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Fistula clinical trials

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NCT ID: NCT02364843 Terminated - Clinical trials for Diaphragmatic Hernia

A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months

INFORALTHR
Start date: February 2016
Phase: N/A
Study type: Interventional

This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed by parenterally (intravenously). Due to the new requirements of Health Canada for preparation of parenteral solutions, the investigators are starting the phase of the study that determines the enteral (oral) intake of threonine in 1 - 6 mo infants in the interim.

NCT ID: NCT02363972 Completed - Clinical trials for End Stage Renal Disease

Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Start date: February 10, 2015
Phase: N/A
Study type: Interventional

A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.

NCT ID: NCT02343302 Terminated - Pancreatic Fistula Clinical Trials

Prospective Trial Evaluating the Effect of Closed Suction Drainage Versus Straight Drainage After Distal Pancreatectomy

Start date: February 2013
Phase: N/A
Study type: Interventional

A very common complication following distal pancreatectomy is leakage from the pancreas, or what is called a pancreatic fistula. We hypothesize that operative drains which create suction may contribute to the development of leakage from the pancreas. This study evaluates the effect of using non-suctioning drains to prevent the development of this complication.

NCT ID: NCT02336867 Recruiting - Clinical trials for Complex Anal Fistula

Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial

FISCLOSE
Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common and generally associated with pain, anal incontinence, impaired quality of life and work incapacity. The therapeutic management of this disease has a double objective: heal the suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000 in the normal population, with a difference in prevalence between men and women (1.23 per 10 000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et al., 2012). In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses' anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an abscess between the internal and external sphincters, which in turn can spread to other parts of the perianal region. The infection can follow many directions from this point in the intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula therefore has always an intraductal origin, cryptic, with a primary port at this level, and the disregard of which causes the recurrence of the fistula; and usually a secondary port in the skin. Fistulas are usually divided into two groups. The first group contains fistulas called "simple", which are intersphincteric fistulas or trans-sphincteric involving only the lower third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group contains fistulas called "complex". These are intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric fistulas. For many years, the treatment of choice was to open the fistula (fistulotomy), but this procedure was associated with a risk of incontinence, the consequences could be potentially devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and advancement flap technique to cover internal opening of the fistula. The success of these therapies remains variable. The advancement flap technique remains a strategy of choice in the treatment of anal fistulas and particularly in the case of complex fistulas. The success rate of the advancement flap technique remains variable across studies but a recent meta-analysis finds a success rate of around 60%. A new technique for closing anal fistula is currently in development with the use of a closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners). This new technique has been validated in a porcine model of anal fistula, ensuring the safety of the device. A first case was published in a patient with complex anal fistula (high trans-sphincteric). After erosion fistula tract with a special brush, a nitinol clip (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight months after surgery, the fistula was healed and the clip was removed by cutting with special pliers. This technique is currently being broadcast and dozens of patients were treated with this clip without any further scientific validation of the process. To date, this innovative technique of the closure clip has not yet been assessed in a randomized controlled trial. It is therefore essential to carry out a prospective evaluation in order to determine the effectiveness and safety of this new device in the case of complex anal fistulas.

NCT ID: NCT02335099 Completed - Clinical trials for End Stage Renal Disease

Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited. The following data will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access 5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets, digoxin, statins). Patients will be randomized into two groups to receive: Group 1: Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.

NCT ID: NCT02331030 Completed - Clinical trials for Kidney Failure, Chronic

A Randomised Trial Comparing Supraclavicular Block vs Supraclavicular and Pecs II Block in Arteriovenous Grafting

Start date: December 2014
Phase: N/A
Study type: Interventional

This study evaluates the addition of Pecs II block to ultrasound-guided supraclavicular brachial plexus block in patients undergoing arteriovenous graft creation surgery. Participants will be randomised into two equal groups, one receiving supraclavicular and pecs II blocks, the other receiving supraclavicular block and sham block (Grade 1).

NCT ID: NCT02313597 Completed - Post Operative Pain Clinical Trials

Video-assisted Anal Fistula Treatment Versus Seton in the Management of High Peri Anal Fistula

Start date: August 1, 2014
Phase: N/A
Study type: Interventional

Anal fistula is the most common Peri anal disease. It's a disease with an incidence of 9 in 100,000. Anal fistula is classified on the basis of its location into high and low anal fistula, above or below dentate line respectively. Multiple series have shown that the formation of a fistula tract following anorectal abscess occurs in 7-40% of cases. There are typically 8-10 anal crypt glands at the level of the dentate line in the anal canal arranged circumstantially. These glands afford a path for infecting organisms to reach the intramuscular spaces. The cryptoglandular hypothesis states that an infection begins in the anal canal glands and progresses into the muscular wall of the anal sphincters to cause an anorectal abscess. According to internal opening many author proposed certain classification but the standardized in all of them is Park's classification, so this study categorized the patient through this classification. There are four types of fistula-in-ano in Park's Classification intersphincteric (between internal and external sphincters is 70%), transsphincteric (across external sphincters is 25%), suprasphincteric (over sphincters), and extrasphincteric(above and through levator ani).High anal fistula is considered to be difficult to treat because of its location.This study diagnosed the internal opening of high perianal with the help of endoluminal ultrasound and MRI. Classic method of its treatment are fistulotomy, fistulectomy and Setone placement but these are associated with lots of complication like fecal incontinence,recurrence,pain.Therefore many method have been recently devised including Ligation of intersphincteric fistula tract (Lift), glue repair and flap advancement.Another recently introduced method for its treatment is Video-assisted anal fistula treatment (VAAFT) proposed by P. Meinero which has been associated with less complications.

NCT ID: NCT02306382 Recruiting - Incontinence Clinical Trials

Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Start date: December 2012
Phase: N/A
Study type: Interventional

Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence. Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal. The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.

NCT ID: NCT02305992 Withdrawn - Clinical trials for Arteriovenous Fistula

Regional Anesthesia for Arteriovenous Fistula

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

Once kidney function goes below 10 to 15 percent of normal, dialysis treatments or a kidney transplant are necessary to sustain life. One type of dialysis is hemodialysis which cleans blood by removing it from the body and passing it through a dialyzer, or artificial kidney. To maximize the amount of blood cleansed during hemodialysis treatments, there should be continuous high volumes of blood flow. A fistula used for hemodialysis is a direct connection of an artery to a vein. Once an arteriovenous fistula (AVF) is created it is a natural part of the body. This is the preferred type of access because once the fistula properly matures and gets bigger and stronger; it provides an access with good blood flow that can last for decades. After the fistula is surgically created, it can take weeks to months before the fistula matures and is ready to be used for hemodialysis. There have been surgical factors identified; one of them being the anesthetic used which may cause a fistula not to survive. This study will look at comparing 3 anesthetic techniques: axillary block (AB) versus stellate ganglion (SGB) block+local anesthetic versus local anesthetic (LA).

NCT ID: NCT02297451 Completed - Clinical trials for Renal Failure, End-Stage

Trial Comparing the Incidence of Steal Syndrome in the Two Types of anTEcubitaL Fossa Arteriovenous fistuLa AVF

STEAL
Start date: February 2011
Phase: N/A
Study type: Interventional

Background: Arteriovenous fistula (AVF) is a form of vascular access for haemodialysis. An AVF is normally created at the level of the wrist, but occasionally it is created in the elbow when there is no suitable vessel in the forearm. The most common type of elbow (antecubital) fistula (AFF) is a brachiocephalic fistula, which carries significantly higher risk of steal syndrome (AVF-associated hand ischaemia) than wrist fistulas. More recently, AFF using proximal radial or ulnar artery as inflow has been described and shown to have a lower rate of Steal syndrome than brachiocephalic fistula. This study aims to investigate the incidence of steal syndrome between AFF using brachial artery and that using the proximal radial/ulnar artery as inflow.