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Anal Fistula clinical trials

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NCT ID: NCT06303752 Not yet recruiting - Anal Fistula Clinical Trials

Tissue Therapy of Transsphincteric Anal Fistula

REP-PAF
Start date: May 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

NCT ID: NCT06092398 Not yet recruiting - Anal Fistula Clinical Trials

Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula

Start date: September 2024
Phase: N/A
Study type: Interventional

To evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula To asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula

NCT ID: NCT06049524 Not yet recruiting - Postoperative Pain Clinical Trials

Could Preoperative Assessment of Physical and Psychological Status Help Predict Pain After Anorectal Surgery?

Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this single-center prospective observational trial is to study the influence of physical and psychological factors on the intensity of pain syndrome after anorectal interventions and to determine the association between the physiological pain threshold before surgery and the level of pain syndrome after anorectal surgery. Participants undergoing surgical treatment for anorectal diseases will be asked to complete the questionnaires before and after surgery, all information will be collected to identify risk factors for severe pain syndrome after surgery. The pain threshold test will be conducted to determine the association with pain after surgery.

NCT ID: NCT05974280 Not yet recruiting - Crohn Disease Clinical Trials

Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

CHAZAM
Start date: January 2024
Phase:
Study type: Observational

One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells. The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy. This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed. Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided. An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities. We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.

NCT ID: NCT05933343 Not yet recruiting - Anal Fistula Clinical Trials

Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.

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: 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: NCT03311035 Not yet recruiting - Anal Fistula Clinical Trials

LIFT Technique Versus Seton in Management of Anal Fistula

Start date: October 18, 2017
Phase: N/A
Study type: Interventional

Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology. Anal fistula is the chronic phase of anorectal infection is characterized by chronic purulent drainage or cyclic pain associated with acute relapse of the abscess followed by intermittent spontaneous decompression. Perianal fistulas have a troublesome pathology. The most widely accepted theory is that anal abscess is caused by infection of an anal crypt gland. Suppuration moves from the anal gland to the inter-sphincteric space, forming an abscess leading to the development of a fistula. The incidence of fistula following an abscess is nearly 33%. A fistula can cause pain, perianal swelling, discharge, bleeding, and other nonspecific symptoms. The diagnosis of fistula-in-ano may include a digital rectal examination, endoanal ultrasound, fistulography, and MRI. The management of the disease is difficult and sometimes a challenge for the surgeon. The ideal treatment is based on three central principles: control of sepsis, closure of the fistula and maintenance of continence. The management of complex fistulas needs to balance the outcomes of cure and continence. Success is usually determined by identification of the primary opening and dividing the least amount of muscle as possible. There is a risk of sphincter muscle damage during fistulotomy, which can lead to an unacceptable risk of anal incontinence of varying degrees. The surgical techniques described for the treatment of fistula-in-ano are fistulotomy, core-out fistulectomy, seton placement, endorectal advancement flap, injection of fibrin glue, insertion of a fistula plug, video-assisted anal fistula treatment (VAAFT) and ligation of the intersphincteric fistula tract (LIFT), Surgical techniques are composed of 2 broad categories, including sphincter sacrificing procedures, such as, fistulotomy, fistulectomy and cutting seton. and sphincter-preserving procedures, such as fibrin glue injection, fistula plug, rectal advancement flap, VAAFT and LIFT. In general, sphincter sacrificing procedures have high success rates but are associated with high rates of fecal incontinence. In contrast, sphincter-preserving procedures have more modest success rates but are associated with a relatively minimal risk of changes in continence. While low transsphincteric fistulae are well-addressed by fistulotomy (i.e., lay-open technique) with minimal change in long-term bowel habits, fistulae which involve more than 30 % of the internal sphincter carry a substantial risk of fecal incontinence with this approach. Endorectal advancement flap is technically difficult and associated with high recurrence rate up to 50% and risk of incontinence up to 35%. Fibrin glue and anal fistula plug have a little effect on incontinence but are associated with high recurrence up to 60 % and are costive. VAAFT is effective method but is highly costive. Setons can be employed as cutting and non-cutting kinds as dividers or markers . A few types of setons used are the Ayurveda-medicated thread , braided sutures thread, rubber band , Penrose drains and cable tie seton . Seton material should be non-absorbable, from non-slippage material, comfortable and least irritant for the patient and equally ejective in causing focal reaction in the track, leading to fibrosis . However, setons may cause patient discomfort, both from irritation and from persistent drainage. In addition the incontinence rate may reach 67%. The ligation of intersphincteric fistula tract (LIFT) was first described by Rojanasakul and colleagues in 2007. Since then, this technique has become popular among providers due to its simple technical elements, particularly when compared to anorectal advancement flaps, and favorable success rate. Among the many studies published in the literature, the success rate after LIFT ranges from 40 to 95 %, with a recurrence rate of 6-28 % .3,5-28 In comparison, success after advancement flap ranges from 60 to 94 %.