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Rectal Fistula clinical trials

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NCT ID: NCT06243302 Active, not recruiting - Anal Fistula Clinical Trials

Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration

VAAFT-OTSC
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.

NCT ID: NCT05499156 Active, not recruiting - Clinical trials for Perianal Fistula in Patients With Crohn's Disease

Safety of Injection of Placental Mesenchymal Stem Cell Derived Exosomes for Treatment of Resistant Perianal Fistula in Crohn's Patients

Start date: January 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

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

NCT ID: NCT05263661 Active, not recruiting - Anal Fistula Clinical Trials

Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula

LIFTRAF-RCT
Start date: January 1, 2013
Phase: Phase 3
Study type: Interventional

Objective: Rectal advancement flap (RAF) is currently considered the gold standard in the treatment of complex anal fistula (CAF). Clinical trials are a priority given the few consistent results available with level 1 evidence. We compare the results of two conservative sphincter techniques: ligation of intersphincteric fistula tract (LIFT) versus RAF. Material and Method: A controlled, randomised clinical trial is conducted in patients operated between 2013 and 2016 in Hospital General Universitario Reina Sofia, Murcia, Spain. The primary objective was to evaluate relapse at 12 months of follow-up, and the secondary objectives were post-op anal continence (Wexner), post-operative complications (haematoma, infection of surgical site, suture dehiscence), duration of surgery and hospitalisation. Post-operative controls 1, 3, 6 and 12 months after surgery.

NCT ID: NCT04796376 Active, not recruiting - High Anal Fistula Clinical Trials

The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula

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

The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

NCT ID: NCT04377542 Active, not recruiting - Anal Fistula Clinical Trials

RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton

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

LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula. This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.

NCT ID: NCT04118088 Active, not recruiting - Crohn's Disease Clinical Trials

A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

EMPIRE
Start date: December 22, 2020
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04075825 Active, not recruiting - Crohn's Disease Clinical Trials

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Start date: November 4, 2019
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03878498 Active, not recruiting - Crohn Disease Clinical Trials

Management of Anal Fistula of Crohn Disease

FISTUCROHN
Start date: June 19, 2018
Phase:
Study type: Observational

The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

NCT ID: NCT01931371 Active, not recruiting - Anal Fistula Clinical Trials

Anal Fistula Plug Versus Endorectal Advancement Flap

AFPERAF
Start date: May 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

NCT ID: NCT00517296 Active, not recruiting - Crohn Disease Clinical Trials

Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

Start date: January 2008
Phase: N/A
Study type: Interventional

This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.