Trial record 2 of 109 for:    Open Studies | "Fistula"

Surgical Treatment of High Perianal Fistulas (LIFTRAF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital Hradec Kralove
Sponsor:
Information provided by (Responsible Party):
Otakar Sotona, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier:
NCT01997645
First received: November 22, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Anal Fistula
Rectal Fistula
Procedure: LIFT
Procedure: RAF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ligation of Intersphincteric Fistula Tract (LIFT) Versus Rectal Advanced Mucosal Flap (RAF) in Surgical Treatment of High Perianal Fistulas

Resource links provided by NLM:


Further study details as provided by University Hospital Hradec Kralove:

Primary Outcome Measures:
  • Recurrence rate [ Time Frame: One year ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pre- and postoperative continence will be evaluated with Wexner score.

  • Postoperative morbidity [ Time Frame: One month ] [ Designated as safety issue: No ]
    Will be evaluated according to Clavien-Dindo classification.

  • Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
    For quality of life evaluation SF-36 questionnaire will be used.


Estimated Enrollment: 140
Study Start Date: November 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997645

Contacts
Contact: Július Örhalmi, MD +420606506391 orhalmi@volny.cz

Locations
Czech Republic
Department of Surgery, Charles University, Faculty of Medicine and University Hospital Recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Július Örhalmi, MD    +420606506391    orhalmi@volny.cz   
Principal Investigator: Július Örhalmi, MD         
Departement of Surgery, District Hospital Recruiting
Novy Jicin, Czech Republic, 74101
Contact: Karel Klos, MD    +420602412096    kajaanek@gmail.com   
Principal Investigator: Karel Klos, MD         
Departement of Surgery, Military University Hospital Recruiting
Prague, Czech Republic, 16902
Contact: Zuzana Šerclová, MD    +420602158805    sercl@seznam.cz   
Principal Investigator: Zuzana Šerclová, MD         
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
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
  More Information

Publications:

Responsible Party: Otakar Sotona, MD, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT01997645     History of Changes
Other Study ID Numbers: FN HK CP 2013
Study First Received: November 22, 2013
Last Updated: November 22, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Hradec Kralove:
Anal fistula
Rectal fistula
Intersphincteric fistula
Perianal fistula

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014