Anal Fistula Clinical Trial
— flapOfficial title:
Treatment of Anal Fistulas by Partial Rectal Wall Advancement Flap or Mucosal Advancement Flap: a Prospective Randomized Study
Verified date | May 2005 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
This study comprises a prospective study of 40 patients with transphincteric anal fistula. The patients were classified into two groups: Group I: Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa, submucosa, and circular muscle layer sutured 1cm below the level of internal opening. Group II: The same as group one but the flap includes only mucosa and submucosa.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with transphincteric anal fistula Exclusion Criteria: - Patients with acute sepsis, specific cause of fistula, strictured anorectum, and any degree of incontinence |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Hospital | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Christoforidis D, Pieh MC, Madoff RD, Mellgren AF. Treatment of transsphincteric anal fistulas by endorectal advancement flap or collagen fistula plug: a comparative study. Dis Colon Rectum. 2009 Jan;52(1):18-22. doi: 10.1007/DCR.0b013e31819756ac. — View Citation
Chung W, Kazemi P, Ko D, Sun C, Brown CJ, Raval M, Phang T. Anal fistula plug and fibrin glue versus conventional treatment in repair of complex anal fistulas. Am J Surg. 2009 May;197(5):604-8. doi: 10.1016/j.amjsurg.2008.12.013. — View Citation
Dixon M, Root J, Grant S, Stamos MJ. Endorectal flap advancement repair is an effective treatment for selected patients with anorectal fistulas. Am Surg. 2004 Oct;70(10):925-7. — View Citation
Dubsky PC, Stift A, Friedl J, Teleky B, Herbst F. Endorectal advancement flaps in the treatment of high anal fistula of cryptoglandular origin: full-thickness vs. mucosal-rectum flaps. Dis Colon Rectum. 2008 Jun;51(6):852-7. doi: 10.1007/s10350-008-9242-3 — View Citation
Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendáriz P, de Miguel M. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano. Br J Surg. 2009 Jun;96(6):608-12. doi: 10.1002/bjs. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RECURRENCE OF THE FISTULA | 12 months | Yes | |
Secondary | healing, complication, patient satisfaction | 12 month | Yes |
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