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Fistula clinical trials

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NCT ID: NCT02111655 Completed - Thrombosis Clinical Trials

Improving Arteriovenous Fistula Patency

METTRO
Start date: September 1, 2012
Phase: N/A
Study type: Interventional

All vascular access guidelines recommend monitoring and surveillance protocols to prevent vascular access complications in hemodialysis units. However, in the case of second generation screening techniques which determine access blood flow measurement (QA), there is a huge controversy about it´s efficiency. Although multiple observational studies find a decrease in the thrombosis rate and an increased primary assisted patency survival related to the use of these techniques, a recently published meta-analysis find contradictory results in the randomized controlled trials, affirming that the measurement of QA is useless in grafts and questionable in native arteriovenous fistulae (AVF). We have designed a multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods. The primary endpoint will be a reduction in the thrombosis rate with an increased assisted primary patency survival, and a cost effectiveness economic analysis. As secondary endpoints we will analyze the impact over non-assisted primary patency survival and secondary patency survival.

NCT ID: NCT02110901 Completed - Clinical trials for Chronic Kidney Disease

A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

NCT ID: NCT02106962 Completed - Clinical trials for Arteriovenous Fistula

Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

Start date: April 2014
Phase: Phase 4
Study type: Interventional

This study will investigate how the use of Tranexamic acid and Bacitracin applied to the bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and Infection Rate

NCT ID: NCT02085486 Withdrawn - Dialysis Clinical Trials

Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients

Start date: August 2017
Phase: N/A
Study type: Interventional

The puncture of the vascular access in hemodialysis patients remains challenging even in the hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor patient satisfaction. The use of ultrasound by emergency department nurses and technicians without prior ultrasound experience in patients with difficult intravenous access showed in several studies to be very efficient. The investigators expect to achieve similar results in cannulation of AV shunts by the dialysis nurse staff after a short learning program. To show this, the investigators aim to conduct a trail where standard cannulation technique (inspection, palpation) will be compared with the ultrasound-assisted method in terms of efficacy, safety and patient satisfaction.

NCT ID: NCT02040454 Withdrawn - Clinical trials for Arteriovenous Access Fistula Stenosis

Paclitaxel for the Treatment of Distal Radial Artery Arteriovenous Access Fistula Stenosis (PaciFIST-2)

PaciFIST-2
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the use of intravascular paclitaxel, in addition to standard therapy, for the treatment of arteriovenous dialysis access fistula stenosis. A fistulogram will be performed in standard fashion. The diagnostic component will include evaluation of the inflow artery, arterial anastomosis and full length of the fistula vein or graft, plus venous return up to the heart. The location, vessel size, lesion diameter and percent stenosis for each lesion will be recorded. Enrollment and randomization will occur at this point. All patients will then receive standard therapy for their stenosis. This will include intravenous heparin administered in a standard dose of 70 units/kg. Lesions that respond poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations) will be stented. Stent selection will be based on clinical setting. Initial stent treatment will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard). Documentation of location and type of treatment for each lesion treated will be recorded. Once standard treatment is completed, the operating surgeon will be informed of the results of randomization: treatment (paclitaxel) or control. For subjects assigned to treatment, the whole fistula vein outflow segment of the fistula will be treated with paclitaxel. The full length of the radial artery from 1 cm of its origin to fistula anatomosis will be treated with paclitaxel. In addition the anastomosis and first 4 cm of the fistula vein will be treated. Paclitaxel solution treatment of each lesion encountered will be attempted until the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter and length of the vessels treated. Maximization of the length of vessel and lesions treated will be undertaken when there are more lesions than can be accommodated by the 12 mg, 10 ml dose available. A 5 F sheath, 20 cm in length, will be used to administer the paclitaxel. This will be advanced from its distal position in the radial artery over the guidewire so that the tip of the sheath is in the proximal radial artery. Prior to removal of the sheath, a final angiographic study of all areas treated is performed to document patency and lesion appearance. Any additional lesions identified with this study are then treated appropriately following standard technique. For the control group, instead of paclitaxel administration, a sham treatment period of 10 minutes is allowed to elapse followed by the performance of the final completion angiogram. Any additional lesions identified with this study are then treated appropriately following standard technique. All patients will follow the same follow up evaluation schedule

NCT ID: NCT02038504 Completed - Clinical trials for Gastrointestinal Fistula

Investigating the Role of EN in NTIS Among Fistula Patients

EN;NTIS
Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

NCT ID: NCT02033772 Completed - Clinical trials for Congenital Diaphragmatic Hernia

Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery

Start date: August 2013
Phase: N/A
Study type: Observational

The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.

NCT ID: NCT01997645 Recruiting - Anal Fistula Clinical Trials

Surgical Treatment of High Perianal Fistulas

LIFTRAF
Start date: November 2013
Phase: N/A
Study type: Interventional

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously. Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review. Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%). The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.

NCT ID: NCT01990833 Completed - Clinical trials for Enterocutaneous Fistulas

Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

Start date: January 2012
Phase: N/A
Study type: Observational

For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.

NCT ID: NCT01954225 Completed - Fistula in Ano Clinical Trials

Role of Udumbara Sutra in the Management of Fistula in Ano a Rare Case Study

Bhagandara
Start date: February 2006
Phase: N/A
Study type: Interventional

The anal fistula is a notorious disease due to its recurrence rate. Bhagandara is varyingly defined as a tear, ulcer or boil at Bhaga (Perianal region) within 2 finger circumference of it, causing painful abscess when opened is called Bhagandara. The Sanskrit word 'Bhagandara' has got two components-Bhaga and Darana. Bhaga means perianal region and Darana means to tear. The ancient Surgeon Sushruta has advocated various types of operations in Sushruta Samhita. He has advocated Kshara Sutra treatment due to probability of recurrence after surgery. Sushruta describes many kind of kshara like Palasa, Kadali. The most remarkable is Udumbara( Ficus Glomerata) among them. The present treatment modality Udumbara Kshara Sutra has been found effective due to its action of proper drainage of pus from the fistula that leads to a proper healing and as adjuvant therapy by avoid recurrence in Fistula in ano. Hypothesis; Present treatment modality Udumber Sutra will found to be useful in tne management of Fistula in ano.