Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula
Primary Purpose
Fistula in Ano
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fistulotomy and marsupialization
fistulectomy and wound closure
Sponsored by
About this trial
This is an interventional treatment trial for Fistula in Ano focused on measuring fistula in ano, fistulectomy wound closure, fistulotomy wound marsupialization
Eligibility Criteria
Inclusion Criteria:
• patients above 18 years diagnosed with simple non recurrent anal fistula.
Exclusion Criteria:
- Anorectal malignancy.
- Specific disease (Crohn's disease).
- ASA class III, VI and any contraindication for surgery
- Immunocompromized patients and those on steroid therapy or cytotoxic drugs.
- Perianal collection.
Sites / Locations
- Zagazig Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fistulotomy group
fistulectomy group
Arm Description
46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges
46 patients with simple anal fistula underwent fistulectomy and closure of the wound
Outcomes
Primary Outcome Measures
healing time
time taken for complete epithelialization of the wound detected by clinical examination
number of participants with recurrence of anal fistula
presence of anal fistula after complete wound healing detected by clinical examination
number of participants with anal incontinence
inability to control stool or flatus diagnosed by Vaizey score questionaire
Secondary Outcome Measures
number of participants with postoperative pain and its degree
degree of postoperative pain detected by visual analogue scale calculation
number of participants with post operative complications
post operative complications as bleeding and wound infection detected by clinical examination
operative time
time of the procedures calculated in minutes starting with the first incision to the start of wound dressing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04215718
Brief Title
Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula
Official Title
Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula, a Comparative Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (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
comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula
Detailed Description
the investigators conducted this comparative clinical trial in the period between April 2017 and March 2019, on 92 patients with simple anal fistula, patients were randomly allocated into 2 groups, group I the fistulotomy group; 46 patients they underwent fistulotomy and marsupialization of wound edges. Group II, the fistulectomy group they underwent fistulectomy with closure of the wound.
Randomization was done using computer generated cards, the trial was approved by institutional review board (IRB) and the ethical committee of our hospitals, all study participants signed an informed written consent.
The condition of this trial is simple anal fistula defined as non-branched fistula confined to the lower third of the anal sphincter diagnosed by anorectal examination or MRI if needed, the primary outcomes are; the time taken for complete healing, fistula recurrence and anal incontinence diagnosed by Vaizey score patient's questionnaire. The secondary outcomes are local wound complications and postoperative pain calculated by visual analogue score (VAS). Study participants number was calculated through the IRB depending on the incidence of simple anal fistula in our locality.
inclusion criteria
• patients above 18 years diagnosed with simple non recurrent anal fistula.
exclusion criteria:
Anorectal malignancy.
Specific disease (Crohn's disease).
ASA class III, VI and any contraindication for surgery
Immunocompromised patients and those on steroid therapy or cytotoxic drugs.
Perianal collection. participants of this study were subjected to proper history taking and full clinical examination for diagnosis of the condition, detection of any associated disease and \ or exclusion factor. MRI was ordered if there is any doubt about diagnosis, preoperative investigations were ordered as per usual.
The procedure in both groups was carried out by the study surgeons, under general anesthesia in lithotomy position, anorectal examination was done to identify the internal and external openings, course of fistulous track and any side tracks if present. When the internal opening couldn't be identified the operator used methylene blue dye injection through the external opening. In fistulotomy group and after probing of the track it was let open by diathermy, its floor was curetted and the wound edges marsupialized by polygalactin (Vicryl) sutures 3\0.
In fistulectomy group and after probing, the fistulous track was excised by diathermy together with its internal and external openings, after hemostasis the wound was closed by polygalactin (Vicryl) sutures 3\0.
In both groups the wound was dressed with non-adhesive dressing, Nonsteroidal analgesics were given as per need and participants were discharged after 24 hours if there is no contraindication to do so.
After discharge study participants were encouraged for self-cleaning by antiseptic baths.
Follow up was carried out in the outpatient clinics by the study surgeons, the clinic visits were planed every week for 12 weeks then monthly for another three months, in each visit the investigator recorded the state of wound healing, anal continence, postoperative pain, any local wound complications, and any recurrence after complete healing in the follow up time.
Preoperative data, demographic data, operative time, intraoperative complications and follow up data were collected and properly analyzed using paired t test and Z tests in SPSS 22 program package.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fistula in Ano
Keywords
fistula in ano, fistulectomy wound closure, fistulotomy wound marsupialization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups of patients with simple anal fistula each one 46 patients the1st underwent fistulotomy with marsupialization of wound edges the second underwent fistulectomy and wound closure
Masking
Participant
Masking Description
the patients don't know which procedure they underwent
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fistulotomy group
Arm Type
Active Comparator
Arm Description
46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges
Arm Title
fistulectomy group
Arm Type
Active Comparator
Arm Description
46 patients with simple anal fistula underwent fistulectomy and closure of the wound
Intervention Type
Procedure
Intervention Name(s)
fistulotomy and marsupialization
Intervention Description
the anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\0 sutures
Intervention Type
Procedure
Intervention Name(s)
fistulectomy and wound closure
Intervention Description
anal fistula was excised with both openings and the wound was closed
Primary Outcome Measure Information:
Title
healing time
Description
time taken for complete epithelialization of the wound detected by clinical examination
Time Frame
8 weeks
Title
number of participants with recurrence of anal fistula
Description
presence of anal fistula after complete wound healing detected by clinical examination
Time Frame
6 months
Title
number of participants with anal incontinence
Description
inability to control stool or flatus diagnosed by Vaizey score questionaire
Time Frame
i months
Secondary Outcome Measure Information:
Title
number of participants with postoperative pain and its degree
Description
degree of postoperative pain detected by visual analogue scale calculation
Time Frame
1 week
Title
number of participants with post operative complications
Description
post operative complications as bleeding and wound infection detected by clinical examination
Time Frame
1 week
Title
operative time
Description
time of the procedures calculated in minutes starting with the first incision to the start of wound dressing
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• patients above 18 years diagnosed with simple non recurrent anal fistula.
Exclusion Criteria:
Anorectal malignancy.
Specific disease (Crohn's disease).
ASA class III, VI and any contraindication for surgery
Immunocompromized patients and those on steroid therapy or cytotoxic drugs.
Perianal collection.
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
No
Learn more about this trial
Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula
We'll reach out to this number within 24 hrs