Anal fistula plug versus endorectal advancement flap for the closure of high criptoglandular fistula-in-ano: a randomised study

ISRCTN	ISRCTN23974417
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

C/Trinidad Fernandez Arenas
Pamplona
31002
Spain

Study information

Study design	Interventional randomised single-centre trial
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
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

Sponsor information

Hospital Virgen del Camino (Spain) - Public University of Navarra
Hospital/treatment centre

C/ Irunlarrea 4
Pamplona
31008
Spain

"ROR"	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
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