Active clinical trials for "Fistula"

Restorative proctocolectomy with ileal pouch anal anastomosis (IPAA) is the procedure of choice for patients with ulcerative colitis, familial adenomatous polyposis, and select patients with Crohn's disease due to overall low patient morbidity and good quality of life. However, some patients can develop Crohn's disease of the pouch, a clinical diagnosis of Crohn's disease following IPAA. One of the manifestations of Crohn's disease of the pouch includes a fistula from the pouch that travels to the vagina or perianal area. These fistulas can be quite difficult to manage with medications and local surgical intervention, and, on occasion result in a reconstruction pouch but more often require a pouch excision with permanent end ileostomy. The purpose of this study is to evaluate the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells to treat people who have a peri-pouch fistula related to a clinical diagnosis of Crohn's disease of the pouch.

To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.

Feasibility of the Vessel Restoration System for AVF

Benign airway stenosis and respiratory tract fistula are common types of airway injury. The diseases occurred after endogenous and exogenous stimuli (tuberculosis, tumor, surgery, tracheal intubation) causing damage to the airway mucosa, resulting in scar repair and irreversible loss of airway epithelium. Autologous adipose vascular fraction (stromal vascular fraction, SVF) is a mixture of cells obtained from adipose tissue through digestion and centrifugation, containing a variety of cell types, such as mesenchymal cells, endothelial progenitor cells, endothelial cells, pericytes, and macrophages. Previous studies have shown that SVF can achieve regeneration and wound healing through modulating the immune microenvironment, promoting angiogenesis, thereby promoting endogenous regeneration of the in situ adult stem cells. This project utilizes the tissue repair function of autologous SVF to treat benign airway stenosis and respiratory tract fistula. To clarify the efficacy and safety of autologous SVF in the treatment of airway injury.

Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA. Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate but a poor 1-year patency rate. These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital. Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty. For the past few years, angioplasty balloons delivering anticancer drugs have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer molecule through the different layers of the vessel wall confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy. These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty. These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising. The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered. Patients that will be non-evaluable for the primary endpointwill be censored at the date of the latest news.

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. The use of palatal flaps has been documented for treating such fistulae. The presence of the oroantral fistula at the area of second molars or maxillary tuberosity could complicate the use of the palatal rotational flap where the arch of its rotation is increased leading to compromised blood supply. The use of the buccal flap is not advocated because it is very thin. Rationale Double or triple-layer closure is indicated to avoid recurrence of the COAF. Different layers have been documented to minimize the risk of recurrence and reinforce buccal flaps. The oral tissues at the oral side of the oroantral fistula could used as an additional layer with buccal advancement flap and buccal fat to omit the use of palatal flap with its subsequent problems in the most posterior aspect of the maxilla Study objectives Therefore, this study will be conducted to evaluate the use of hinge flaps to reinforce the buccal advancement flap for surgical closure of the COAF in the most posterior area of the maxilla Methods The hinge flap will be performed at the oral side of the COAF to close the perforation in the sinus membrane. The oral side of the COAF will be closed with buccal advancement flap. The success rate, recurrence, time of surgery, postoperative complications, will be evaluated.

The aim of this study was to reduce the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy by using different pancreaticojejunostomy methods according to the position of the pancreatic duct.

Rationale: Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\ Objective: The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas. Study design: The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality. Study population: Men and women of 18 years and older who present for the first time with a perianal abscess. Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets. Main study parameters/endpoints: Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.