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Fistula clinical trials

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NCT ID: NCT04577456 Recruiting - Ileostomy - Stoma Clinical Trials

Chyme Reinfusion for Type 2 Intestinal Failure

REINFUSE
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas. The device system functions simply to return the output from a fistula back into the distal limb of the intestine.

NCT ID: NCT04571541 Recruiting - Clinical trials for Esophageal Perforation

Endoscopic Management of Esophageal Wall Defects

Start date: July 1, 2014
Phase:
Study type: Observational

The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.

NCT ID: NCT04549311 Active, not recruiting - Perianal Fistula Clinical Trials

Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial

PARFAIT
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

Most perianal abscesses (PA) result from an infection originating in anal crypts that extend into anal glands in the intersphincteric plane. Patients commonly present to the ER and usually require surgical intervention, which poses a burden on the healthcare system. If left undrained, a PA can expand into the adjacent tissues as well as progress to systemic infection. One of the major complications of PA are perianal fistulae; the creation of a tract between the anal canal and the perianal skin that is lined with granulation tissue or skin cells. Up to 1/3 of patients with a PA will develop a fistula; which occurs if a PA drains spontaneously through the perianal skin, and the infection becomes chronic. If this happens, surgical intervention is needed and abscesses may reoccur. Post incision and drainage (I&D) antibiotics in PA have been used to address complications but their use is still controversial and there are no specific recommendations on their use to prevent the formations of fistulae. Recent findings from a systematic review (6 studies, N=817 patients) published in 2019 demonstrated that antibiotic use following I&D of PA was associated with a 36% lower odds of fistula formation, though the quality of the evidence was low. As there are no established prophylactic treatments for fistulae, and because they are difficult to treat, further study of this simple intervention seems warranted. In this trial, adults with a PA requiring I&D will be randomly assigned to receive standard of care with antibiotics or standard of care without antibiotics after I&D. This trial will be conducted under the IMPACTS (Innovative, Multicentre, Patient-centred Approach to Clinical Trials in Surgery) program umbrella and will follow IMPACTS methodology. For the Vanguard trial, the aim is to determine the feasibility of conducting a definitive trial. Future outcomes of interest are incidence of fistula formation (defined as drainage of the perianal region at or after 2 months), need for re-intervention (i.e., any intervention on the perianal region), quality of life, healthcare utilization, healing time and mortality.

NCT ID: NCT04543539 Recruiting - Clinical trials for Arteriovenous Fistula

IN.PACTâ„¢ AV Access Post-Approval Study (PAS002)

Start date: November 13, 2020
Phase:
Study type: Observational [Patient Registry]

Long-term safety will be summarized

NCT ID: NCT04541238 Not yet recruiting - Anal Fistula Clinical Trials

Imaging Template for Reporting Anal Fistula

ITRAF
Start date: September 1, 2020
Phase:
Study type: Observational

Magnetic resonance imaging (MRI) is the most used diagnostic tool for pre-operative assessment of anal fistula. However, there is lack of standardization in reporting this investigation. Moreover, reports may miss a number of key information for surgical planning. The aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.

NCT ID: NCT04519697 Recruiting - Crohn Disease Clinical Trials

Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease

RVF
Start date: October 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Approximately 10% of all female Crohn's patients have a rectovaginal fistula. Rectovaginal fistulas cause air, stool, and/or drainage per vagina and may be associated with pain, recurrent urinary tract infections and diminished quality of life. Conventional therapy includes immunosuppressive medications used to treat Crohn's disease and various surgical interventions. However, all have limited ability to heal these fistulas. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with rectovaginal fistulas in the setting of Crohn's disease.

NCT ID: NCT04519684 Recruiting - Crohn Disease Clinical Trials

Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's Disease

IPAAF
Start date: October 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT04519671 Recruiting - Crohn Disease Clinical Trials

Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease

PFCD
Start date: November 19, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of using adult allogeneic bone marrow derived mesenchymal stem cells (MSCs), to treat people for medically refractory perianal fistulizing Crohn's disease.

NCT ID: NCT04514198 Completed - Pancreas Disease Clinical Trials

Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy

Start date: March 1, 2020
Phase:
Study type: Observational

AIM To determine association between postoperative pancreatitis and pancreatic fistula OBJECTIVES 1. To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy 2. To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula 3. To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula Primaryendpoint: Incidence of post operative pancreatitis and post operative pancreatic fistula. Secondaryendpoints: 1. to identify the possible predictors of post operative pancreatitis. 2. to investigate the association between post operative pancreatitis and post operative pancreatic fistula. MATERIAL AND METHODS Study centre: Inpatient admissions in Department of gastroenterology, Asian institute of gastroenterology, Hyderabad Study population: Patients who are supposed to undergo pancreaticoduodenectomy Study design: Prospective observational study Study period: Study will be conducted till desired sample size achieved or March 2020 to march 2022

NCT ID: NCT04508374 Recruiting - Clinical trials for Hidradenitis Suppurativa

Intralesional Diode Laser Treatment of Fistulas in Hidradenitis Suppurativa

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Hidradenitis suppurativa (HS) is a common chronic skin disease where patients experience inflamed painful nodules and chronic suppurating tunnels under the skin that often leave mutilating scars. Symptoms typically begin during adolescence and patients struggle with pain, pruritus, malodor and purulent discharge compromising work life, physical exercise, and sexual habits. Consequently, the risk of social exclusion, anxiety, depression, and suicide is increased among patients suffering from HS. Creams, tablets, and injections aim to gain disease control, yet are sometimes not sufficient. Once HS tunnels have formed, surgical intervention is often required. Recently, emergence of flexible diode laser fibers has enabled treatment of tunnels from within. The technique has been tested for perianal tunnels and in few studies also for HS tunnels with promising results. Overall, the laser fiber technique is still new, and knowledge of optimal treatment settings is sparse. However, there is reason to believe that intralesional laser fiber treatment of HS tunnels may provide a new tissue-sparing alternative to conventional surgical techniques with a potential to produce fewer side effects, less scaring, shorter downtime after surgery and possibly, also improved inflammatory control. This study aims to investigate the efficacy and safety of laser fiber treatment of HS tunnels. Method The project is carried out at the Dermatological Department, Roskilde University Hospital under the leadership of principal investigator Professor DmSc Gregor Jemec. A prospective cohort study of intralesional laser fiber treatment of HS fistulas is planned. After signing informed consent, patients with two comparable HS tunnels in typical areas will draw lot to receive experimental laser fiber treatment of one tunnel while the other tunnel serve as control. Efficacy will be monitored by pain scores, ultrasound, clinical photos, clinical measures of disease activity, quality-of-life scores, and skin biopsies. Patients will be followed 2, 6, 12 weeks and if possible, also 52 weeks after treatment. After 12 weeks, patients will be offered laser fiber treatment or standard of care surgery to the untreated control tunnel.