MedTrace Logo

Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula

NCT01612195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2013-05-17

No results posted yet for this study

Summary

Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The course of abscess-fistula disease as well as its treatment modalities may affect anal continence. The present cohort study investigates the results of anal fistula plug surgery. In particular, this study focus on the impact of anal fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons.

Conditions

  • Complex Anal Fistula

Interventions

PROCEDURE

Anal fistula plug

All patients have a draining seton for at least 6 weeks prior placement of the anal fistula plug. All patients are administered a general anesthetic and are operated in the lithotomy position. The seton is removed, but no curettage or irrigation of the fistula tract is performed. The plug is inserted through the internal opening, and pulled through the external opening until it fit snugly and its base is sutured to the internal sphincter with 2 interrupted 2-0 polyglactin 910 sutures. The tip of the plug is cut at skin level and not sutured. The external opening is left open to allow for drainage. The patient is instructed to restrict physical and sexual activity for 2 weeks postoperatively. Patients are seen in the post-operative clinic at 10 days, 6 weeks and 6 months as per protocol.

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER

  • Women's College Hospital

    collaborator OTHER

  • St. Claraspital AG

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Michel Adamina, MD, PD, MSc · University of Basel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-03-31
Completion
2012-01-31

Countries

  • Switzerland

More Related Trials

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 NCT01612195 on ClinicalTrials.gov