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Fistula clinical trials

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NCT ID: NCT05735964 Not yet recruiting - Clinical trials for Tracheo-Esophageal Fistula With Atresia of Esophagus

Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula

iTOF
Start date: March 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05725967 Enrolling by invitation - Obesity Clinical Trials

Endoscopic Metabolic and Bariatric Therapies

EMBTs
Start date: July 8, 2022
Phase:
Study type: Observational [Patient Registry]

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

NCT ID: NCT05725590 Recruiting - Pancreatic Fistula Clinical Trials

A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy

Start date: February 2, 2023
Phase: N/A
Study type: Interventional

The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.

NCT ID: NCT05721794 Recruiting - Crohn Disease Clinical Trials

Comparative Accuracy of Transperineal Ultrasound (TPUS) Versus Magnetic Resonance Imaging (MRI) for the Assessment of Perianal Fistulae in Patients With Crohn's Disease (CD): a Prospective Observational Longitudinal Cohort Study

TPUS-MRI
Start date: July 18, 2022
Phase:
Study type: Observational [Patient Registry]

Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) that may affect any site of the gastrointestinal tract, most frequently the ileum and colon. It is characterized by transmural inflammation and it can lead to strictures, due to activation of reparation of inflamed tissues and consequent fibrosis, or penetrating lesions, such as fistulas, between two different intestinal tracts or between intestine and surrounding organs. Fistula occurrence can lead to formation of abdominal or pelvic abscesses. Such complications cause intestinal damage and usually require surgery, leading to disability, impairment of patients' quality of life, with significant impact on direct and indirect health-care costs

NCT ID: NCT05711433 Completed - Pancreas Neoplasm Clinical Trials

Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.

Start date: July 1, 2014
Phase:
Study type: Observational [Patient Registry]

Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

NCT ID: NCT05709717 Not yet recruiting - Perianal Fistula Clinical Trials

Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Start date: January 25, 2023
Phase:
Study type: Observational [Patient Registry]

Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median & interquartile range (IQR)

NCT ID: NCT05693584 Completed - Clinical trials for Hemodialysis Patients

The Effect of Using Virtual Reality Glasses on Pain During Fistula Cannulation in Hemodialysis Patients

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Hemodialysis; It is the process of returning the liquid and solute content of the blood taken from the patient to the patient as a result of rearrangement by means of a membrane and with the help of a machine. A permanent vascular access that can be used for months or years is required for HD treatment to be sufficient for patients with end-stage renal disease to survive and improve their quality of life. For this reason, patients who will be treated for HD need to have an arterio-venous fistula (AVF), graft or catheter to ensure adequate blood flow. CRF patients treated with HD are exposed to 300-320 AVF cannulations per year on average. The size and length of the diameter of the fistula needles, the piercing process created in the skin, the advancement of the needles into the tissue during the procedure, the entry angle of the needles and the entry techniques cause the patients to experience pain during the procedure. Non-pharmacological methods frequently used in pain control include many applications such as distraction, massage, hot and cold application, aromatherapy. Distraction, which is one of the non-pharmacological methods, is a method that enables patients to focus their attention on a different point and to control and reduce the symptoms they experience. Methods such as listening to music, taking pictures, watching television, solving puzzles, daydreaming, deep breathing and coughing exercises, sphygmomanometer blowing, active listening, tapping, inflating balloons, distraction cards and using virtual reality glasses are used for this purpose. With the virtual reality glasses, the individual gets away from the environment with the glasses connected to the device worn on his head and the sounds coming from the headset, concentrates his attention on the image he watches and feels like he is in another world thanks to these five-dimensional glasses. The most basic feature that distinguishes virtual reality glasses from similar applications is that it gives people a real feeling. Virtual reality glasses, which are easy to apply and use, have no side effects, and can be effective in physical, psychological and social recovery, are an initiative that can be preferred in health applications. In this study, it is aimed to determine the effect of using virtual reality glasses on pain during fistula cannulation applied to hemodialysis patients. The hypotheses of the research; Hâ‚€: The use of virtual reality glasses is not effective in reducing the severity of pain. H1: The use of virtual reality glasses reduces the severity of pain.

NCT ID: NCT05687825 Completed - Pancreatic Fistula Clinical Trials

Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

Start date: August 1, 2017
Phase:
Study type: Observational [Patient Registry]

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

NCT ID: NCT05686200 Enrolling by invitation - Clinical trials for Arteriovenous Fistula

The Effect of Intelligent Exercise on Vascular Function, Grip Strength and Adherence in Patients With AVF After Surgery

Start date: March 2023
Phase: N/A
Study type: Interventional

Isometric exercise can effectively promote the vascular function of arteriovenous fistula and increase hand grip strength, but patients needs to perform isometric exercises patiently. The purpose of this study want investigate the effect of using individual intelligent devices for forearm isometric exercise training on the increase of arteriovenous fistula vascular function and hand grip strength, and the improvement of patients' adherence with forearm isometric exercise.

NCT ID: NCT05682768 Completed - Pancreatic Fistula Clinical Trials

Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure

Start date: January 1, 2018
Phase:
Study type: Observational

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.