View clinical trials related to Rectal Fistula.
Filter by:This observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law .
Phase of Investigation: First-in-human feasibility study Objectives: Primary objective: Demonstration that TIPS microspheres do not compromise the clinical condition or safety of the patient. Secondary objective: To demonstrate that TIPS microspheres facilitate natural healing in the context of perianal fistula. Type of Investigation: First-in-human single site, open label, feasibility study to assess the safety of TIPS microspheres in perianal fistulas and indicative functionality. Investigation design and methods: First-in-human single delivery of a bioabsorbable device to treat perianal fistula. A standard of care internal flap procedure performed to close the internal fistula opening and up to 300 mg of TIPS microspheres will be inserted into each perianal fistula. Participants will be assessed for healing, inflammation, abscess, sepsis, pain and continence by clinical assessments, blood tests, MRI and questionnaires.
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
Rationale: Perianal fistulas are a common incapacitating problem. Many patients are treated by seton drainage to prevent recurrent abscess formation. Nowadays, vessel loops or sutures are used for drainage. The knot of these seton drains can cause complaints of pain or tenderness if it presses against the external opening of the fistula or even slides in to the fistula tract. Medishield B.V. designed a knotless seton drain, the SuperSeton. This could decrease the pain complaints caused by the knot. Objective: The aim of this study is to determine the feasibility of SuperSeton placement in patients with perianal fistulas. Study design: The design of the study is a feasibility study. Study population: Patients (≥ 18 years) with perianal fistulas (ever) treated with a knotted seton are eligible. Intervention: The SuperSeton will be placed at the outpatient clinic in patients that already have a seton in situ. This seton will then be exchanged by the SuperSeton. In case patients do not have a seton in situ, the SuperSeton can be placed at the operating theatre in day care setting instead of a regular seton. Main study parameters/endpoints: The primary outcome is seton failure (loosening of the seton). Secondary outcomes are time of procedure, complications and quality of life measured by the PDAI ('Perianal Disease Activity Index'). Nature and extent of the burden and risks associated with participation: The SuperSeton will be placed in patients with perianal fistulas (ever) treated with a conventional knotted seton. There are no additional risks involved. The seton will be placed at the outpatient clinic in patients with a seton in situ, or at the operating theatre in day care setting in patients with a perianal abscess without a seton. The material that is used for the Setons is of medical grade polyurethane, this is the same material of catheters that are already used in clinical practice (instech BTPU 027). The Setons including the insert (BTPU) are supplied sterile (Synergy Health). Sample size calculation: A group of 60 patients will be included to determine feasibility of the SuperSeton. The proposed treatment protocol is considered feasible if at least 70% of the SuperSetons stay in place.
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.
This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula
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.
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.
A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.
Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal block preoperatively in benign canal anal surgery