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Long-term Follow-up of Anal Fistula Plug

NCT03961984 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2019-05-23

No results posted yet for this study

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.

Conditions

  • Anal Fistula

Interventions

PROCEDURE

Biodesign® anal fistula plug

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.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Marianne Starck, MD, PhD · Region Skane

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961984 on ClinicalTrials.gov