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Fistula clinical trials

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NCT ID: NCT05725590 Recruiting - Pancreatic Fistula Clinical Trials

A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy

Start date: February 2, 2023
Phase: N/A
Study type: Interventional

The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.

NCT ID: NCT05721794 Recruiting - Crohn Disease Clinical Trials

Comparative Accuracy of Transperineal Ultrasound (TPUS) Versus Magnetic Resonance Imaging (MRI) for the Assessment of Perianal Fistulae in Patients With Crohn's Disease (CD): a Prospective Observational Longitudinal Cohort Study

TPUS-MRI
Start date: July 18, 2022
Phase:
Study type: Observational [Patient Registry]

Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) that may affect any site of the gastrointestinal tract, most frequently the ileum and colon. It is characterized by transmural inflammation and it can lead to strictures, due to activation of reparation of inflamed tissues and consequent fibrosis, or penetrating lesions, such as fistulas, between two different intestinal tracts or between intestine and surrounding organs. Fistula occurrence can lead to formation of abdominal or pelvic abscesses. Such complications cause intestinal damage and usually require surgery, leading to disability, impairment of patients' quality of life, with significant impact on direct and indirect health-care costs

NCT ID: NCT05668260 Recruiting - Clinical trials for Pancreatoduodenectomy

Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

BioSteP
Start date: January 25, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). Patients undergoing PD will be randomized into two arms: - arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis - arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis The rate of occurrence of CR-POPF will be compared between the two arms.

NCT ID: NCT05667272 Recruiting - Clinical trials for Postoperative Pancreatic Fistula

A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy

Start date: February 1, 2023
Phase:
Study type: Observational

To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

NCT ID: NCT05666609 Recruiting - Fistula in Ano Clinical Trials

Fistula-in-ano in Infants and Children

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.

NCT ID: NCT05641844 Recruiting - Anal Fistula Clinical Trials

A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract.

NCT ID: NCT05641233 Recruiting - Pancreatic Fistula Clinical Trials

Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

FIBROPANC-1
Start date: December 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.

NCT ID: NCT05638139 Recruiting - Anal Fistula Clinical Trials

Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

Start date: June 27, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.

NCT ID: NCT05616104 Recruiting - Clinical trials for Arterial Occlusive Diseases

FLEX FIRST Registry Research Protocol

Start date: November 29, 2022
Phase:
Study type: Observational [Patient Registry]

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

NCT ID: NCT05556915 Recruiting - Clinical trials for Arteriovenous Fistula Cannulation

Benefit of Ultrasound Guidance in Arteriovenous Fistula (AVF) Cannulation in Pediatric Hemodialysis

PafusGuC
Start date: December 3, 2022
Phase: N/A
Study type: Interventional

The arteriovenous fistula (AVF) is the reference hemodialysis vascular access for both adult and pediatric patients. The cannulation quality is decisive for the quality of the dialysis. Difficult AVF cannulations are more frequent in pediatrics than in adults. Recent studies in adults have shown that ultrasound-guided AVF cannulation improves the cannulation quality and therefore the quality of dialysis. This study aims to prove that ultrasound-guided AVF cannulation in children will improve the quality of dialysis overall.