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Showing 1-20 of 35 trials
NCT06918808
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
NCT04118088
The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.
NCT06632418
The average success rate for healing and remission of complex perianal fistulas, idiopathic or Crohn's-related, is approximately 50%. These abnormal connections between the rectum and the outside skin remain a major clinical challenge in need of new treatments aimed at tissue repair. Platelet-derived growth factor drives wound healing and tissue regeneration, and manufactured PDGF is currently used to heal diabetic foot ulcers and regenerate bone in periodontal and orthopedic patients. Manufactured recombinant human PDGF has the potential to improve the success rate for complete healing of complex perianal fistulas, reduce the recurrence rate due to reopening of the fistula tract, and avoid complications associated with routine surgical interventions.
NCT07019532
This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.
NCT05039411
Objectives: Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).
NCT06962228
The investigators verify the reliability and practicality of the Chinese adaptation results of QoLAF-Q, which helps Chinese doctors better master the methods and techniques of quality of life assessment.
NCT04075825
The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
NCT06803550
This study aims to assess the role of Enhanced recovery after surgery(ERAS) protocol in reducing postoperative urine retention (POUR) after surgery for benign anorectal conditions.
NCT06441526
Currently, the treatment of Crohn's patients with perianal fistulas predominantly exists of anti-TNF medication. However, its efficiency has never been directly compared to surgical closure of the perianal fistula. The aim of this study is to compare radiological fistula healing at MRI after 18 months follow-up in Crohn's patients undergoing surgical closure to anti-TNF medication as treatment of perianal Crohn's fistulas. Study design: In this multicenter comprehensive cohort design (CCD) Crohn's patients with a (re)active high perianal fistula will be allocated to anti-TNF for 1 year or surgical closure after 2 months under a short course of anti-TNF. Patients with a distinct preference will be treated accordingly, whereas only indifferent patients will be randomised in the usual way. Main study parameters/endpoints: The primary outcome parameter is the number of patients with radiologically closed fistulas based on an evaluated MRI-score after 18 months. Secondary outcomes are clinical closure, number of patients undergoing surgical re-interventions and number of re-interventions, recurrences and quality of life based on the Perianal Disease Activity Index (PDAI). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will receive one of the two standard treatment approaches that are currently used for Crohn's fistulas. All effort has been performed to ensure most optimal treatment, according to best available evidence and current guidelines. Since there is no experimental study-arm, there are no additional risks associated with participation. During the study, the medical staff and trial nurses will monitor the necessity of surgical interventions and hospitalizations. At baseline and after 18 months all patients will undergo a MRI to score the fistula. Secondary outcome parameters will be assessed during visits to the outpatient clinic or telephone consultations at baseline and at intervals of 3 months for the duration of the study period. Every 6 months patients were asked to fill out the PDAI questionnaire with their physician. Based on the available literature, radiological closure of fistulas is expected in 40% of patients in the surgical closure group compared to 15% in the anti-TNF group. The increase in closure rate from 15% to 40% is considered clinically relevant. Due to the combination of a preference and randomized cohort, the appropriate sample size to detect this 25% difference is flexible and is adjusted for a skewed distribution. The minimal sample size, in case of a 1:1 treatment allocation, needed to detect this difference with a Chi-square test equals 86 patients (alpha 0.05, power 80%). The maximal allowed skewed distribution is set at 1:4, which will result in a maximal sample size of 116 patients.
NCT06421129
The goal of this observational study is to understand the effects of anatomical factors, etiology, and complexity of anal fistula on the prognosis of patients undergoing anal fistula surgery within one year post-operation.The main question it aims to answer is: Which factors are indicative of the prognosis of anal fistula surgery? Which factors are landmark factors of anal fistulas? Participants who have already undergone anal fistula surgery at our hospital will receive outpatient and telephone follow-up to assess their prognosis.
NCT06314945
Perianal fistula is a common anal problem. It needs only surgery. MRI is the best preoperative diagnostic tool, but it is demanding as it is expensive, time consuming and needs an experienced radiologist. So, we tried to find an alternative diagnostic tool which is cheaper, time saving and accurate and comparing its preoperative reports with intraoperative findings. study was held in surgery department in Zagazig University Hospitals from September 2023 to March 2024. It included 93 patients with perianal fistula who were diagnosed clinically and radiological by trans recto-perineal ultrasound and comparing pre-operative ultrasound findings with intra-operative surgical findings.
NCT02306382
Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence. Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal. The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.
NCT05721794
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
NCT04178707
Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.
NCT05499156
Study aim: Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of perianal fistula in patients with Crohn's disease 2. Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula in patients with Crohn's disease 3. Fistula changes in MRI studies, 12 weeks after treatment 4. Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment Participants/Inclusion and exclusion criteria: inclusion criteria: 1. Age between 18-70 years old 2.Occurrence in patients with Crohn's disease 3. Informed consent Exclusion Criteria: 1. Active inflammatory bowel disease 2. Synchronous perianal abscess 3. Alcohol, narcotics and stimulant consumption 4. Having active Hepatitis B, C, HIV, or TB 5. Pregnancy and lactation 6.Uncontrolled diabetes mellitus 7. Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient Intervention groups: Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes, and it's safety and efficacy were evaluated. Design: this study includes two separate groups of cases and controls, each consisting of 40 participants randomly allocated for phase 2 of a clinical trial. Settings and conduct: Patients with complex perianal fistula referred to Imam Khomeini hospital will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination, and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for three consecutive weeks. Patients will be reexamined and fill out the questionnaire, and MRI will be done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examined for complications. Main outcome variables: Discharge amount; External orifice re-epithelialization; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin
NCT05201209
Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve sphincter function. Indeed, management is mainly based on fistulotomy techniques, but the latter expose patients to a significant alteration of their continence (less than 10% incontinence for simple fistulas but 30-50% for complex fistulas). In addition, these fistulas' management is constraining for patients due to the need for multiple interventions, long-term post-operative care and repeated discontinuation of activity. Sphincteral saving techniques have therefore developed over the last three decades and have enriched the therapeutic panel of complex fistulas. They aim to block fistula pathways without risking altering sphincter function. In addition, their surgical consequences are often simple. However, they are associated with a greater risk of failure than after fistulotomy and sometimes disappointing to the point that some of these techniques have been gradually abandoned (biological glue and plug for example). Among these sphincteral saving techniques, the investigators know the advancement flap, the injection of biological glue, plug's installation, the LIFT (Ligation of Inter sphincteric Fistula Tract), the clip's use but also, more recently a laser treatment, FiLaC™ (for Fistula Laser Closure), knowing that the idea was not new since the ND-YAG3 and CO24.5 lasers were already used in the treatment of anal fistulas, about twenty years ago, in experimental studies. This technique consists of radiating 360° laser energy radially into the fistula path to "burn" it and causing thermal destruction by coagulation of the fistula wall ans granulation tissue2. It can bo offered to any type of fistula at risk on continence, including horseshoe extensions that can be treated at the same time. It is well suited for outpatient management because the postoperative period is simple and painless. The literature is still poor on the subject with some studies published openly but the preliminary results are encouraging with a success rate of about 70%. No continence disorders reported.
NCT03861689
Perianal Crohn's disease (pCD) affects around one-third of patients with Crohn's disease (CD) during their disease course. It represents a distinct disease phenotype and causes significant morbidity, often requiring multiple surgical interventions. However, treatment of pCD is still challenging and unsatisfactory. Only approximately one-third of pCD patients responded to biologic treatment. Overall, medical therapy with anti-TNF could only achieve prolonged remission in 30-40% of pCD cases. At the same time, surgical treatment could only lead to a favourable outcome in around 50% of patients with a higher recurrence rate in patients with complex than in simple fistulae. Recently, combination of optimal medical therapy with surgical therapy (drainage of sepsis and insertion of seton), with radiological guidance, has been suggested as the standard management so as to improve the outcomes of complex pCD. Magnetic resonance imaging (MRI) is considered to be the gold standard imaging technique for perianal CD. It can visualise the anal sphincter and the pelvic floor muscles, as well as the fistula tracts and abscesses. Previous studies using MRI to monitor treatment response to anti-TNF revealed that radiological healing lagged behind clinical remission by a median of 12 months and that long-term maintenance therapy is probably required to prevent recurrence despite a clinically healed external opening. Therefore, we hypothesize that serial monitoring with MRI is important. Recently, there has been some advance in the surgical treatment of perianal Crohn's disease. FiLaCTM uses a radial-emitting disposable laser fibre for endofistular therapy. Recent systemic review and meta-analysis showed that the primary success rate was 73.3% (11/15) in patients with perianal Crohn's fistula. There has been breakthrough in the management of luminal Crohn's disease. The CALM study has showed that timely escalation of anti-TNF on the basis of clinical symptoms combined with biomarkers in patients with luminal Crohn's disease resulted in better clinical and endoscopic outcomes than symptom-driven decision alone. It is unsure whether this approach is also applicable to patients with perianal Crohn's disease.
NCT02423330
This clinical trial will evaluate the safety and efficacy of the Strattice-LIFT procedure to treat anal fistulas.
NCT03981939
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
NCT04811105
Perianal fistula(PF) is one of the most frequent disease in anorectal disease.The incidence of PF is 8,6 -10 / 100 000 . The first surgical treatment is defined by Hippocrates in PF .This surgical treatment which found by Hippocrates , involves seton insertion into the tract of fistula . Today most of surgeon still use the same technic but PF is really hard disease to treat. Recurrence rate of PF is really high and there are lots of complication about this disease. The most scary complication during the surgery or postoperatively is anal disfunction. ın PF surgical technics involves ;fistulectomy (coring out), lay open (fistulotomy), Ligation of Intersphincteric Fistula Tract, advancement flap and laser ablation of the fistula tract . The popularity of laser ablation of the fistula tract is increasing day by day.This surgical procedure is applied with the laser device which use in varicose vain ablation in vascular surgery.In this study the investigator are trying to find out the effect of steam ablation in PF on rats.