View clinical trials related to Rectal Fistula.
Filter by:In this pilot study a new surgical treatment approach for perianal fistulae, called Fistulodesis, is performed. The study aims to assess effectiveness, safety and tolerability of the Fistulodesis procedure. The investigators are aiming to include 20 patients with Crohn's disease and 20 patients without underlying Crohn's disease. It is an open label study with an anticipated duration from January 2017 to January 2020.
The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-[X]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.
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 %.
The anal complex fistula constitutes a challenge in proctologic surgery because of the of its therapeutic care complexity due to the frequency of recurrences and the necessity to protect the sphincter function. For several years,differents techniques were developed "said sphincter sparing techniques" to handle fistulas at risk on the anal continence. Recently there is one of them , named FiLAC using a clip system not yet evaluated. The purpose is to assess the success rate of his new surgery technique.
This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas).
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter. Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure. Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity. Evaluations : - Fistula clinical healing 6 and 12 months after procedure - Fistula MRI healing 12 months after procedure - Anal continence before and after procedure - Feasibility og radiofrequency procedure - Morbidity - Success and failure prognostics factors of this procedure
The primary aim is to test the magnitude and duration of analgesia provided by single dose multi-drug analgesia administered for perianal block, and compare with standard solution (Marcaine & Lidocaine in 1:1 mixture - Total 60 ml), at post-operative period and also to compare with the standard solution including their respective post-operative opioid or non-opioid oral analgesic requirement. Local anesthesia via a perianal block using multi-drug analgesia or standard solution will be compared using the Numeric pain rating scale on Post-operative day 1, 3 and during follow up visit on day 7. The investigators hope to find a better control of post-operative analgesia which will lead to better functional outcomes. Possible decrease consumption of opioids in the post-operative period will perhaps decrease the cost and chances of addiction and will increase patient comfort and compliance.
Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.
The purpose of this study is to determine whether treatment with laser coagulation is an effective and safe treatment option for patients with anal fistula
.Rerouting operation takes the advantage of minimal recurrence rate as well as minimal incontinence that is associated with less sphincter division,It is indicated in patients with transsphincteric fistula in whom lay open is expected to be associated with significant incontinence .