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LIFT Technique Versus Seton in Management of Anal Fistula

Primary Purpose

Anal Fistula

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Seton
LIFT technique
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients who will undergo LIFT technique and Seton for management of anal fistula at General surgery department - Assiut University

Exclusion Criteria:

  • patients under age of 16 years old.
  • patients with malignant fistula.
  • patients with crohn's disease.
  • patients with Tuberculosis.
  • patients with intersphincteric fistula. Patients with anal fistula and anal incontinence

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Arm Description

    patients undergoing ligation of intersphincteric fistula tract (LIFT technique)

    patients undergoing Seton method

    Outcomes

    Primary Outcome Measures

    Recurrence of the fistula
    re-appearance of pus discharge or pain after healing of the fistula

    Secondary Outcome Measures

    Postoperative pain
    intensity of postoperative pain according to the number of doses needed for analgesia
    Fecal Incontinence
    patient complaining of involuntary passage of flatus or stool and confirmed by Digital Rectal examination and Electromyography
    Healing time of the wound
    number of days needed for closure of skin at external opening

    Full Information

    First Posted
    August 25, 2017
    Last Updated
    October 17, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03311035
    Brief Title
    LIFT Technique Versus Seton in Management of Anal Fistula
    Official Title
    LIFT Technique Versus Seton in Management of Anal Fistula
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 18, 2017 (Anticipated)
    Primary Completion Date
    December 1, 2019 (Anticipated)
    Study Completion Date
    December 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology. Anal fistula is the chronic phase of anorectal infection is characterized by chronic purulent drainage or cyclic pain associated with acute relapse of the abscess followed by intermittent spontaneous decompression. Perianal fistulas have a troublesome pathology. The most widely accepted theory is that anal abscess is caused by infection of an anal crypt gland. Suppuration moves from the anal gland to the inter-sphincteric space, forming an abscess leading to the development of a fistula. The incidence of fistula following an abscess is nearly 33%. A fistula can cause pain, perianal swelling, discharge, bleeding, and other nonspecific symptoms. The diagnosis of fistula-in-ano may include a digital rectal examination, endoanal ultrasound, fistulography, and MRI. The management of the disease is difficult and sometimes a challenge for the surgeon. The ideal treatment is based on three central principles: control of sepsis, closure of the fistula and maintenance of continence. The management of complex fistulas needs to balance the outcomes of cure and continence. Success is usually determined by identification of the primary opening and dividing the least amount of muscle as possible. There is a risk of sphincter muscle damage during fistulotomy, which can lead to an unacceptable risk of anal incontinence of varying degrees. The surgical techniques described for the treatment of fistula-in-ano are fistulotomy, core-out fistulectomy, seton placement, endorectal advancement flap, injection of fibrin glue, insertion of a fistula plug, video-assisted anal fistula treatment (VAAFT) and ligation of the intersphincteric fistula tract (LIFT), Surgical techniques are composed of 2 broad categories, including sphincter sacrificing procedures, such as, fistulotomy, fistulectomy and cutting seton. and sphincter-preserving procedures, such as fibrin glue injection, fistula plug, rectal advancement flap, VAAFT and LIFT. In general, sphincter sacrificing procedures have high success rates but are associated with high rates of fecal incontinence. In contrast, sphincter-preserving procedures have more modest success rates but are associated with a relatively minimal risk of changes in continence. While low transsphincteric fistulae are well-addressed by fistulotomy (i.e., lay-open technique) with minimal change in long-term bowel habits, fistulae which involve more than 30 % of the internal sphincter carry a substantial risk of fecal incontinence with this approach. Endorectal advancement flap is technically difficult and associated with high recurrence rate up to 50% and risk of incontinence up to 35%. Fibrin glue and anal fistula plug have a little effect on incontinence but are associated with high recurrence up to 60 % and are costive. VAAFT is effective method but is highly costive. Setons can be employed as cutting and non-cutting kinds as dividers or markers . A few types of setons used are the Ayurveda-medicated thread , braided sutures thread, rubber band , Penrose drains and cable tie seton . Seton material should be non-absorbable, from non-slippage material, comfortable and least irritant for the patient and equally ejective in causing focal reaction in the track, leading to fibrosis . However, setons may cause patient discomfort, both from irritation and from persistent drainage. In addition the incontinence rate may reach 67%. The ligation of intersphincteric fistula tract (LIFT) was first described by Rojanasakul and colleagues in 2007. Since then, this technique has become popular among providers due to its simple technical elements, particularly when compared to anorectal advancement flaps, and favorable success rate. Among the many studies published in the literature, the success rate after LIFT ranges from 40 to 95 %, with a recurrence rate of 6-28 % .3,5-28 In comparison, success after advancement flap ranges from 60 to 94 %.
    Detailed Description
    This study is a prospective study; B) Methodology: Patients will be classified into two groups according to the surgical procedure performed as follows: Group A: Patients undergoing cutting Seton. Group B: Patients undergoing LIFT technique. Aim OF THE STUDY: To compare between Seton and LIFT technique in management of anal fistula according to ; 1-Feasibility of the technique. 3-Postoperative pain and use of analgesia. 4-Healing time. 5-Recurrence rate. 6-Occurrence of fecal incontinence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anal Fistula

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be classified into two groups according to the surgical procedure performed as follows: Group A: Patients undergoing cutting Seton. Group B: Patients undergoing LIFT technique
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    patients undergoing ligation of intersphincteric fistula tract (LIFT technique)
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    patients undergoing Seton method
    Intervention Type
    Procedure
    Intervention Name(s)
    Seton
    Intervention Description
    The identification of the primary tract of the fistula and the placement of the thread can be performed in one single step. a non-absorbable, braided thread is inserted . After excision of the external opening and the extrasphincteric parts of the fistula, the thread is grasped and is pulled out of the anus .The thread is cut in two parts. The mucosa is incised over the muscular bridge . One thread is tied snugly around the muscle; the other is tied loosely .The snugly tied seton has to be replaced after 14 days to provide appropriate tension to cut slowly trough the muscle. This can easily be achieved with the second loosely tied seton . A new thread is folded in the middle and connected to the opened sling of the loose seton using a special knot shown in.The old thread is removed and in the same maneuver two new setons are placed. Again, one thread is tied snugly around the remaining portion of the sphincter muscle; the other is tied loosely .
    Intervention Type
    Procedure
    Intervention Name(s)
    LIFT technique
    Intervention Description
    The internal opening was identified . The intersphincteric plane was entered via a curvilinear incision corresponding to the site of the internal opening at the intersphincteric groove. The intersphincteric plane was developed by meticulous scissor and diathermy dissection up to the tract. Once identified, a small, right-angled clamp was hooked underneath or a tape passed round it. the tract was then transfixed close to the internal sphincter with 2/0 polyglactin suture . Saline was gently injected through the external opening to confirm that the tract was no longer patent and it was then divided distal to the point of ligation . After light traction, a segment of the distal tract was excised and, if needed, any defect in the external sphincter was closed. The intersphincteric incision wound was re-approximated loosely with interrupted 2/0 Vicryl. Partial core-out of the fistula tract was performed from the external opening to the external sphincter.
    Primary Outcome Measure Information:
    Title
    Recurrence of the fistula
    Description
    re-appearance of pus discharge or pain after healing of the fistula
    Time Frame
    Up to one year from last case
    Secondary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    intensity of postoperative pain according to the number of doses needed for analgesia
    Time Frame
    up to 2 weeks postoperatively for each case
    Title
    Fecal Incontinence
    Description
    patient complaining of involuntary passage of flatus or stool and confirmed by Digital Rectal examination and Electromyography
    Time Frame
    up to 2 months postoperatively for each case
    Title
    Healing time of the wound
    Description
    number of days needed for closure of skin at external opening
    Time Frame
    up to 3 months postoperatively for each case

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients who will undergo LIFT technique and Seton for management of anal fistula at General surgery department - Assiut University Exclusion Criteria: patients under age of 16 years old. patients with malignant fistula. patients with crohn's disease. patients with Tuberculosis. patients with intersphincteric fistula. Patients with anal fistula and anal incontinence
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abanoub hosny, MBBCh
    Phone
    0201019341572
    Email
    abanob.hosni55555@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Faculty of Medicine Faculty of Medicine-Assiut University

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    All patients were discharged with analgesics and stool softeners and received oral ofloxacin and metronidazole for 1 week. Before being discharged, the patients were shown how to clean their wound and were advised to take topical antibiotic ointment. After hospital discharge, patients were seen 2 week after the initial procedure. The second consultation was 2 weeks after the first visit and the third visit will be after 6 month from the operation and the fourth visit will be after one year from the operation .At each visit the patient was interviewed for clinical continence status. The intersphincteric incision wound was examined, the sites of the previous internal and external openings were palpated and sphincter tone was assessed. After healing, the patient was asked to return should any recurrent pain, swelling or discharge occur. All patients with a documented healed fistula were also contacted by telephone at the time of the present study to enquire of possible recurrence.
    Citations:
    PubMed Identifier
    21876616
    Citation
    Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.
    Results Reference
    background
    PubMed Identifier
    28271064
    Citation
    Xu Y, Tang W. Ligation of Intersphincteric Fistula Tract Is Suitable for Recurrent Anal Fistulas from Follow-Up of 16 Months. Biomed Res Int. 2017;2017:3152424. doi: 10.1155/2017/3152424. Epub 2017 Feb 8.
    Results Reference
    background
    PubMed Identifier
    27878618
    Citation
    Chen HJ, Sun GD, Zhu P, Zhou ZL, Chen YG, Yang BL. Effective and long-term outcome following ligation of the intersphincteric fistula tract (LIFT) for transsphincteric fistula. Int J Colorectal Dis. 2017 Apr;32(4):583-585. doi: 10.1007/s00384-016-2723-2. Epub 2016 Nov 23.
    Results Reference
    background
    PubMed Identifier
    27013849
    Citation
    Khadia M, Muduli IC, Das SK, Mallick SN, Bag L, Pati MR. Management of Fistula-In-Ano with Special Reference to Ligation of Intersphincteric Fistula Tract. Niger J Surg. 2016 Jan-Jun;22(1):1-4. doi: 10.4103/1117-6806.169818.
    Results Reference
    background
    PubMed Identifier
    22609079
    Citation
    Mushaya C, Bartlett L, Schulze B, Ho YH. Ligation of intersphincteric fistula tract compared with advancement flap for complex anorectal fistulas requiring initial seton drainage. Am J Surg. 2012 Sep;204(3):283-9. doi: 10.1016/j.amjsurg.2011.10.025. Epub 2012 May 19.
    Results Reference
    background
    PubMed Identifier
    18158881
    Citation
    Charua-Guindic L, Mendez-Moran MA, Avendano-Espinosa O, Jimenez-Bobadilla B, Charua-Levy E. [Complex anal fistula treated with cutting seton]. Cir Cir. 2007 Sep-Oct;75(5):351-6. Spanish.
    Results Reference
    background
    PubMed Identifier
    25472892
    Citation
    Ye F, Tang C, Wang D, Zheng S. Early experience with the modificated approach of ligation of the intersphincteric fistula tract for high transsphincteric fistula. World J Surg. 2015 Apr;39(4):1059-65. doi: 10.1007/s00268-014-2888-1.
    Results Reference
    background
    PubMed Identifier
    25441733
    Citation
    Zirak-Schmidt S, Perdawood SK. Management of anal fistula by ligation of the intersphincteric fistula tract - a systematic review. Dan Med J. 2014 Dec;61(12):A4977.
    Results Reference
    background

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    LIFT Technique Versus Seton in Management of Anal Fistula

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