Anal Fissure

Researchers are evaluating the use of a second-generation colon capsule endoscopy system to detect bleeding sources in patients with severe hematochezia, which involves bright red blood per rectum. This study compares this capsule endoscopy with standard diagnostic tests like tagged red blood cell scans and angiography to see if it improves the accuracy and speed of locating bleeding lesions. The study aims to provide a new approach that could change current guidelines and management for patients with this condition. Participants will undergo bowel preparation and then swallow the colon capsule, which records images of the entire gastrointestinal tract for up to 10 hours. Alongside this, patients will receive standard tests such as tagged RBC scans, CT or MRI angiography, and urgent colonoscopy within 48 hours to identify bleeding sources. The study also includes further diagnostic procedures if needed, and specialists will review all results while blinded to the capsule endoscopy findings initially to avoid bias. During the study, researchers will collect medical history, physical exams, lab tests, and details about bleeding and treatments. Safety monitoring will track adverse events daily during hospitalization and weekly for 30 days after discharge. The main outcome measured is the ability of each diagnostic method to locate the bleeding site within 30 days. Follow-up includes monitoring treatments, complications, transfusions, hospital stay, and survival, with data kept confidential and securely managed throughout the study.

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 treatment options for patients with chronic anal fissure, a painful rupture of the anal canal mucous membrane lasting over two months and resistant to non-surgical treatments. This condition mainly affects young and able-bodied adults and is caused by spasms of the internal anal sphincter muscle. The study aims to improve treatment outcomes by reducing the frequency and duration of anal sphincter insufficiency after relieving these spasms. Participants will undergo excision of the anal fissure combined with relaxation of the internal sphincter using botulinum toxin type A. The treatment involves injecting 40 units of botulinum toxin into the internal anal sphincter at four specific locations. The study compares this combined approach to similar treatment methods and includes an additional injection of platelet-rich plasma. Patients are randomized into either the main group or control group, both receiving the same interventions. During the trial, researchers will monitor anal sphincter insufficiency over 60 days as the primary outcome. Secondary outcomes include pain intensity, wound healing, sphincter function measurements, temporary disability, and disease relapse, assessed at various intervals up to one year. Participants will be closely observed throughout these periods with clinical evaluations to track treatment effects and safety.

Researchers are evaluating topical treatments for acute anal fissure by comparing MEBO ointment, topical diltiazem (DTZ) ointment, and a combination of both. This randomized controlled trial aims to determine which treatment is more effective and safe, with the hypothesis that the combination of MEBO and DTZ may work better than either ointment alone. The study is designed as a phase 2 trial with a parallel group design and multiple assessment points. Participants will be randomly assigned to one of three groups: applying MEBO ointment, DTZ ointment, or a combination of both, each applied peri-anally three times daily for six weeks. Those who do not improve after two weeks on either MEBO or DTZ alone may switch to the combination treatment, and if they still do not improve, surgery may be offered. Treatment allocation is concealed until after consent, and the patient and physician will know the treatment, while other study personnel remain blinded. Participants will be evaluated at weeks 1, 6, and 10 after starting treatment. Assessments include pain scores, wound healing, strain during defecation, and the patient's overall impression of improvement. Patients will keep diaries recording pain and strain scores for three days before each follow-up. Safety and adverse events are monitored throughout, and data will be analyzed to compare the treatments. The total study duration per participant includes these visits and follow-ups over about 10 weeks.

Researchers are comparing two common treatments for chronic anal fissure, a painful condition causing severe discomfort during bowel movements. The study evaluates botulinum toxin injection, a minimally invasive method that temporarily relaxes the anal muscle, and lateral internal sphincterotomy, a minor surgery that permanently reduces muscle pressure. The goal is to find which treatment offers better healing and safety for patients with this condition. Participants will be divided into two groups. One group will receive 20 units of botulinum toxin type A injected into the anal sphincter at two specific points using a fine needle. The other group will undergo lateral internal sphincterotomy, where a small surgical cut is made to divide part of the anal sphincter under spinal anesthesia. This procedure allows the wound to heal naturally. Both treatments aim to relieve symptoms and promote fissure healing. During the study, 90 adult patients will be regularly checked to assess how well the fissure heals within three months, relief from pain, recurrence rates, and any side effects like incontinence. Follow-up visits will monitor healing progress and complications. The study will help determine the effectiveness and safety of each treatment over time, supporting better treatment choices for chronic anal fissure.

Researchers are evaluating three different surgical techniques of lateral internal sphincterotomy (LIS) for patients with chronic anal fissure that has not improved with medical treatment. The study aims to compare the healing rates and the occurrence of fecal incontinence among these techniques over 12 months. This trial is a prospective randomized controlled study involving 150 adult patients, assessing how different extents of sphincterotomy affect outcomes. The three techniques being compared are Spasm-Controlled LIS, which uses serial small sphincterotomies under local anesthesia and sedation until a target anal canal size is reached; LIS up to the Fissure Apex, an open procedure under spinal or general anesthesia extending to the fissure's end; and LIS up to the Dentate Line, the traditional open method extending to the dentate line, also under spinal or general anesthesia. Randomization assigns patients equally to one of these groups, and all surgeries are performed with an open technique in the lithotomy position. Participants will be evaluated before surgery and at several points after surgery including day 1, weeks 1 and 2, and months 1, 2, 6, and 12. Researchers will use the Wexner Incontinence Score to assess continence and will check for fissure healing, pain levels, recurrence, patient satisfaction, and complications. The study includes careful monitoring to compare the effectiveness and safety of the different surgical approaches over a full year.

Researchers are evaluating the efficacy and safety of treating chronic anal fissure, a painful rupture in the anal canal lasting over two months and resistant to non-surgical treatments. The study compares two treatment approaches: botulinum toxin injections and lateral subcutaneous sphincterotomy surgery. The condition mainly affects younger and working-age adults and involves internal sphincter muscle spasm as a key factor. One treatment group receives complex therapy including surgical removal of the fissure without cutting the internal sphincter, followed by injections of Botulinum Toxin Type A directly into the internal anal sphincter at four points. The other group undergoes lateral subcutaneous sphincterotomy, where the internal sphincter muscle is partially cut using a scalpel under anesthesia. Both procedures are performed under spinal anesthesia in a surgical setting. Participants will be monitored for up to 60 days after treatment. Researchers will assess anal sphincter insufficiency, pain intensity at multiple time points, wound healing, sphincter muscle function, temporary disability, and recurrence of the fissure. The study aims to understand differences in treatment effects, including frequency and duration of post-operative incontinence, by comparing these two approaches for chronic anal fissure.

Researchers are evaluating a new treatment involving E-CEL UVEC cells for adults with chronic anal fissure who have not responded to standard medical therapies. This Phase 1b trial aims to test the initial safety and potential healing effects of these genetically-engineered human umbilical vein endothelial cells injected directly around the fissure. The study is led by colorectal surgeons and seeks to observe changes in fissure healing and pain over time. Participants will receive local injections of the E-CEL UVEC cell product near the anal fissure in a series spaced 3 to 4 weeks apart. All participants receive this experimental treatment, as this is an open-label, single-arm study without a placebo group. The initial treatment and observation period lasts 6 months, followed by annual electronic questionnaires for long-term follow-up. During the study, participants will have their fissures assessed by doctors using physical examination methods accepted by the FDA. Researchers will monitor injection site reactions, pain severity during bowel movements, and wound healing progress at multiple time points up to 180 days. Safety and adverse events will be closely tracked, and participants will be asked to complete questionnaires throughout the study and during long-term follow-up.

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.