Surgical Treatment of High Perianal Fistulas (LIFTRAF)

November 22, 2013 updated by: Otakar Sotona, University Hospital Hradec Kralove

Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 50005
        • Recruiting
        • Department of Surgery, Charles University, Faculty of Medicine and University Hospital
        • Contact:
        • Principal Investigator:
          • Július Örhalmi, MD
      • Novy Jicin, Czech Republic, 74101
        • Recruiting
        • Departement of Surgery, District Hospital
        • Contact:
        • Principal Investigator:
          • Karel Klos, MD
      • Prague, Czech Republic, 16902
        • Recruiting
        • Departement of Surgery, Military University Hospital
        • Contact:
        • Principal Investigator:
          • Zuzana Šerclová, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Procedure: LIFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
14 days
Pre- and postoperative continence
Time Frame: One year
Pre- and postoperative continence will be evaluated with Wexner score.
One year
Postoperative morbidity
Time Frame: One month
Will be evaluated according to Clavien-Dindo classification.
One month
Quality of life
Time Frame: One year
For quality of life evaluation SF-36 questionnaire will be used.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Július Örhalmi, MD, University hospital Hradec Králové
  • Principal Investigator: Zuzana Šerclová, MD, Central Military Hospital Prague
  • Principal Investigator: Karel Klos, MD, District Hospital Nový Jičín

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 22, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FN HK CP 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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