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Anal Fistula clinical trials

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NCT ID: NCT05805449 Recruiting - Anal Fistula Clinical Trials

BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

BIO RAMP
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

NCT ID: NCT05641844 Recruiting - Anal Fistula Clinical Trials

A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal Fistulas

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assesses the safety of autologous RD2 Ver.02 as compared to a control for managing transsphincteric and intersphinsteric anal fistulas. The main questions it aims to answer are: Assess the safety and efficacy of RD2 Ver.02 in anal fistula application, compared to control. Complication rate by 6 months of anal fistula treatment with RD2 Ver.02 compared to control. Recurrence of anal fistula at 12 months post-treatment Incidence of perirectal infection by 6 months in anal fistulas treated with RD2 Ver.02 compared to control. Patients will be randomized in to 2 arms. For all patients, blood will be drawn to ensure the blinding of the patients, the fistula will be evaluated and debrided, and then the internal fistula opening will be suture-closed, and a water leak test will be performed to ensure sealing. Following the water leak test, In the treatment arm, the patient's own coagulating blood will be applied into the entire fistula tract, allowing it to clot and serve as a provisional matrix inside the fistula tract. In the control arm, the blood sample will be discarded and saline will be applied to the fistula tract.

NCT ID: NCT05638139 Recruiting - Anal Fistula Clinical Trials

Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment With a Gel and Plug of Wharton's Jelly

Start date: June 27, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.

NCT ID: NCT05605080 Completed - Hemorrhoids Clinical Trials

Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery

Start date: November 7, 2022
Phase: N/A
Study type: Interventional

To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

NCT ID: NCT05476146 Not yet recruiting - Anal Fistula Clinical Trials

Re-routing in Treatment High Anal Fistula

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?

NCT ID: NCT05348473 Recruiting - Quality of Life Clinical Trials

Changes in Patients' Quality of Life With Differences in Seton Application

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

Investigators aim to investigate the changes in patients' quality of life with different type of seton application.

NCT ID: NCT05314205 Completed - Anal Fistula Clinical Trials

Ligation of Inter-sphincteric Fistula Tract for Management of Anal Fistula

Start date: January 1, 2019
Phase:
Study type: Observational

After abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. The goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. Patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. All patients had the identical anesthetic approach, followed by the operation with two years' follow-up.

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: NCT05243966 Recruiting - Clinical trials for Hidradenitis Suppurativa

Myriad™ Augmented Soft Tissue Reconstruction Registry

MASTRR
Start date: January 10, 2022
Phase:
Study type: Observational [Patient Registry]

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

NCT ID: NCT05134168 Completed - Anal Fistula Clinical Trials

LIFT With or Without Injection of BM-MNCs

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

To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia. A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.