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

Z

Zagazig University

Status

Completed

Conditions

Anal Fistula

Treatments

Procedure: fistulotomy
Procedure: fistulotomy and marsupialization of wound edges

Study type

Interventional

Funder types

Other

Identifiers

NCT04155905
marsupialization anal fistula

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

group A fistulotomy group
Active Comparator group
Description:
35 patients with simple anal fistula subjected to fistulotomy
Treatment:
Procedure: fistulotomy
group B marsupialization group
Active Comparator group
Description:
35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound
Treatment:
Procedure: fistulotomy and marsupialization of wound edges

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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