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Rectal Fistula clinical trials

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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: 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: NCT05044182 Recruiting - Anal Fistula Clinical Trials

Decompression and Drainage Seton for Treatment of High Horseshoe Anal Fistula

DADS
Start date: October 8, 2021
Phase: N/A
Study type: Interventional

Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting seton.

NCT ID: NCT05039411 Recruiting - Fistula in Ano Clinical Trials

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease

Start date: March 1, 2022
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT04847739 Recruiting - Crohn's Disease Clinical Trials

Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)

Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.

NCT ID: NCT04790123 Recruiting - Anal Fistula Clinical Trials

Adipose Tissue Injection for the Treatment of Complex Cryptoglandular Perianal Fistula

AdiTiF
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

The incidence of complex cryptoglandular anal fistula is high, it affects eminently young patients and implies an important alteration in their quality of life and high prevalence in sick leave. Its treatment remains a real challenge due to the limited efficacy of sphincter preservation techniques and the inevitable risk of faecal incontinence in those cases that require surgery. Goals: To evaluate the efficacy and safety of the injection of freshly collected autologous adipose tissue as a minimally invasive, highly reproducible alternative, without risk for the continence of the patient, and of very low cost, in the treatment of complex cryptoglandular anal fistula. Methodology: Prospective multicenter, randomized, double-blinded, parallel-group, placebo-controlled clinical trial. Randomization list for each center to ensure the balance of inter-center allocation. Patients older than 18 years with cryptoglandular anal fistula with suppuration for more than 6 weeks and less than 1 year, who have received at most: curettage and drainage placement will be included. Treatment group: injection of fresh autologous fat into the fistulous tract, after curettage and closure of the internal orifice, and after lipoaspirate fat in the abdomen and centrifugation thereof. Placebo group: curettage and closure of the internal orifice and simulated intervention in the abdomen. Evaluation: protocolized clinical history and fistula complexity score (CFS), subjective perception of its pathology, St.Marks continence score, Quality of life questionnaire (QoLAF), and endoanal 3D ultrasound, at baseline, at one week, and at 3, 6 and 12 months after the intervention. The patients and the evaluator will be blind to the treatment. Patients who cannot end up receiving treatment due to intraoperative incidents or medical decision will be excluded from the study (post randomization exclusion). In each center there will be a blind evaluator to perform the follow-ups and endoanal ultrasound.

NCT ID: NCT04750499 Recruiting - Anal Fistula Clinical Trials

Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection

Fistula_CM1
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.

NCT ID: NCT04701411 Recruiting - Crohn's Disease Clinical Trials

A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present. The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel. 2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic. For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment).

NCT ID: NCT04616911 Recruiting - Anal Fistula Clinical Trials

Rerouting Seton Versus LIFT for Complex Anal Fistula

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

This study aims to compare the efficacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.

NCT ID: NCT04418323 Recruiting - Clinical trials for Video Assisted Anal Fistula Treatment

Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula

Start date: June 16, 2020
Phase: N/A
Study type: Interventional

Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal with one or more than one external openings in the perianal skin Aim of the work This prospective randomized control trial, we will compare video-assisted anal fistula treatment (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital stay, pain score, healing time, return to work and continence