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Fistula clinical trials

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NCT ID: NCT02848157 Completed - Hypospadias Clinical Trials

Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery

Start date: June 17, 2016
Phase: Phase 4
Study type: Interventional

Caudal block is often performed to relieve postoperative pain in pediatric urological surgery. Recently, pudendal block is also used in penile surgery and it has advantage because of less side effects such as transient weakness of low extremities, but limited to use in penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and potentiates the effect of local anesthetics. There are many studies about the potentiation of the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as adults.

NCT ID: NCT02814721 Completed - Clinical trials for Arteriovenous Fistula, Cannulation

Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique

Start date: March 2015
Phase: N/A
Study type: Interventional

Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.

NCT ID: NCT02807389 Completed - Clinical trials for Surgical Leak Fistula

Stem Cell Fistula Plug in Post Surgical Leak Fistulas

Start date: March 14, 2017
Phase: Phase 1
Study type: Interventional

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (The Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients (age 18 and greater) with persistent symptomatic post-surgical gastrointestinal leaks despite current standard radiologic and endoscopic therapies will be enrolled. The subjects will be subsequently followed for fistula response and closure for 18 months. This is an autologous product derived from the patient and used only for the same patient.

NCT ID: NCT02805595 Completed - Clinical trials for Hidradenitis Suppurativa

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Start date: August 2016
Phase: Phase 2
Study type: Interventional

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

NCT ID: NCT02790333 Completed - Clinical trials for Pancreatic Neoplasms

Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Start date: May 2016
Phase: N/A
Study type: Interventional

The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

NCT ID: NCT02784990 Completed - Pancreatic Fistula Clinical Trials

Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions

LIPA-DRAIN
Start date: June 3, 2016
Phase:
Study type: Observational

Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. It has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections. To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. However in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase with no clinical consequences. It is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs. In a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients. The objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery. The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of blood and a tube of drain liquid.

NCT ID: NCT02770352 Completed - HIV Clinical Trials

Fistula Formation and Successful Repair

Start date: October 2012
Phase:
Study type: Observational

The objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Data collection will be prospective starting in 2011 upon institutional review board (IRB) approval to last a minimum of five years and will have a retrospective component tracing back to January 2010. Primary goals of data analysis will be to determine the risk factors for fistula formation, risk factors for poor surgical outcomes and long-term incontinence, social and economic impact of fistula repair, and the ability of various physical exam findings to predict likelihood of successful repair. It is expected that findings will lead to improved surgical management of obstetric fistulas both locally and internationally.

NCT ID: NCT02768493 Completed - Clinical trials for Inguinal Hernioplasty

Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block

Start date: May 2016
Phase: N/A
Study type: Interventional

The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.

NCT ID: NCT02753998 Completed - Angioplasty Clinical Trials

Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula

ABISS
Start date: December 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this double-blind study is to compare the frequency of primary patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with paclitaxel). The other objectives of the study are: 1. To compare the frequency of primary patency at 3 months and 12 months. 2. To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12 months. 3. To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula deteriorating back to preoperative flow rate (within 20% of preoperative flow rate). 4. To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml / min. 5. To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis. 6. To compare, at 3, 6 and 12 months, the medical costs related to direct medical care, initial treatments, monitoring, diagnosis and treatments of complications.

NCT ID: NCT02746159 Completed - Clinical trials for Arteriovenous Fistula

Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

AVR
Start date: June 7, 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.