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Surgical Treatment of High Perianal Fistulas (LIFTRAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01997645
Recruitment Status : Unknown
Verified November 2013 by Otakar Sotona, University Hospital Hradec Kralove.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Otakar Sotona, University Hospital Hradec Kralove

Tracking Information
First Submitted Date  ICMJE November 22, 2013
First Posted Date  ICMJE November 28, 2013
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
Recurrence rate [ Time Frame: One year ]
Fistula recurrence will be defined according to AGA (American Gastroenterological Association) criteria as a purulent secretion from external fistula opening followed the compression. Fistula recurrence will be confirmed by evaluation under anesthesia (followed by drainage).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • Postoperative pain [ Time Frame: 14 days ]
    Postoperative pain will be assessed 4 times per day during the first 2 postoperative days (VAS - visual analogue scale), after that 3 times per day over next 14 days (patient's diary).
  • Pre- and postoperative continence [ Time Frame: One year ]
    Pre- and postoperative continence will be evaluated with Wexner score.
  • Postoperative morbidity [ Time Frame: One month ]
    Will be evaluated according to Clavien-Dindo classification.
  • Quality of life [ Time Frame: One year ]
    For quality of life evaluation SF-36 questionnaire will be used.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Treatment of High Perianal Fistulas
Official Title  ICMJE Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas
Brief Summary

Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.

Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.

Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).

The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anal Fistula
  • Rectal Fistula
Intervention  ICMJE
  • Procedure: LIFT
  • Procedure: RAF
Study Arms  ICMJE
  • Active Comparator: Rectal advanced mucosal flap

    Procedure will be performed in general anesthesia without mechanical bowel preparation. Antibiotic prophylaxis (Metronidazole 1g) will be applied intravenously 60 minutes prior the surgery.

    In RAF procedure, internal opening will identified and after infiltration with saline-adrenalin solution (1/100000) the mucosal flap will be mobilized proximally. The external tract and internal opening will be excised and the defect will be sutured. After that, the flap will be advanced from both sides with absorbable suture and overlapped over the internal opening. External openings will be left open.

    Intervention: Procedure: RAF
  • Active Comparator: Ligation of intersphincteric fistula tract

    Procedure will be performed in general anesthesia without mechanical bowel preparation. Antibiotic prophylaxis (Metronidazole 1g) will be applied intravenously 60 minutes prior the surgery.

    Before LIFT procedure the fistula tract will be identified with small probe. The intersphincteric space will be reached by dissection from small (2-4cm) incision. The fistula tract will be divided and ligated on both sides with Polydioxanone (PDS) suture. The external and internal openings will be left open to drain.

    Intervention: Procedure: LIFT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
140
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 years old or older
  • Diagnosis of simple intersphincteric or transsphincteric fistula
  • Patients able to comply with the study protocol as per investigator criteria
  • Signed and dated informed consent by the patient
  • Absence of any exclusion criteria

Exclusion Criteria:

  • Recurrent anal fistula
  • Suprasphincteric, low subcutaneous fistula
  • Multiple fistulas
  • Posttraumatic fistula
  • Perianal hidradenitis
  • Fistula arises from other than cryptoglandular origin
  • Previous anal surgery except of abscess
  • Inflammatory Bowel Disease
  • History of fecal incontinence
  • Rectal prolapse
  • Malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment
  • HIV infection
  • Pregnancy
  • Participation in another clinical trial less than one month prior to enrolment, or involvement in another trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01997645
Other Study ID Numbers  ICMJE FN HK CP 2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otakar Sotona, University Hospital Hradec Kralove
Study Sponsor  ICMJE University Hospital Hradec Kralove
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Július Örhalmi, MD University Hospital Hradec Kralove
Principal Investigator: Zuzana Šerclová, MD Central MIlitary Hospital Prague
Principal Investigator: Karel Klos, MD District Hospital Nový Jičín
PRS Account University Hospital Hradec Kralove
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP