Long-term Follow-up of Anal Fistula Plug
1 other identifier
observational
95
1 country
1
Brief Summary
Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedMay 23, 2019
May 1, 2019
3.4 years
May 8, 2019
May 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Fistula recurrence; Technical failure
Plug fallen out
Week 2
Fistula recurrence; Infection
Surgical site infection
Week 2
Fistula recurrence; Infection
Surgical site infection
Month 3
Fistula recurrence; Infection
Surgical site infection
Month 6-12
Fistula recurrence; Infection
Surgical site infection
Through study completion, an average of 8 years
Fistula recurrence; New opening
Faeces coming through external opening
Week 2
Fistula recurrence; New opening
Faeces coming through external opening
Month 3
Fistula recurrence; New opening
Faeces coming through external opening
Month 6-12
Fistula recurrence; New opening
Faeces coming through external opening
Through study completion, an average of 8 years
Study Arms (1)
Complex anal fistula
Patients with complex transsphincteric anal fistulas were treated with Biodesign® plug.
Interventions
Patient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage.
Eligibility Criteria
All patients with anal fistulas not treatable with a simple fistulotomy offered to participate.
You may qualify if:
- complex transsphincteric anal fistula
You may not qualify if:
- ano/rectovaginal fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Skåne University Hospital
Malmo, Sweden
Related Publications (1)
Aho Falt U, Zawadzki A, Starck M, Bohe M, Regner S, Johnson LB. Postoperative three-dimensional endoanal ultrasound findings and relation to anal fistula plug failure. Scand J Gastroenterol. 2023 Jul-Dec;58(10):1200-1206. doi: 10.1080/00365521.2023.2212310. Epub 2023 May 18.
PMID: 37203207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marianne Starck, MD, PhD
Region Skane
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2019
First Posted
May 23, 2019
Study Start
May 1, 2006
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
May 23, 2019
Record last verified: 2019-05