Condition category
Digestive System
Date applied
29/10/2008
Date assigned
20/11/2008
Last edited
20/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hector Ortiz

ORCID ID

Contact details

C/Trinidad Fernandez Arenas
Pamplona
31002
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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).

Study design

Interventional randomised single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2007

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

186 patients (93 in each group)

Participant 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

Recruitment start date

01/05/2007

Recruitment end date

30/04/2009

Locations

Countries of recruitment

Spain

Trial participating centre

C/Trinidad Fernandez Arenas
Pamplona
31002
Spain

Sponsor information

Organisation

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

Sponsor details

C/ Irunlarrea 4
Pamplona
31008
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes