults diagnosed with high cryptoglandular fistula-in-ano who have been treated with a draining seton for at least six weeks. During the study, clinical healing of the fistula will be assessed at one year, along with secondary outcomes such as complications within 30 days, quality of life, pain after one week, fecal incontinence, and hospital readmission rates. The study includes follow-ups and monitoring to evaluate both effectiveness and safety over a year.

Researchers are evaluating the safety and effectiveness of increasing doses of DB-3Q, a biological treatment derived from bone marrow mesenchymal stem cells, for adults with Perianal Fistulizing Crohn's Disease. This is a phase 2a, double-blind, randomized, placebo-controlled clinical trial sponsored by Direct Biologics, LLC, aiming to better understand treatment impact on this challenging condition. Participants will receive a single dose of DB-3Q or placebo, administered either as a 15 mL or 30 mL direct injection, or a combination of 15 mL intravenous and 30 mL direct injection. The study uses a sequential cohort design with escalating doses to assess different treatment levels. Placebo groups receive matching saline injections. The trial includes several groups to compare these dosing approaches under tightly controlled conditions. During the study, participants undergo screening including pelvic MRI reviewed by a central radiologist to confirm fistula characteristics. Researchers assess combined remission rates at 12 and 24 weeks to measure treatment response. Safety and efficacy are closely monitored throughout the trial, with follow-up visits and evaluations planned to track participant progress over time. The study runs until the end of 2027 and involves adults aged 18 to 75 with active fistulas despite prior therapies.

Researchers are evaluating the safety of endothelial cells derived from human umbilical veins as an additional treatment alongside fistulotomy surgery for patients with simple anal fistulas. These specially engineered cells, called E-CEL UVEC, are designed to improve healing after surgery. The study aims to assess the preliminary safety of these cells and observe their effects on fistula healing, based on promising animal study results. Participants with simple anal fistulas undergoing fistulotomy may receive injections of E-CEL UVEC cells directly into the fistula area during surgery. Different parts of the study involve various treatment approaches, including injection without fistulotomy or multiple injections over several months, with doses carefully controlled. Some participants may receive up to six treatments over a six-month period, with injections targeting both sides of the fistula tract and the internal opening. During the study, participants will be monitored for safety by tracking any treatment-related adverse events within two weeks after administration. Researchers will also evaluate the rate of fistula relapse and healing success over 6 to 24 weeks after surgery. Assessments include fistula leakage and time to complete healing. The study involves regular treatment visits and follow-up assessments, with ongoing safety oversight throughout the trial period.

This research aims to evaluate how the Enhanced Recovery After Surgery (ERAS) protocol affects the occurrence of postoperative urinary retention (POUR) in patients undergoing surgery for benign anorectal conditions such as chronic anal fissure, hemorrhoids, and fistula-in-ano. The study includes adult patients aged 18 to 90 years but focuses on those up to 65 years old. It compares the ERAS protocol with routine preoperative care to understand its role in reducing urinary retention after surgery. Participants will be randomly assigned to one of two groups: the ERAS pathway or the routine care pathway. The ERAS protocol includes 14 specific items based on existing guidelines, such as preoperative education, dietary restrictions before surgery, administration of saddle anesthesia, and controlled fluid management during surgery. The routine pathway represents standard preoperative procedures that may include some ERAS elements but do not require all 14 items to be followed. Throughout the study, all patients will be monitored by a phone call 72 hours after surgery and followed up in the outpatient department for 30 days. They will be advised to seek care at any time if they experience any complications. The primary measure of success is the incidence of urinary retention within 72 hours after anorectal surgery, with ongoing safety and recovery assessments during the follow-up period.

Researchers are evaluating how listening to standardized music sequences before and after proctologic surgery affects postoperative pain. This study focuses on patients undergoing surgery for hemorrhoids, fistulas, or anal fissures. The trial aims to understand whether preoperative and postoperative music can help manage pain, reduce the need for pain medications, and improve quality of life after surgery. Participants are randomly assigned to one of two groups. One group listens to relaxing, standardized music sessions via the Music Careae app, with a 20-minute session before surgery in the hospital and daily 20-minute sessions at home for 28 days after surgery. The control group receives standard care without music therapy. All music sessions allow participants to choose their preferred style, tempo, and tracks. During the study, participants will be closely monitored for pain and anxiety levels from hospitalization through 28 days post-surgery. Researchers will assess pain intensity immediately after surgery in the recovery room and track analgesic use, healing time, quality of life, patient satisfaction, and hospital stay duration. The study lasts 28 months overall, with each participant followed for 28 days.