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Fistula clinical trials

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NCT ID: NCT03886116 Recruiting - Clinical trials for End Stage Renal Disease

Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow

Start date: November 28, 2018
Phase: N/A
Study type: Interventional

This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery. This is a randomised control study with 20 patients each in the Control arm (Group A) or the Exercise arm (Group B). The subjects will be randomised into 1:1 into one of the two groups. The patients will have an ultrasound doppler vein mapping done prior surgery and the necessary follow up visits.

NCT ID: NCT03880773 Recruiting - Pancreatic Fistula Clinical Trials

Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

TRUDY
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. There is no published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the reduction of POPF. The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US). This is a randomized controlled, multicenter, patient-blinded, superiority trial. This protocol was designed according to the SPIRIT guidelines. Two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as control. The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.

NCT ID: NCT03878498 Active, not recruiting - Crohn Disease Clinical Trials

Management of Anal Fistula of Crohn Disease

FISTUCROHN
Start date: June 19, 2018
Phase:
Study type: Observational

The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

NCT ID: NCT03865823 Recruiting - Anal Fistula Clinical Trials

Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

PROFIL
Start date: March 1, 2019
Phase:
Study type: Observational

Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist. The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment. The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.

NCT ID: NCT03864718 Completed - Rectal Fistula Clinical Trials

Photodynamic Therapy in Anal Fistula

Start date: January 2016
Phase:
Study type: Observational

Objective: Validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula. Methods: Prospective observational study including patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). Patients were included with a minimum follow up of 1-year, in order to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).

NCT ID: NCT03861689 Enrolling by invitation - Clinical trials for Inflammatory Bowel Diseases

Tight Control Management in Perianal Crohn's Disease

PLACE-PCD
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Perianal Crohn's disease (pCD) affects around one-third of patients with Crohn's disease (CD) during their disease course. It represents a distinct disease phenotype and causes significant morbidity, often requiring multiple surgical interventions. However, treatment of pCD is still challenging and unsatisfactory. Only approximately one-third of pCD patients responded to biologic treatment. Overall, medical therapy with anti-TNF could only achieve prolonged remission in 30-40% of pCD cases. At the same time, surgical treatment could only lead to a favourable outcome in around 50% of patients with a higher recurrence rate in patients with complex than in simple fistulae. Recently, combination of optimal medical therapy with surgical therapy (drainage of sepsis and insertion of seton), with radiological guidance, has been suggested as the standard management so as to improve the outcomes of complex pCD. Magnetic resonance imaging (MRI) is considered to be the gold standard imaging technique for perianal CD. It can visualise the anal sphincter and the pelvic floor muscles, as well as the fistula tracts and abscesses. Previous studies using MRI to monitor treatment response to anti-TNF revealed that radiological healing lagged behind clinical remission by a median of 12 months and that long-term maintenance therapy is probably required to prevent recurrence despite a clinically healed external opening. Therefore, we hypothesize that serial monitoring with MRI is important. Recently, there has been some advance in the surgical treatment of perianal Crohn's disease. FiLaCTM uses a radial-emitting disposable laser fibre for endofistular therapy. Recent systemic review and meta-analysis showed that the primary success rate was 73.3% (11/15) in patients with perianal Crohn's fistula. There has been breakthrough in the management of luminal Crohn's disease. The CALM study has showed that timely escalation of anti-TNF on the basis of clinical symptoms combined with biomarkers in patients with luminal Crohn's disease resulted in better clinical and endoscopic outcomes than symptom-driven decision alone. It is unsure whether this approach is also applicable to patients with perianal Crohn's disease.

NCT ID: NCT03853070 Recruiting - Aneurysm Clinical Trials

Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

Start date: December 11, 2018
Phase:
Study type: Observational

This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.

NCT ID: NCT03850236 Completed - Clinical trials for Pancreatoduodenectomy

Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

PaNECK
Start date: January 1, 2009
Phase:
Study type: Observational

Brief Summary:* Aim of the study : To evaluate if the neck division level significantly influences the postoperative pancreatic fistula rate of pancreatico-jejunal anastomosis after pancreatoduodenectomy. Methods : Patients who underwent oncologic or non-oncologic pancreatoduodenectomy between 01 January 2009 and 04 April 2018 will be included in this retrospective analysis. Two independent radiologists will measure the distance between the left side of the portal vein and the remnant pancreatic stump on post operative CT scan, blindly for postoperative course. This new variable will be integrated in a logistic regression model in addition to well known risk factors of POPF.

NCT ID: NCT03832959 Recruiting - Atrial Fibrillation Clinical Trials

Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study evaluates the benefit of using the EnsoETM, a device device for esophageal temperature adjustments, during catheter ablation of atrial fibrillation. Half of participants will undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the other half will undergo catheter ablation with no esophageal temperature adjustment.

NCT ID: NCT03830658 Completed - Hemodialysis Clinical Trials

Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients

SISC-AVF
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

End stage renal disease patients (ESRD) should be educated to take care of their arteriovenous fistula (AVF). Educational programs should have clear objectives and the interventions should be well defined. Therefore, assessing the interventions that can have the strongest impact on the patient's acquisition of self-care behaviors with AVF is extremely important. The aim is to assess the effectiveness of a structured intervention on the frequency of self-care behaviors with AVF by patients with ESRD on hemodialysis (HD).