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VAAFT: Endoscopic Treatment of Complex Anal Fistulas

Sponsor
University of Southern Denmark (Other)
Overall Status
Terminated
CT.gov ID
NCT02585167
Collaborator
Odense University Hospital (Other)
47
Enrollment
1
Location
2
Arms
62.9
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.

Condition or Disease Intervention/Treatment Phase
  • Procedure: operation
  • Device: VAAFT
 N/A

Detailed Description

The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Operation

the fistula will be excised after dividing the sphincter and primary reconstruction .

Procedure: operation
the fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage.
Other Names:
  • Fistulectomy and primary sphincter reconstruction

    		•
    Experimental: VAAFT

    the fistula tract will be visualized by scope, closing the internal opening with absorbable sutures.

    Device: VAAFT
    Karl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage.

    Outcome Measures

    Primary Outcome Measures

    1. The recurrence rate of perianal fistula [6 months]

      A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.

    Secondary Outcome Measures

    1. changes in quality of life score [baseline and 6 months]

      A comparison on changes in quality of life, using The Short Form (36) Health Survey in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.

    2. changes in fecal incontinence score [baseline and 6 months]

      A comparison on changes in Wexner score in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.

    3. changes in manometric study [baseline and 6 months]

      A comparison on changes in manometric study(including maximum resting pressure, maximum squeeze pressure) in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with complex transsphincteric anal fistulas >18 yrs old.
    Exclusion Criteria:

    • Crohns fistulas

    • Signs of suppuration or/and branching.

    • Malignancy within 5 yrs.

    • Previous radiotherapy of the abdomen and pelvis.

    • Current Immune- suppressive treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • University of Southern Denmark
    • Odense University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Karam Matlub Sørensen, læge, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT02585167
    Other Study ID Numbers:
    • S-20150053
    First Posted:
    Oct 23, 2015
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Karam Matlub Sørensen, læge, University of Southern Denmark
    VAAFT
    anal fistula
    sphincter reconstruction
    Additional relevant MeSH terms:
    Rectal Fistula
    Fistula

    Study Results

    No Results Posted as of May 14, 2021