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NCT Number: NCT04215718

Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula

comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula

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Key information

Age range

18 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fistulotomy and marsupialization

Procedure

the anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\\0 sutures

fistulectomy and wound closure

Procedure

anal fistula was excised with both openings and the wound was closed

Primary outcomes

  1. healing time

    Time frame: 8 weeks

    time taken for complete epithelialization of the wound detected by clinical examination

  2. number of participants with recurrence of anal fistula

    Time frame: 6 months

    presence of anal fistula after complete wound healing detected by clinical examination

  3. number of participants with anal incontinence

    Time frame: i months

    inability to control stool or flatus diagnosed by Vaizey score questionaire

Secondary outcomes

  1. number of participants with postoperative pain and its degree

    Time frame: 1 week

    degree of postoperative pain detected by visual analogue scale calculation

  2. number of participants with post operative complications

    Time frame: 1 week

    post operative complications as bleeding and wound infection detected by clinical examination

  3. operative time

    Time frame: 1 hour

    time of the procedures calculated in minutes starting with the first incision to the start of wound dressing

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula, a Comparative Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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