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

Primary Purpose

Transsphincteric Anal Fistula

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LIFT
fistulectomy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transsphincteric Anal Fistula focused on measuring anal fistula, LIFT, fistulectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with transsphincteric anal fistula

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.

Sites / Locations

  • Zagazig Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A , LIFT

group B fistulectomy

Arm Description

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

39 patients under went fistulectomy for treatment of transsphincteric fistula

Outcomes

Primary Outcome Measures

recurrence
recurrence of the fistula after complete healing of wound detected by clinical examination
incontinence
inability to control flatus or stool detected by Vaizy patient questionnaire
operative time
time from 1st incision to wound packing counted in minutes
hospital stay
from admission to discharge measured in days
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

Secondary Outcome Measures

wound complications
bleeding and local wound infection detected by clinical examination

Full Information

First Posted
April 15, 2020
Last Updated
April 16, 2020
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04351074
Brief Title
Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Ffistula.
Acronym
professor
Official Title
Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Fistula. Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transsphincteric Anal Fistula
Keywords
anal fistula, LIFT, fistulectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) group B (39 patients): Patients underwent fistulectomy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A , LIFT
Arm Type
Active Comparator
Arm Description
39 patients underwnt ligation of the intersphincteric track( LIFT) for treatment of transsphincteric fistula
Arm Title
group B fistulectomy
Arm Type
Active Comparator
Arm Description
39 patients under went fistulectomy for treatment of transsphincteric fistula
Intervention Type
Procedure
Intervention Name(s)
LIFT
Intervention Description
ligation of the intersphincteric fistula track
Intervention Type
Procedure
Intervention Name(s)
fistulectomy
Intervention Description
excision of the fistulous track with its internal and external orifices
Primary Outcome Measure Information:
Title
recurrence
Description
recurrence of the fistula after complete healing of wound detected by clinical examination
Time Frame
8 weeks
Title
incontinence
Description
inability to control flatus or stool detected by Vaizy patient questionnaire
Time Frame
1 week
Title
operative time
Description
time from 1st incision to wound packing counted in minutes
Time Frame
1 hour
Title
hospital stay
Description
from admission to discharge measured in days
Time Frame
1 day
Title
postoperative pain
Description
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 Outcome Measure Information:
Title
wound complications
Description
bleeding and local wound infection detected by clinical examination
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with transsphincteric anal fistula 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hazem nour, MD
Organizational Affiliation
zag university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig Faculty of Medicine
City
Zagazig
State/Province
Sharqya
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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