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Fistula in AnoNCT04215718

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

A study testing fistulotomy and marsupialization and fistulectomy and wound closure in people with Fistula in Ano, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula Read more about this study

Who is it for?
Ages 18 days and older
Conditions the study is for
Fistula in Ano
What is being tested?
fistulotomy and marsupialization and fistulectomy and wound closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteEgypt
Study dates
1 Apr 2017to 31 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • patients above 18 years diagnosed with simple non recurrent anal fistula.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Zagazig Faculty of Medicine

    Zagazig, Sharqya, 44519

Other trials in Egypt

About this study

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

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

Read the 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.

Conditions
Fistula in Ano
Being tested
fistulotomy and marsupialization, fistulectomy and wound closure
Keywords
fistula in ano, fistulectomy wound closure, fistulotomy wound marsupialization
Medical subject headings
Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fistulotomy and marsupializationProcedure or surgery

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

  • fistulectomy and wound closureProcedure or surgery

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

Study groups in NCT04215718
Study groupRoleWhat they receive
fistulotomy groupActive comparator46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges
Receives: Procedure: fistulotomy and marsupialization
fistulectomy groupActive comparator46 patients with simple anal fistula underwent fistulectomy and closure of the wound
Receives: Procedure: fistulectomy and wound closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. healing time

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

    Measured: 8 weeks

  2. number of participants with recurrence of anal fistula

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

    Measured: 6 months

  3. number of participants with anal incontinence

    inability to control stool or flatus diagnosed by Vaizey score questionaire

    Measured: i months

Secondary outcomes (3)
  1. number of participants with postoperative pain and its degree

    degree of postoperative pain detected by visual analogue scale calculation

    Measured: 1 week

  2. number of participants with post operative complications

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

    Measured: 1 week

  3. operative time

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

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start1 Apr 2017
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04215718
Sponsor's protocol ID
anal fistula wound
Status last verified
Jan 2020
First submitted
29 Dec 2019
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing fistulotomy and marsupialization and fistulectomy and wound closure in people with Fistula in Ano, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

healing time (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

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