Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04351074 |
| Other study ID # |
LIFT VS fistulectomy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
February 28, 2020 |
Study information
| Verified date |
April 2020 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
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