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LIFT Technique Versus Seton in Management of Anal Fistula

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ClinicalTrials.gov Identifier: NCT03311035
Recruitment Status : Not yet recruiting
First Posted : October 16, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Abanob Hosny, Assiut University

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 %.


Condition or disease Intervention/treatment Phase
Anal Fistula Procedure: Seton Procedure: LIFT technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Treatment
Official Title: LIFT Technique Versus Seton in Management of Anal Fistula
Estimated Study Start Date : October 18, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Group A
patients undergoing ligation of intersphincteric fistula tract (LIFT technique)
Procedure: LIFT technique
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.

Experimental: Group B
patients undergoing Seton method
Procedure: Seton
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 .




Primary Outcome Measures :
  1. Recurrence of the fistula [ Time Frame: Up to one year from last case ]
    re-appearance of pus discharge or pain after healing of the fistula


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: up to 2 weeks postoperatively for each case ]
    intensity of postoperative pain according to the number of doses needed for analgesia

  2. Fecal Incontinence [ Time Frame: up to 2 months postoperatively for each case ]
    patient complaining of involuntary passage of flatus or stool and confirmed by Digital Rectal examination and Electromyography

  3. Healing time of the wound [ Time Frame: up to 3 months postoperatively for each case ]
    number of days needed for closure of skin at external opening



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311035


Contacts
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Contact: Abanoub hosny, MBBCh 0201019341572 abanob.hosni55555@gmail.com
Contact: Faculty of Medicine Faculty of Medicine-Assiut University

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Abanob Hosny, Resident doctor at General surgery department, Assiut University
ClinicalTrials.gov Identifier: NCT03311035     History of Changes
Other Study ID Numbers: Anal fistula
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases