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Fistula clinical trials

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NCT ID: NCT03643614 Completed - Clinical trials for Rectovaginal Fistula

Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula

Start date: August 1, 2017
Phase: Phase 1
Study type: Interventional

A new strategy for treatment of late radiation damage is to develop methods aimed at stimulating the regenerative capabilities of irradiated tissues. Since the main pathogenetic mechanism of the development of late radiation damage is the death or damage of the replicative mechanism of stromal cells (SC), a justified approach can be considered as transplantation of intact SC. Currently, there is convincing evidence in the scientific literature that the injection of intact autologous SCs into the zone of fibrosis surrounding the chronic radiation ulcer leads to the healing of a wound defect. An Initiative Clinical Trial. Introduction of autologous regenerative cells of adipose tissue for the treatment of post-irradiation vaginal-rectal fistula. It is assumed that patients will be included in the project within 12 months; the monitoring of each patient will last for 6 months; the total duration of the clinical part of the study will be 18 months; The total duration of the clinical trial including the preparatory phase and the writing of the report is about 24 months. It is assumed that at least 16 patients aged 20 to 75 years who have verified diagnosis of post-irradiation vaginal-rectal fistula will participate in this pilot project. The aims of the clinical trial are to preliminarily assess the safety, effectiveness and quality of life of patients after introducing autologous regenerative cells of adipose tissue for the treatment of post-irradiation vaginal-rectal fistula.

NCT ID: NCT03643198 Recruiting - Anal Fistula Clinical Trials

Oral Antibiotics for Anal Abscess

OFF
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

BACKGROUND Anal abscess and perianal fistula is a high prevalence disorder in general population that affect adult patients on young ages, affecting them significantly their social and quality of life. There is clinical evidence that the origin of most perianal fistulas (60%) is with an episode one year before of a perianal abscess. In fact, the established cryptoglandular hypothesis considered the origin of anal fistula, a chronic infectious disease starting on a clinical episode of an anal glands abscess. However, controversy exists regarding the role of antibiotics in the development of anal fistula after incision and drainage of perianal abscess. Nowadays, only two single-centre randomized controlled trials has been published addressing this issue, with inconclusive results. The MAIN OBJECTIVE of the study is to examine the clinical benefit of antibiotic therapy in patients with a perianal abscess, to avoid the development of a perianal fistula. METHODOLOGY We designed a prospective, multicentre double-blind placebo trial to analyse the clinical benefit of a course of antibiotics after perianal abscess drainage to diminish the probability of development of perianal fistula in the follow up of patients. Patients with anal abscess will be allocated randomly either to receive 7 days of oral metronidazole/ciprofloxacin in addition to their standard care or to receive standard care and placebo, after they will be discharged from the hospital. Patients will be followed clinically at different intervals during one year in order to know if they develop anal fistula. Also a quality of life assessment at the end of the study will be evaluated. EXPECTED RESULTS We expected that patients allocated to antibiotic treatment would develop a significant less anal fistulas in their follow-up with a related significant better quality of life. Thus, a change on standard of care led by our group, may be achieved.

NCT ID: NCT03636997 Completed - Anal Fistula Clinical Trials

Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula

NCT ID: NCT03633435 Recruiting - Nurse's Role Clinical Trials

Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation

DIADIDEAL
Start date: March 21, 2019
Phase: N/A
Study type: Interventional

Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

NCT ID: NCT03631173 Active, not recruiting - Pancreatic Cancer Clinical Trials

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy

MINIMUM
Start date: April 2, 2019
Phase: N/A
Study type: Interventional

A pancreaticoduodenectomy is performed in patient with pancreatic cancer. The most common and serious complication is leakage between the intestine and the remnant pancreas after this procedure. It occurs in 20-30%. The result is often prolonged hospital and ICU stay, reoperations and deaths (3-5%). To detect a leakage early before the patient becomes seriously ill, thereby initiating treatment is therefore very important. By inserting a thin microdialysis catheter near the anastomosis between pancreas and intestine before closure of the abdominal wall, the investigators will analyze substances such as lactic acid, pyruvate, glycerol, etc. and if these substances may reveal anastomosis leakage at an early stage. Observational studies have shown that if a leakage occurs, glycerol concentration in the microdialysate will rise significant after few hours, and changes in lactic acid and pyruvate values will change as a sign of inflammation. The investigators want to conduct a randomized study comparing patients undergoing pancreaticoduodenectomy and using microdialysis in half of the included population.

NCT ID: NCT03627559 Completed - Pancreatic Cancer Clinical Trials

Early Detection of Anastomotic Leakage by Microdialysis Catheters

Start date: October 1, 2013
Phase:
Study type: Observational

Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. This observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

NCT ID: NCT03600584 Not yet recruiting - Pancreatic Fistula Clinical Trials

Modified Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy

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

The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy

NCT ID: NCT03595839 Completed - Anal Fistula Clinical Trials

Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

NCT ID: NCT03566927 Terminated - Clinical trials for Arteriovenous Fistula

FLEX®-DCB Dialysis ACCESS Stenosis Study

AVAFLEX
Start date: May 29, 2018
Phase: N/A
Study type: Interventional

This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.

NCT ID: NCT03555773 Completed - Crohn Disease Clinical Trials

Micro-fragmented Adipose Tissue and Complex Crohns' Anal Fistulas

Start date: May 11, 2016
Phase: N/A
Study type: Interventional

The study aims to evaluate safety, feasibility and effectiveness of local injections of autologous and micro-fragmented adipose tissue obtained with the Lipogems® system in patients with refractory complex fistulizing perianal Crohn's disease.