AzTrials
AzTrials

Anal FistulaLIFTRAFNCT01997645

Surgical Treatment of High Perianal Fistulas

A study testing LIFT and RAF in people with Anal Fistula and Rectal Fistula, run by University Hospital Hradec Kralove at 3 sites in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Fistula, Rectal Fistula
What is being tested?
LIFT and RAF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
3 sitesCzechia
Study dates
Nov 2013to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Recurrent anal fistula
  • Suprasphincteric, low subcutaneous fistula
  • Multiple fistulas
  • Posttraumatic fistula
  • Perianal hidradenitis
  • Fistula arises from other than cryptoglandular origin
Show all 14Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Július Örhalmi, MD contact

+420606506391

orhalmi@volny.cz

Czechia3 sites, 3 recruiting

  • Department of Surgery, Charles University, Faculty of Medicine and University Hospital

    Hradec Králové, 50005

    Július Örhalmi, MD, +420606506391, orhalmi@volny.cz

    Július Örhalmi, MD

    Recruiting

  • Departement of Surgery, District Hospital

    Nový Jičín, 74101

    Karel Klos, MD, +420602412096, kajaanek@gmail.com

    Karel Klos, MD

    Recruiting

  • Departement of Surgery, Military University Hospital

    Prague, 16902

    Zuzana Šerclová, MD, +420602158805, sercl@seznam.cz

    Zuzana Šerclová, MD

    Recruiting

Other trials in Czechia

About this study

Official title: 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.

Read more

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.

Being tested
LIFT, RAF
Keywords
Anal fistula, Rectal fistula, Intersphincteric fistula, Perianal fistula
Medical subject headings
Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIFTProcedure or surgery

  • RAFProcedure or surgery

Study groups in NCT01997645
Study groupRoleWhat they receive
Rectal advanced mucosal flapActive comparatorProcedure 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.
Receives: Procedure: RAF
Ligation of intersphincteric fistula tractActive comparatorProcedure 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.
Receives: Procedure: LIFT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate

    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).

    Measured: One year

Secondary outcomes (4)

  1. Postoperative pain

    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).

    Measured: 14 days

  2. Pre- and postoperative continence

    Pre- and postoperative continence will be evaluated with Wexner score.

    Measured: One year

  3. Postoperative morbidity

    Will be evaluated according to Clavien-Dindo classification.

    Measured: One month

  4. Quality of life

    For quality of life evaluation SF-36 questionnaire will be used.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01997645
Sponsor's protocol ID
FN HK CP 2013
Acronym
LIFTRAF
Status last verified
Nov 2013
First submitted
22 Nov 2013
Last updated
28 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Marks CG, Ritchie JK. Anal fistulas at St Mark's Hospital. Br J Surg. 1977 Feb;64(2):84-91. doi: 10.1002/bjs.1800640203.

    PubMed 890252

  • Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg. 1976 Jan;63(1):1-12. doi: 10.1002/bjs.1800630102.

    PubMed 1267867

  • Malik AI, Nelson RL. Surgical management of anal fistulae: a systematic review. Colorectal Dis. 2008 Jun;10(5):420-30. doi: 10.1111/j.1463-1318.2008.01483.x.

    PubMed 18479308

  • Garcia-Aguilar J, Belmonte C, Wong DW, Goldberg SM, Madoff RD. Cutting seton versus two-stage seton fistulotomy in the surgical management of high anal fistula. Br J Surg. 1998 Feb;85(2):243-5. doi: 10.1046/j.1365-2168.1998.02877.x.

    PubMed 9501826

  • Soltani A, Kaiser AM. Endorectal advancement flap for cryptoglandular or Crohn's fistula-in-ano. Dis Colon Rectum. 2010 Apr;53(4):486-95. doi: 10.1007/DCR.0b013e3181ce8b01.

    PubMed 20305451

  • Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva K. Total anal sphincter saving technique for fistula-in-ano; the ligation of intersphincteric fistula tract. J Med Assoc Thai. 2007 Mar;90(3):581-6.

    PubMed 17427539

  • Yassin NA, Hammond TM, Lunniss PJ, Phillips RK. Ligation of the intersphincteric fistula tract in the management of anal fistula. A systematic review. Colorectal Dis. 2013 May;15(5):527-35. doi: 10.1111/codi.12224.

    PubMed 23551996

  • Sandborn WJ, Fazio VW, Feagan BG, Hanauer SB; American Gastroenterological Association Clinical Practice Committee. AGA technical review on perianal Crohn's disease. Gastroenterology. 2003 Nov;125(5):1508-30. doi: 10.1016/j.gastro.2003.08.025. No abstract available.

    PubMed 14598268

  • Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

    PubMed 8416784

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

Questions about this trial

What is this clinical trial studying?

A study testing LIFT and RAF in people with Anal Fistula and Rectal Fistula, run by University Hospital Hradec Kralove at 3 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Július Örhalmi, MD (+420606506391, orhalmi@volny.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01997645, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.

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