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Anal Fistula clinical trials

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NCT ID: NCT04811105 Completed - Anal Fistula Clinical Trials

INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS

STEAM
Start date: November 10, 2018
Phase: N/A
Study type: Interventional

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.

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: NCT04740086 Completed - Anal Fistula Clinical Trials

"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"

Start date: January 1, 2016
Phase:
Study type: Observational

Background: Complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence. Biological sealants have emerged as an effective alternative for maintaining the integrity of the anal sphincter. The investigators aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the tract as treatment for complex cryptoglandular fistulas. Methods: A prospective, single-center, case series of this novel technique was conducted in a level 3 hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6, and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the 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: NCT04541238 Not yet recruiting - Anal Fistula Clinical Trials

Imaging Template for Reporting Anal Fistula

ITRAF
Start date: September 1, 2020
Phase:
Study type: Observational

Magnetic resonance imaging (MRI) is the most used diagnostic tool for pre-operative assessment of anal fistula. However, there is lack of standardization in reporting this investigation. Moreover, reports may miss a number of key information for surgical planning. The aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.

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: NCT04326907 Completed - Anal Fistula Clinical Trials

Treatment of Complex Anal Fistulas Using Centrifuged Adipose Tissue Containing Progenitor Cells

CAT
Start date: May 1, 2016
Phase: N/A
Study type: Interventional

In the treatment of complex anal fistulas transplant of freshly collected autologous adipose tissue mechanically fragmented or centrifuged adipose tissue (CAT) might be an alternative to in vitro expanded autologous or allogeneic adipose-derived stem cells, showing remarkable efficacy in diverse therapeutic indications. The aim of our study is to evaluate randomly the efficacy and safety of the use of CAT in the healing process of complex anal fistulas, except for Crohn's disease (CD) related fistulas.

NCT ID: NCT04310800 Recruiting - Anal Fistula Clinical Trials

LIFT-plug vs LIFT, a RCT Trial

LIFT 02
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers

NCT ID: NCT04190862 Recruiting - Anal Fistula Clinical Trials

E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

Start date: January 22, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.