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Fistula clinical trials

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NCT ID: NCT04900012 Not yet recruiting - Clinical trials for Surgery--Complications

Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Spadispan
Start date: July 1, 2021
Phase:
Study type: Observational

Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

NCT ID: NCT04898517 Completed - Pancreas Disease Clinical Trials

Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).

CONDUCTJE-ST
Start date: January 1, 2018
Phase:
Study type: Observational

Objective: To assess the efficacy of the "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)" technique to prevent clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy (PD). Summary Background Data: CR-POPF remains the most determining cause of morbidity and mortality after PD. The incidence of CR-POPF (grades B and C, ISGPS) is around 20% and is a potential source of severe secondary complications that are associated with a mortality of up to 40%. Methods: A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique, the steps of which are described, performed by the same surgical team from January 2018 to February 2020. No patient received prophylactic or therapeutic somatostatin or its analogues. The primary endpoint was the incidence of CR-POPF. Secondary endpoints were postoperative mortality and morbidity, hospital course and during the first year of follow-up. In a prospective study we have evaluated a "novel" technique, modification of the preexisting ones, for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD, termed "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)", applicable to any type of pancreatic remnant, regardless of its texture and the diameter of the main pancreatic duct. The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF, so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD.

NCT ID: NCT04896476 Active, not recruiting - Kidney Diseases Clinical Trials

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.

NCT ID: NCT04879667 Completed - Clinical trials for Bariatric Surgery Candidate

Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy l

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. The study was approved by the research and Ethics committee of investigators' University .a written informed consent was obtained from all participating patients after explaining to them all the study procedures with its benefits and hazards. the work has been carried out in accordance with the code of ethics of the world medical association ( Declaration of Helsinki ) for studies involving humans .the sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of refractory gastro-cutaneous fistula by surgical intervention 50% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.

NCT ID: NCT04876976 Completed - Hypospadias Clinical Trials

Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

Start date: January 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair

NCT ID: NCT04876690 Completed - Crohn Disease Clinical Trials

A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

CONFLICT
Start date: July 9, 2021
Phase:
Study type: Observational

The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas in a standard clinic setting. Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.

NCT ID: NCT04847739 Recruiting - Crohn's Disease Clinical Trials

Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.

NCT ID: NCT04844593 Completed - Crohn Disease Clinical Trials

A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease

INTUITION-CPF
Start date: March 8, 2022
Phase:
Study type: Observational

Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical records.

NCT ID: NCT04834609 Completed - Perianal Fistula Clinical Trials

Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas

Start date: January 2015
Phase: N/A
Study type: Interventional

This study investigated the cellular and molecular characteristics of AT-MSCs obtained from autologous AT therapy in patients with high transphincteric perianal fistulas of crytoglandular origin. Adipose tissue was injected into anal fistulas. Characteristics of adipose tissue mesenchymal stemcells (AT-MSC) was investigated and compared in patients with fistula that healed after the treatment (responders) to patients who failed to heal (non-responders)

NCT ID: NCT04815954 Recruiting - Clinical trials for Urinary Tract Infections

Early vs Late Urinary Catheter Removal After Renal Transplantation

ELUCATR
Start date: March 26, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to compare frequency of UTI, urine leak and need for reoperation in patients after renal transplant with early or delayed Foley catheter removal. The hypothesis of the ELUCATR trial is that there is no need to keep Foley catheter longer than 24 hours after kidney transplant due to lack of significant effect on urological complications (urine leak, ureter strictures). Early removal can also reduce urinary tract infections. Main advantage of urinary catheter placement is continual diuresis monitoring and lower bladder pressure. Some hypothesize that increased pressure can disrupt ureteroneocystostomy with resultant urinary fistula. Clinical practice is to remove the catheter between 1-10 post-transplant day. Only few studies described removal of Foley catheter in the first 48 hours. There is no level 1 evidence for timing of urinary catheter removal after kidney transplantation. Urinary tract infection is a common complication after KTx occurring in about 7-80% patients. Studies suggest direct negative effect of UTI on long-term renal allograft function. There are several independent risk factors for developing UTI: female sex, diabetes and obesity. Duration of catheterization is a modifiable risk factor. Urine leak and ureter stenosis are relatively frequent surgical complications of kidney transplantation. Urine leaks occur in 2-9% of all kidney transplants. Most of them happen within 3 months after surgery. Urinary fistula contributes to mortality and graft loss. Majority of them need intervention with nephrostomy, pigtail ureteral stent or surgery. Anastomotic or ureter stenosis occurs in 3.1% of all kidney transplants and is usually resolved with open ureteroneocystostomy. Diagnosed and treated early, it does not affect patient and graft survival. There are no solid data documenting influence of the urinary bladder catheterization on fistulas, urinomas, ureter strictures and need for reoperation in this set of patients. European Best Renal Practice Guidelines recommend removal of the catheter as early as possible, however a randomized trial on timing and adverse event rates (urinary tract infection, urinary leakage) is needed.