NCT01612195

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

2.2 years

First QC Date

June 2, 2012

Last Update Submit

May 16, 2013

Conditions

Complex Anal Fistula

Keywords

anal fistulaanal continencehealth-related quality of life

Outcome Measures

Primary Outcomes (3)

  • Fistula healing

    Clinical healing of a complex anal fistula as assessed in the clinic at 6 weeks and 6 months after anal fistula plug surgery. Further assessment prn.

    6 months

  • Anal continence

    Evaluation of anal continence by means of a validated questionnaire, namely the Fecal Incontinence Severity Index, at 6 weeks and 6 months after anal fistula plug surgery.

    6 months

  • Quality of life

    Evaluation of health-related quality of life by means of a validated questionnaire, namely the Short-Form 36 version 2, at 6 weeks and 6 months after anal fistula plug surgery.

    6 months

Study Arms (1)

Anal fistula plug

EXPERIMENTAL
Procedure: Anal fistula plug

Interventions

Anal fistula plugPROCEDURE

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.

Also known as: Anal fistula plug Surgisis®
Anal fistula plug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complex anal fistula as defined by
  • high transsphincteric fistula
  • extrasphincteric fistula
  • suprasphincteric fistula
  • recurrent fistula
  • multiple fistula openings, including horseshoe fistula
  • imperfect continence- jeopardized anal continence (anterior transsphincteric fistula, prior anal surgery)

You may not qualify if:

  • Uncomplicated fistula curable by simple fistulotomy
  • History of inflammatory bowel disease
  • Chronic immunosuppressive treatment (ie, systemic steroids for \>3 days)
  • Clinical heart failure as defined by a CCS angina severity class ≥ III
  • Untreated cancer or cancer diagnosed/treated (all modalities) within 6 months
  • Estimated life expectancy inferior to 6 months
  • Incompetent subject
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel & Kantonsspital St.Gallen

Basel & St.Gallen, 4031 & 9007, Switzerland

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michel Adamina, MD, PD, MSc

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 2, 2012

First Posted

June 5, 2012

Study Start

January 1, 2007

Primary Completion

March 1, 2009

Study Completion

January 1, 2012

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations

CH(1)