Condition category
Digestive System
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
27/07/2007
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

Dr J.F.M. Slors

ORCID ID

Contact details

Academic Medical Centre
Afd. Chirurgie
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 9111
j.f.slors@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PLUG

Study hypothesis

The anal fistula plug is superior in the treatment of high transphincteric fistulas compared to the mucosal advancement flap.

Ethics approval

Approval received from the Medical Ethics Committee AMC, Amsterdam on the 23rd August 2006 (ref: MEC 06/204).

Study design

Multicentre, randomised, double blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Perianal fistula

Intervention

installation of the anal fistula plug versus mucosal flap.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Anorectal fistula closure rate
2. Continence

Secondary outcome measures

1. Morbidity
2. Post-operative pain
3. Sick leave
4. Quality of life

Overall trial start date

01/10/2006

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1.High anorectal fistula of cryptoglandular origin (transphincteric, upper 2/3 of the sphincter complex which is confined by the puborectal sling and the end of the anal canal)
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Aged less than 18 years
2. Human Immunodeficiency Virus (HIV)-positive
3. Crohn's disease
4. Malignant cause
5. Tuberculosis
6. Hidradenitis suppurativa
7. Pilonidal sinus disease
8. No internal opening found during surgery

Recruitment start date

01/10/2006

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl#http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

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