View clinical trials related to Esophageal Fistula.
Filter by:Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT). Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages. Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial.
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.
In the present study, the investigator aim to evaluate the prevalence, factors affecting outcome and the outcome of neonates with tracheoesophageal fistula.
This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are: - Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen. - Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development. - Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.
Aim of this study was to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in Italian language by checking the inter- and intra-rater reliability. The validation of the tool involved the following steps: 1) Translation and adaptation of the SToPS into Italian language; 2) Recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (SLTs) and 6 Ear, Nose, and Throat (ENTs) surgeons - classified into experienced or not at assessing voice; 3) Recording of patients' speech samples; 4) Perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) Statistical analysis (quadratic weighted Cohen Kappa and weighted Kappa of Light coefficients). SLTs with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. For all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. Exclusively for experienced SLTs, only the "Impairment of social acceptability" parameter reached a good level of inter-rater agreement. In conclusion, the Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs may be considered the optimal judges for tracheoesophageal voice assessment.
This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared fluorescence (NIRF) can decrease the rates of anastomotic leaks and/or predict which patients they will happen in. The latter evaluation would help counsel parents and mean that further research can evaluate if other tactics can prevent the leak being a moderate or severe problem. These may include, but not be limited to, extra anastomotic sutures, insertion of a chest drain at the time of surgery (if this had not previously been considered) delaying oral feeding or using medications to dry up the saliva prophylactically (these medications have been shown to reduce the length of time it takes leaks to seal). Any technique that can reduce leak rates in oesophageal atresia is to be welcomed. Additionally ICG may artifactually affect both peripheral oxygen readings (cause a transient decrease) and cerebral near infrared spectroscopy (NIRS) values (cause a transient increase). This is due to the temporary, dose dependent, interference of the dye with the mechanism of action of the monitoring rather than a physiological effect on oxygen levels. To date there has been no study investigating the effects of ICG on oxygen saturation and cerebral NIRS in neonates undergoing OA and/or dTOF repair. The theory is an extension from adult practice following oesophagectomy for cancer where there was a reduction in anastomotic leaks when using ICG/NIRF perfusion assessment. Another study in bariatric surgery using an enteral ICG/NIRF assessment was highly sensitive for anastomotic leaks allowing management of them intra-operatively. Objectives are to 1. Identify if the appearances of ICG/NIRF can predict anastomotic leaks 2. Identify if the ICG/NIRF images would engender a change in operative management leading to a reduced leak rate 3. Give a detailed report on the effects of ICG on oxygen readings This would be a cohort pilot study of 20 patients with the aim of informing a subsequent multi-centre Randomised controlled trial
Pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. Atrio-oesophageal fistula (AOF) represents a rare but devastating complication of AF ablation procedure. This complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. A worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.
Background and Objectives: Maintaining oxygenation during neonatal open repair of esophageal atresia is difficult. Inverse ratio ventilation can be used during one lung ventilation (OLV) to improve the oxygenation and lung mechanics. The investigators will compare inverse ratio to conventional ratio ventilation during OLV in neonatal open repair of esophageal atresia regarding effect in oxygenation, hemodynamic variables, incidence of complications, and easiness of procedure. Methods: The investigators will enroll 40 term neonates undergoing open right thoracotomy for esophageal atresia repair in this prospective randomized study. The patients will be randomly assigned into 2 groups based on inspiratory to expiratory (I:E) ratio of mechanical ventilation parameters (I:E ratio will be 2:1 in IRV and 1:2 in CRV). The incidence of desaturation episodes that needs to stop the procedure and reinflation of the lung will recorded as the primary outcome while hemodynamic parameters, incidence of complications, and length of surgical procedure will be recorded as the secondary outcomes.
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In a recent study, it was shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before knowing if this type of probe is more effective in protecting the oesophagus. The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.
The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.