Anal fistula plug versus endorectal advancement flap for the closure of high criptoglandular fistula-in-ano: a randomised study
ISRCTN | ISRCTN23974417 |
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DOI | https://doi.org/10.1186/ISRCTN23974417 |
Secondary identifying numbers | N/A |
- Submission date
- 29/10/2008
- Registration date
- 20/11/2008
- Last edited
- 20/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hector Ortiz
Scientific
Scientific
C/Trinidad Fernandez Arenas
Pamplona
31002
Spain
Study information
Study design | Interventional randomised single-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised study to compare the results of the anal fistula plug (AFP) with the endorectal advancement flap (ERAF) in the treatment of high fistula-in-ano of cryptoglandular origin |
Study objectives | The use of lyophilised porcine submucosal plugs (Cook Surgisis®, AFPTM) has been proposed as an alternative to conventional surgical techniques for the treatment of anal fistulas. Rates of favourable outcomes are highly variable in the literature (between 13.9% and 87%). Unfortunately, some reports are retrospective studies, others are prospective cohort studies, and only one study has compared the efficacy of this technique with a retrospective review of patients treated with endorectal advancement flap (ERAF). Additionally, these studies include simple and complex anal fistulas, anovaginal fistulas and patients with inflammatory bowel disease. So far, there is not a randomised study comparing the AFP with other surgical procedures suitable for high fistulas. Therefore, the objective of this randomised study was to compare the results of AFP with ERAF in the treatment of high fistula-in-ano of cryptoglandular origin. |
Ethics approval(s) | The Comité Ético de Investigación Clínica of the Health Department of the Government of Navarra (Spain) gave approval on the 2nd April 2007 (ref: Pyto. 14_07). |
Health condition(s) or problem(s) studied | Fistula-in-ano of cryptoglandular origin |
Intervention | All patients underwent full mechanical bowel preparation and received antibiotic and antithromboembolic prophylaxis. The patients were operated on under general anaesthesia in the lithotomy position. Surgical procedures were performed by two surgeons with accredited degrees in Coloproctology (ESBQ Coloproctology). Anal fistula plug (AFP): The plug was submerged in saline for two minutes; the internal fistula orifice was located by injecting hydrogen peroxide. Curettage of the track was not performed. A probe was inserted in the fistula track. The AFP was placed into the tract until resistance was felt and then fixed in place with a 2-0 polyglactin suture (Vicryl®) which included the internal sphincter. The suture was tied in order to close the internal opening of the fistula over the plug. Care was taken to ensure that the external orifice of the fistula was not completely occluded in order to allow the track to drain. The remaining plug was cut at the level of the external opening. Endorectal advancement flap: The tract of the fistula was completely excised, including the internal opening. A rectal flap above the internal opening was mobilised, including the mucosa and submucosa, with a 3 to 4 cm broad base. The rectal flap was mobilised sufficiently to cover the internal opening. Exhaustive haemostasis was performed to avoid a haematoma under the flap. Finally, the flap was sutured to the edge of the anal canal, covering the internal opening. Average duration of treatment: Anal Fistula Plug: 30 minutes Endorectal Advancement Flap: 90 minutes Total duration of follow-up for all arms of your trial: one year |
Intervention type | Other |
Primary outcome measure | Fistula closure rate; recurrence is defined as the presence of an abscess arising in the area, or by obvious evidence of fistulation. Evaluated at 2, 4, 8, 12 weeks after surgery, and at 6, 9 and 12 months. |
Secondary outcome measures | Continence, evaluated pre- and post-operatively (after one year) using the Wexner score. |
Overall study start date | 01/05/2007 |
Completion date | 30/04/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 186 patients (93 in each group) |
Key inclusion criteria | 1. Aged above 18 years, either sex 2. High fistula-in-ano of cryptoglandular origin (the fistulas were defined as high when they included the upper two-thirds of the external sphincter complex) 3. Informed consent |
Key exclusion criteria | 1. Secondary tracts 2. Horseshoe fistulas 3. Anovaginal fistulas 4. Rectouretral fistulas 5. Human immunodeficiency virus (HIV)-positive patients 6. Diagnosed from Crohn's disease |
Date of first enrolment | 01/05/2007 |
Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
C/Trinidad Fernandez Arenas
Pamplona
31002
Spain
31002
Spain
Sponsor information
Hospital Virgen del Camino (Spain) - Public University of Navarra
Hospital/treatment centre
Hospital/treatment centre
C/ Irunlarrea 4
Pamplona
31008
Spain
https://ror.org/046wwv897 |
Funders
Funder type
Hospital/treatment centre
Hospital Virgen del Camino (Spain) - Public University of Navarra
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |