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Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain

Primary Purpose

Anal Fistula

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fistulotomy and marsupialization of wound edges
fistulotomy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring simple anal fistula, marsupialization

Eligibility Criteria

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

Inclusion Criteria:

  • Simple non recurrent perianal fistula with ASA I and II.

Exclusion Criteria:

  • secondary anal fistula,
  • complex fistula,
  • anal incontinence,
  • previous anal surgery
  • Any disease or drug that affects wound healing.

Sites / Locations

  • Zagazig Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A fistulotomy group

group B marsupialization group

Arm Description

35 patients with simple anal fistula subjected to fistulotomy

35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound

Outcomes

Primary Outcome Measures

operative time in minutes
the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization
postoperative pain using visual analogue scale
pain in the postoperative period
postoperative complications measured by clinical examination and anal sphincter manometry
examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence
wound healing time
time taken for wound to be completely healed

Secondary Outcome Measures

Full Information

First Posted
November 2, 2019
Last Updated
November 6, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04155905
Brief Title
Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain
Official Title
Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 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 to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time
Detailed Description
This randomized controlled trial was carried in the period between May 2018 and April 2019, on 70 patients undergoing fistulotomy for treatment of simple perianal fistula. Patients were randomly allocated into two equal groups each 35 patients, group A; underwent fistulotomy without marsupialization of the edges of fistulotomy wound. And group B; underwent fistulotomy with marsupialization of the wound edges. Patients included in this study are those suffering simple non recurrent perianal fistula with ASA I and II. the investigator excluded patients with secondary anal fistula, complex fistula, anal incontinence, previous anal surgery and any disease or drug that affects wound healing. All patients were subjected to thorough history taking and careful anal examination to assess the sphincter integrity, define the fistulous track and internal opening, endo anal ultrasound or magnetic resonance imaging was ordered when needed. Fistulotomy was done under spinal anesthesia in the lithotomy position after skin preparation and patient draping; anal examination under anesthesia was done, identification of the internal opening carried out using palpation and inspection using proctoscope, injection of hydrogen peroxide in the external opening done if internal opening couldn't be defined easily, then the fistulous track was probed, it was laid open using diathermy, in group B the wounds was marsupialized by suturing the skin edges to the edges of the track floor using absorbable sutures (polygalactin) 3\0. Figures (1) and (2) shows the probed fistulous track and its' wound after marsupialization. Postoperative non adherent dressing impregnated with local anesthetic cream was applied to the wound. Nonsteroidal analgesic injection was given in injection form as per need. Follow up was carried out in outpatient clinic by the study surgeons, patients who agreed for participation in the study was instructed to visit the clinic every week for the first three post-operative months then every month for the next 3 months and lastly two visits after 3 and 6 months, the attending surgeon records follow up data including status of wound healing, anal continence and fistula recurrence. An informed written consent was taken from all study participants. Randomization was done using computer program. The study was approved from institutional review board and the ethical committee from our university. Demographic data, operative data, and postoperative data including pain, post-operative complications and time taken for complete wound healing were collected, properly analyzed using the paired t test and Z test using SPSS program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
simple anal fistula, marsupialization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparison between two groups of patients with simple anal fistula subjected to different types of treatment
Masking
Participant
Masking Description
patients don't know the procedure
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A fistulotomy group
Arm Type
Active Comparator
Arm Description
35 patients with simple anal fistula subjected to fistulotomy
Arm Title
group B marsupialization group
Arm Type
Active Comparator
Arm Description
35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound
Intervention Type
Procedure
Intervention Name(s)
fistulotomy and marsupialization of wound edges
Intervention Description
after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\0 sutures
Intervention Type
Procedure
Intervention Name(s)
fistulotomy
Intervention Description
after defining the fistulous track it was laid open (marsupialization)
Primary Outcome Measure Information:
Title
operative time in minutes
Description
the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization
Time Frame
intraoperative
Title
postoperative pain using visual analogue scale
Description
pain in the postoperative period
Time Frame
1 week
Title
postoperative complications measured by clinical examination and anal sphincter manometry
Description
examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence
Time Frame
1 year
Title
wound healing time
Description
time taken for wound to be completely healed
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Simple non recurrent perianal fistula with ASA I and II. Exclusion Criteria: secondary anal fistula, complex fistula, anal incontinence, previous anal surgery Any disease or drug that affects wound healing.
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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Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain

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