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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155905
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hazem Nour Abdellatif, Zagazig University

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

Condition or disease Intervention/treatment Phase
Anal Fistula Procedure: fistulotomy and marsupialization of wound edges Procedure: fistulotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparison between two groups of patients with simple anal fistula subjected to different types of treatment
Masking: Single (Participant)
Masking Description: patients don't know the procedure
Primary Purpose: Treatment
Official Title: Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group A fistulotomy group
35 patients with simple anal fistula subjected to fistulotomy
Procedure: fistulotomy
after defining the fistulous track it was laid open (marsupialization)

Active Comparator: group B marsupialization group
35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound
Procedure: fistulotomy and marsupialization of wound edges
after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\0 sutures




Primary Outcome Measures :
  1. operative time in minutes [ Time Frame: intraoperative ]
    the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization

  2. postoperative pain using visual analogue scale [ Time Frame: 1 week ]
    pain in the postoperative period

  3. postoperative complications measured by clinical examination and anal sphincter manometry [ Time Frame: 1 year ]
    examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence

  4. wound healing time [ Time Frame: 1 year ]
    time taken for wound to be completely healed



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155905


Locations
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Egypt
Zagazig Faculty of Medicine
Zagazig, Sharqya, Egypt, 44519
Sponsors and Collaborators
Zagazig University
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Responsible Party: Hazem Nour Abdellatif, Assistant professor, Zagazig University
ClinicalTrials.gov Identifier: NCT04155905    
Other Study ID Numbers: marsupialization anal fistula
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hazem Nour Abdellatif, Zagazig University:
simple anal fistula
marsupialization
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases