Surgical Treatment of High Perianal Fistulas

NCT01997645 | Unknown DMC

• 1 other identifier: FN HK CP 2013
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

Conditions

Anal Fistula; Rectal Fistula

Keywords

Anal fistula; Rectal fistula; Intersphincteric fistula; Perianal fistula

Outcome Measures

Primary Outcomes (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).

  One year

Secondary Outcomes (4)

• Postoperative pain

  14 days

• Pre- and postoperative continence

  One year

• Postoperative morbidity

  One month

• Quality of life

  One year

Study Arms (2)

Rectal advanced mucosal flap

ACTIVE COMPARATOR

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

Ligation of intersphincteric fistula tract

ACTIVE COMPARATOR

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

Interventions

LIFT PROCEDURE

Ligation of intersphincteric fistula tract

RAF PROCEDURE

Rectal advanced mucosal flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (3)

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

Hradec Králové, 50005, Czechia

RECRUITING

Departement of Surgery, District Hospital

Nový Jičín, 74101, Czechia

RECRUITING

Departement of Surgery, Military University Hospital

Prague, 16902, Czechia

RECRUITING

Related Publications (10)

• 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.

  PMID: 890252 BACKGROUND

• 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.

  PMID: 1267867 BACKGROUND

• 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.

  PMID: 18479308 BACKGROUND

• 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.

  PMID: 9501826 BACKGROUND

• 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.

  PMID: 20305451 BACKGROUND

• 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.

  PMID: 17427539 BACKGROUND

• 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.

  PMID: 23551996 BACKGROUND

• 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.

  PMID: 14598268 BACKGROUND

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

  PMID: 8416784 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Július Örhalmi, MD

CONTACT

+420606506391; orhalmi@volny.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

CZ (3)