The anal fistula PLUG versus the mucosal flap advancement for the treatment of perianal fistulas
| ISRCTN | ISRCTN97376902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97376902 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 16/07/2007
- Registration date
- 16/07/2007
- Last edited
- 31/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.F.M. Slors
Scientific
Scientific
Academic Medical Centre
Afd. Chirurgie
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| j.f.slors@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The anal fistula PLUG versus the mucosal flap advancement for the treatment of perianal fistulas |
| Study acronym | PLUG |
| Study objectives | The anal fistula plug is superior in the treatment of high transphincteric fistulas compared to the mucosal advancement flap. |
| Ethics approval(s) | Approval received from the Medical Ethics Committee AMC, Amsterdam on the 23rd August 2006 (ref: MEC 06/204). |
| Health condition(s) or problem(s) studied | Perianal fistula |
| Intervention | installation of the anal fistula plug versus mucosal flap. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Anorectal fistula closure rate |
| Key secondary outcome measure(s) |
1. Morbidity |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | 31/12/2020 | Yes | No |
| Protocol article | protocol | 23/06/2008 | 31/12/2020 | Yes | No |
Editorial Notes
31/12/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.
