Active clinical trials for "Fistula"

The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.

Background Arteriovenous (AV) fistula is the most common vascular access for long-term hemodialysis in the end-stage renal disease (ESRD) patients. About 25% of these patients are diabetes mellitus. However, the effects of hyperglycemia on the vascular function of arteriovenous fistula are still remained unclear. Studies have shown that blood flow in the AV fistula is significantly reduced in patients with diabetes mellitus. Diabetic patients also require a longer period of time for the maturation of AV fistula, and have slightly higher complication rate than non-diabetic patients. Statins have been widely shown to mediate several important pleiotropic effects in the improvement of vascular endothelial dysfunction, attenuation of inflammatory responses, stabilization of atherosclerotic plaques, inhibition of vascular smooth muscle proliferation, and modulation of procoagulant activity and platelet function.Our experimental studies in diabetic animals demonstrate that administration of a water-soluble statin rosuvastatin significantly improves the fistula flow, vascular function and luminal dilatation of AV fistula in diabetic rats by suppression of vascular oxidative stress and inflammatory load. Study hypothesis The central hypothesis of this research project is rosuvastatin mediates pleiotropic protective effect on vascular endothelial function and suppresses the regional pro-inflammatory reaction in the vasculature, therefore administration of rosuvastatin during the perioperative period of creation of native AV fistulas in diabetic patients with ESRD may potentiate the vascular function and reduce the primary failure rate of AV fistulae.

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.

The perianal region is the region around the anus. Administering a pain medication before a surgery starts is called preemptive analgesia. In some studies, this technique has been shown to be an effective way to reduce the pain that a patient experiences in the post-operative timeframe to a greater extent than would be expected simply from the pain medications alone. One theory of why this occurs suggests that the preemptive analgesia desensitizes brain and nerves to pain, thereby decreasing the response to painful stimuli, like surgery when they occur. This leads to a decrease in the amount of narcotic pain medication required after the procedure, which leads to less side effects and a quicker return to normal functioning. As perianal surgeries do not usually include a long stay in the hospital, controlling post-procedure pain is a priority. The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well established, but as the perianal region has not been well studied, its use is not the standard of care. This type of analgesia uses a combination of medications that are already in use for post-operative and non-operative pain control and administers them orally prior to the patient undergoing general anesthesia. The side effects of the medications are the same as if they had been given after surgery or for non-surgical pain. The concept of preemptive analgesia is established in other types of surgeries and it has solid basic science to support its use. The purpose of this randomized, double-blind, placebo controlled study is to determine if patients undergoing perianal surgeries could benefit from preemptive pain control. The primary outcome will be whether patients experience less post-operative pain. Patient post-operative consumption and latency until use of narcotic pain medication will be the secondary outcomes. The investigators believe that the patients receiving pain medications before their operation will require less pain medication after surgery, with minimal increased risk to the patient.

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

Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.

The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.

.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .

Rationale: Perianal fistulas are a common incapacitating problem. Many patients are treated by seton drainage to prevent recurrent abscess formation. Nowadays, vessel loops or sutures are used for drainage. The knot of these seton drains can cause complaints of pain or tenderness if it presses against the external opening of the fistula or even slides in to the fistula tract. Medishield B.V. designed a knotless seton drain, the SuperSeton. This could decrease the pain complaints caused by the knot. Objective: The aim of this study is to determine the feasibility of SuperSeton placement in patients with perianal fistulas. Study design: The design of the study is a feasibility study. Study population: Patients (≥ 18 years) with perianal fistulas (ever) treated with a knotted seton are eligible. Intervention: The SuperSeton will be placed at the outpatient clinic in patients that already have a seton in situ. This seton will then be exchanged by the SuperSeton. In case patients do not have a seton in situ, the SuperSeton can be placed at the operating theatre in day care setting instead of a regular seton. Main study parameters/endpoints: The primary outcome is seton failure (loosening of the seton). Secondary outcomes are time of procedure, complications and quality of life measured by the PDAI ('Perianal Disease Activity Index'). Nature and extent of the burden and risks associated with participation: The SuperSeton will be placed in patients with perianal fistulas (ever) treated with a conventional knotted seton. There are no additional risks involved. The seton will be placed at the outpatient clinic in patients with a seton in situ, or at the operating theatre in day care setting in patients with a perianal abscess without a seton. The material that is used for the Setons is of medical grade polyurethane, this is the same material of catheters that are already used in clinical practice (instech BTPU 027). The Setons including the insert (BTPU) are supplied sterile (Synergy Health). Sample size calculation: A group of 60 patients will be included to determine feasibility of the SuperSeton. The proposed treatment protocol is considered feasible if at least 70% of the SuperSetons stay in place.

Pilonidal disease often presents as a chronic, relapsing condition. A variety of procedures are used in the management of pilonidal disease, with varying degrees of morbidity, disease-free interval, and long-term success. In patients with new-onset or recurrent pilonidal disease, the investigators aim to address how minimally invasive trephine excision compares to other surgical procedures in terms of short- and long-term clinical outcomes and patient satisfaction. In the absence of a gold standard surgical procedure, surgeon preference will help dictate the management of pilonidal disease. For many surgeons, this means a variation on open excision for pilonidal disease failing conservative management. However, outcomes for minimally invasive pilonidal excision (MIPE) as initially described by Gips and forthcoming Lipskar et al., are likely to alter management of the disease (Gips, 2008). The investigators wish to assess patient and surgeon satisfaction with MIPE, and short-term outcomes.