CClinicalTrials.gg
CompletedNCT04351074professorUpdated Apr 20, 2020

Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Ffistula.

An interventional study of LIFT and fistulectomy in Transsphincteric Anal Fistula, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Mar 2018, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

78 patients with transsphincteric fistula allocated into two groups group A underwent LIFT group B u nderwent fistulectomy , comparison between the outcome og both procedures

Read the detailed description

This randomized comparative clinical trial was carried out in Zagazig university hospitals, general surgery department, between March 2018 and February 2020, on 78 patients with transsphincteric anal fistula.

All patients were informed and signed a written consent for participation in this study, the study was approved by the local ethical committee of our university the sample size was calculated by the statistical unit of the local institutional review board participant selection; participant included in this study are those above 18 years old, suffering transsphincteric anal fistula diagnosed by clinical examination and magnetic resonant imaging (MRI) in doubtful cases, We excluded all patients with;

  • Anorectal malignancy.
  • Patient with previous radiotherapy to the region.
  • Those with fistula due to specific disease as Crohn's disease.
  • Patients with anal incontinence.
  • Patients with perianal collections.
  • Patients on cytotoxic or immunosuppressive therapy. Randomization; According to intervention,participants were randomly allocated using computer generated random numbers into two groups, group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) and group B (39 patients): Patients underwent fistulectomy.

Procedures ; All participants were subjected to full clinical examination including detailed history, formal digital rectal examination for assessment of anal sphincter integrity, identification of internal and external openings of the fistula, MRI was performed in those with doubtful clinical examination. Preoperative investigations performed according to American society of anesthesia (ASA) guidelines, all patients received 1 gm third generation cephalosporin with induction of anesthesia and continued for 24 hours postoperative, fleet enema was performed 12 hours and 2 hours before operation.

Surgical technique;

Under spinal anesthesia, participants under went digital rectal examination for identification of the internal and external openings and the fistulous track course, after identification of the external opening it was propped by 14 g cannula through which 2ml hydrogen peroxide was injected and traced through anoscope inside anal canal to identify the internal opening, after that the fistulous track was propped by malleable metal probe, the definitive procedure was then performed according to patient allocation:

in group A; a curvilinear incision was taken in the groove between internal and external anal sphincters over the track course, it was deepened by sharp and blunt dissection between both sphincters till reaching the propped fistulous track, using monopolar diathermy when needed, the track was dissected all around at this point, we used Vicryl 3\0 suture to ligate the fistulous track at two points the medial one as near as possible to the internal sphincter the lateral one is close as possible to the external sphincter, the track was cut in between both ligatures, the lateral part of the track was curetted and the skin around the internal opening was trimmed.

In group B; after identification and probing of the track fistulectomy was carried out by carrying out elliptical incision including internal and external openings, the fistulous track was excised severing the related part of the anal sphincters.

Hemostasis was achieved as needed, wounds was dressed using non adherent dressing, patients received non-steroidal analgesia as per need, patients was discharged after tolerating oral intake.

Follow up; It was achieved via outpatient clinics by the attending surgeon,participants were instructed to attend the clinic every week till complete wound healing , 3 and 6 months after wound healing, later on patients were contacted by phone after 1 year of the procedure, data to be collected throughout follow up included postoperative pain measured by visual analogue scale (VAS) , state of wound healing, state of continence measured by Vaizey score patient's questionnaire, recurrence or persistence of the fistula measured by history and clinical examination.

Statistical analysis; Operative and hospital stay time together with follow up data were collected and statistically analyzed using paired t test and Z test in SPSS program package 22

02

Conditions studied

  • Transsphincteric Anal Fistula

Keywords

  • anal fistula, LIFT, fistulectomy
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 78 is above the median of 68 across 130 interventional studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with transsphincteric anal fistula

Exclusion criteria

Exclusion Criteria:

  • Anorectal malignancy.
  • Patient with previous radiotherapy to the region.
  • Those with fistula due to specific disease as Crohn's disease.
  • Patients with anal incontinence.
  • Patients with perianal collections.
  • Patients on cytotoxic or immunosuppressive therapy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Active comparator
    group A , LIFT

    39 patients underwnt ligation of the intersphincteric track( LIFT) for treatment of transsphincteric fistula

    Procedure: LIFT

  • Active comparator
    group B fistulectomy

    39 patients under went fistulectomy for treatment of transsphincteric fistula

    Procedure: fistulectomy

Interventions

  • ProcedureLIFT

    ligation of the intersphincteric fistula track

  • Procedurefistulectomy

    excision of the fistulous track with its internal and external orifices

06

What researchers measure

Primary outcomes

  1. recurrence

    recurrence of the fistula after complete healing of wound detected by clinical examination

    Time frame: 8 weeks

  2. incontinence

    inability to control flatus or stool detected by Vaizy patient questionnaire

    Time frame: 1 week

  3. operative time

    time from 1st incision to wound packing counted in minutes

    Time frame: 1 hour

  4. hospital stay

    from admission to discharge measured in days

    Time frame: 1 day

  5. postoperative pain

    degree of pain measured by patient questionnaire visual analogue scale(from 1 to 10) the high the score the more sever the pain is

    Time frame: 1 day

Secondary outcomes

  1. wound complications

    bleeding and local wound infection detected by clinical examination

    Time frame: 1 week

07

Study locations

1 site
  • Zagazig Faculty of Medicine
    Zagazig, Sharqya 44519, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04351074
Lead sponsor
Zagazig University
Responsible party
Hazem Nour Abdellatif (Assistant professor, Zagazig University) — Principal investigator
First posted
Apr 17, 2020
Start date
Mar 1, 2018
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Last update
Apr 20, 2020

Study contacts

hazem nour, MD
principal investigator · zag university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion