Tracheoesophageal Fistula

Esophageal atresia (EA) is a common congenital condition affecting the esophagus, requiring surgical repair to survive. This research evaluates the impact of different balloon inflation times during endoscopic balloon dilation, a treatment for esophageal anastomotic strictures—a common complication after surgery that narrows the esophagus. The study aims to understand whether the duration of balloon inflation affects treatment outcomes in pediatric patients. Participants will be randomly assigned to one of two groups. Group A will receive endoscopic balloon dilation with the balloon inflated for 30 seconds, while Group B will have the balloon inflated for 180 seconds. This procedure involves placing a catheter with a balloon at the narrowed esophageal section via endoscopy and inflating it to widen the stricture. The study compares these two inflation times to assess their effects on stricture response. During the study, participants will be monitored over six months to evaluate the response of strictures to the balloon dilation and changes in the diameter of the esophageal anastomosis. Researchers will use follow-up endoscopies to measure these outcomes. The study involves regular assessments to track progress and safety, with the total participation period covering at least six months after the dilation procedure.

Obstetric fistula causes severe urinary incontinence and stigma, impacting quality of life for many women, particularly in sub-Saharan Africa. This research aims to evaluate two insertable device models for non-surgical management of urinary incontinence in women with obstetric fistula. The study will compare the effectiveness, acceptability, and costs of a vaginal cup alone and a cup connected to a urine collection bag among women awaiting fistula surgery or those with unsuccessful surgery. Participants will experience two intervention models: a vaginal cup inserted to manage leakage and the cup attached by tubing to a leg-secured urine collection bag for increased urine holding capacity. Using a randomized crossover design, 100 women will use each intervention and a no-intervention period for 24 hours each over four days. After this, participants will be re-randomized to use either the cup or cup+ at home for three months to assess long-term acceptability and outcomes. During the study, researchers will measure urine leakage volume, quality of life, stigma, sleep satisfaction, coping, empowerment, safety, and user acceptability using self-reports, clinical checklists, and interviews. Cost assessments will also be performed to understand financial impacts. The study involves multiple assessments over three months, including short-term objective measures and longer-term patient-reported outcomes, to fully evaluate device performance and user experience.

Researchers are studying the use of the Dual Action Tissue (DAT) clip, a new endoscopic device designed to close large tissue defects in the gastrointestinal (GI) tract during routine medical care. The study aims to document how well the DAT clip performs in real-world settings, focusing on its role in managing GI bleeding, perforations, fistulas, and tissue gaps following procedures such as endoscopic mucosal resection or myotomy. This observational study does not involve experimental treatments but collects data prospectively to evaluate the clip's clinical utility. The DAT clip is a specially designed three-armed device approved by the FDA, with two independently operating arms that can open up to 60 degrees to securely clamp the edges of tissue defects. It is used during standard endoscopic procedures whenever closure of a defect is needed. Patients scheduled for such procedures may have the DAT clip applied as part of their medical care. No additional clinical visits are required solely for study purposes, and follow-up care is managed according to standard medical indications. Participants will undergo their usual endoscopic procedures, during which data will be recorded about the use of the DAT clip. Researchers will track important outcomes including the rate of complete closure of tissue defects within 12 months, the success in achieving targeted therapy, procedure times, and any adverse events. The study involves no extra visits beyond routine care, and the total monitoring period extends up to one year to assess the clip's performance and safety.

This research aims to assess differences in speech outcomes between male and female patients who use a tracheoesophageal prosthesis (TEP) after total laryngectomy, a surgery removing the voice box due to advanced laryngeal cancer. It focuses on both subjective and objective measures of voice, speech, and quality of life, as prior studies indicate female patients may experience poorer outcomes compared to males. The study is conducted across multiple sites to better understand these gender disparities in voice rehabilitation after laryngectomy. Participants have undergone total laryngectomy and currently use TEP to produce speech. The study evaluates voice outcomes using multiple scales, including acoustic analysis, perceptual evaluation, and patient-reported measures. The primary outcomes include quality of life and voice handicap indexes, while secondary measures assess voice quality aspects like breathiness, sustained phonation, and fundamental frequency. Data collection is planned over approximately three years. During the study, participants will complete assessments such as the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) and the Alaryngeal Voice Handicap Index (AVHI). Voice quality will also be evaluated using GRBAS scales and phonation measurements. These evaluations will continue through the study period to monitor voice and speech function changes. The study is observational and may include healthy volunteers who meet the criteria, with participation lasting up to three years.

Researchers are studying adolescents aged 13 to 14 who were born with esophageal atresia, a birth defect where the esophagus is interrupted and ends in a dead end. Surgery is required soon after birth to restore esophagus continuity, but many children continue to experience health issues such as acid reflux, eating difficulties, breathing problems, and growth challenges throughout life. This study aims to assess the long-term outcomes and develop detailed molecular profiles of esophageal tissue and blood samples from this rare condition. The study includes two groups: adolescents with esophageal atresia and a control group without the condition. Participants undergo upper gastrointestinal endoscopy with biopsy sampling as part of their usual care. Quality of life questionnaires designed specifically for this research, including the Pediatric Quality of Life Inventory and EA-QoL, are used. Clinical and molecular data from tissue and blood samples will be analyzed together to understand disease impact and molecular changes. Data will be stored and shared through the France Cohortes platform. Participants will have their gastroesophageal reflux disease (GERD) status assessed along with measures of quality of life, nutrition, and respiratory health. Researchers will analyze molecular profiles from plasma and esophageal biopsies, and look at factors associated with GERD from birth through adolescence. Participation involves clinical data collection, questionnaires, and biological sampling during routine care. Data from this study will contribute to understanding the long-term effects of esophageal atresia and aid future research.

Researchers are evaluating two intraoperative imaging methods to assess tissue perfusion during gastrointestinal surgeries involving anastomoses. This randomized controlled trial compares a new non-contact optical technique called imaging photoplethysmography (iPPG) to the current standard, indocyanine green (ICG) fluorescence imaging. The aim is to determine how well the iPPG evaluations agree with both the visual and software-based analyses used in the ICG method, potentially refining perfusion assessment in clinical practice. Participants are randomly assigned to one of two groups. One group receives tissue perfusion assessment with the standard ICG fluorescence imaging, which requires an intravenous injection of the fluorescent dye ICG and involves both real-time visual interpretation by the surgeon and quantitative computer analysis of fluorescence data. The other group is assessed using the investigational iPPG system, which uses a conventional video camera to detect blood volume changes without any contrast agents, providing real-time perfusion maps to guide surgical decisions. During the study, participants undergo intraoperative perfusion evaluation based on their assigned method. Researchers measure outcomes including the incidence of anastomotic leaks within 30 days after surgery, comparing qualitative and quantitative assessments in the ICG group and benchmarking iPPG results against these. Additional outcomes include rates of anastomotic revision, postoperative complications, and re-interventions. The total follow-up period for measuring these outcomes is 30 days postoperatively, allowing for comprehensive evaluation of each imaging strategy's clinical utility.

This research focuses on young adults aged 18 to 30 with esophageal atresia, a condition studied through a multidisciplinary follow-up after a transitional consultation. The initiative aims to start adult medical, psychological, and social care, empower these individuals in managing their future health, and create personalized follow-up plans. This project is unique in addressing post-traumatic stress disorder (PTSD) in this population, with a 3-year analysis planned to evaluate its impact on quality of life. Participants will undergo a 3-year follow-up involving assessments of PTSD prevalence, anxiety and depression levels, quality of life, nutritional, gastrointestinal, and respiratory health. Evaluations include clinical history correlation with PTSD and thorough monitoring of somatic and psychosocial variables. The study is observational and does not involve experimental treatments, focusing on careful data collection and analysis. During the study, participants will complete questionnaires and undergo tests such as thoracic CT scans and respiratory function tests at the start and after 3 years. Researchers will track changes in weight, height, body mass index, and eating habits, alongside psychological assessments. The primary outcome is PTSD prevalence at the beginning, with secondary outcomes including anxiety, depression, quality of life, and physical health measures monitored over the study period.

Esophageal atresia is the most common birth defect affecting the esophagus, caused by abnormal development before birth. Children with this condition may face various challenges including structural problems, respiratory issues, frequent infections, and reduced physical activity, which can impact their lung function, muscle strength, exercise ability, posture, motor skills, and quality of life. This research aims to compare these physical characteristics and health measures between children with esophageal atresia and healthy children. This observational study involves two groups: children with esophageal atresia and healthy children, all aged 6 to 18 years. There is no intervention or treatment given; instead, participants undergo various assessments. These include tests for lung function, muscle strength, exercise capacity, posture, motor function, physical activity level, fatigue, frailty, and quality of life. The main evaluation happens on the first day, with exercise capacity reassessed one week later. Participants will be involved in a series of tests and measurements such as forced vital capacity, peak expiratory flow, body composition, muscle strength tests, motor function assessments, and questionnaires about fatigue and quality of life. Researchers will monitor and compare these outcomes to understand differences between children with esophageal atresia and healthy peers. The study spans from initial assessments to a follow-up exercise capacity test one week afterward, allowing detailed observation of physical health and function.

This research aims to evaluate the use of Indocyanine Green (ICG) combined with near infrared fluorescence (NIRF) imaging in babies undergoing primary or delayed primary repair of oesophageal atresia with distal tracheo-oesophageal fistula (OA/dTOF). The study investigates whether ICG/NIRF can reduce the rates of anastomotic leaks or predict which patients might develop these leaks, potentially allowing better counseling of parents and guiding further preventive strategies. Additionally, the study will assess how ICG affects peripheral oxygen and cerebral near infrared spectroscopy readings during surgery in neonates. Participants will receive ICG during their surgery, with both intravenous and enteral dosing to evaluate tissue blood flow before and after the oesophageal anastomosis. The study will observe if ICG/NIRF can identify poor blood flow or ischemia at the surgical site, which is linked to leak risk. The research includes a single treatment arm and is designed as a cohort pilot study with 20 patients to inform a future multi-center randomized trial. During the study, researchers will monitor oxygen saturation and near-infrared spectroscopy values in the babies, comparing them with arterial blood oxygen measurements from routine blood gas analysis. The main outcomes measured within two weeks after surgery will be the intravenous and enteral ICG assessments. Secondary measures include follow-up evaluations of oxygen saturation and clinical outcomes within a year. This study will last until March 2026 and is sponsored by Birmingham Women's and Children's NHS Foundation Trust.