|- candidate number||2623|
|- NTR Number||NTR994|
|- Date ISRCTN created||16-jul-2007|
|- date ISRCTN requested||9-jul-2007|
|- Date Registered NTR||7-jun-2007|
|- Secondary IDs||N/A |
|- Public Title||The Anal Fistula Plug versus the mucosal flap advancement for the treatment of Perianal Fistulas.
|- Scientific Title||The Anal Fistula Plug versus the mucosal flap advancement for the treatment of Perianal Fistulas.|
|- hypothesis||The anal fistula plug is superior in the treatment of high transphincteric fistulas compared to the mucosal advancement flap.|
|- Healt Condition(s) or Problem(s) studied||Perianal fistula|
|- Inclusion criteria||1. High anorectal fistula of cryptoglandular origin (transsfincteric, upper 2/3 of the sfinctercomplex which is confined by the puborectal sling and the end of the anal canal);|
2. Informed consent.
|- Exclusion criteria||1. Age<18 years;|
3. Crohn´s disease;
4. Malignant cause;
6. Hidradenitis suppurativa;
7. Pilonidal sinus disease;
8. No internal opening found during surgery.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2006|
|- planned closingdate||1-okt-2007|
|- Target number of participants||60|
|- Interventions||Installation of the anal fistula plug.|
|- Primary outcome||1. Anorectal fistula closure rate;|
|- Secondary outcome||1. Morbidity;|
2. Post-operative pain;
3. Sick leave;
4. Quality of life.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. J.F.M. Slors|
|- CONTACT for SCIENTIFIC QUERIES||MD. J.F.M. Slors|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Surgery|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Surgery|
|- Brief summary||Background: |
Low transsfincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsfincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the Anal Fistula Plug showed promising results.
To compare the Anal Fistula Plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain.
Patients and Methods:
A total of 60 patients who are planned to undergo surgery because of high perianal fistula will be included in a double blinded randomised controlled trial to compare the Anal Fistula Plug with the mucosal flap advancement. Study parameters will be anorectal fistula closure-rate, quality of life, post-operative pain, and continence.
Follow-up: Patients will be followed-up at two weeks, four weeks, 16 weeks. At the final follow-up closure rate is determined by clinical examination.
|- Main changes (audit trail)|
|- RECORD||7-jun-2007 - 5-jan-2010|