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Perianal FistulaNCT06527833

Procedure-Specific Approach To Minimize Fistulaization of The Perianal Abscess Cavity After Surgical Drainage

A study testing Non Packing of perianal abscess cavity after drainage and Packing of perianal abscess cavity after drainage in people with Perianal Fistula, run by Suez Canal 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

Perianal abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Perianal Fistula
What is being tested?
Non Packing of perianal abscess cavity after drainage and Packing of perianal abscess cavity after drainage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteEgypt
Study dates
10 Jul 2024to 31 Jan 2025
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • above 18 years old with
  • perianal abscesses for the first time.

Who cannot join

  • sepsis,
  • Previous pelvic radiation
  • Pregnancy or lactation
  • Immunosuppressive state
  • Malignancy
  • Refusal to participate will be excluded from this study

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Suez Canal University Hospital

    Ismailia, 41511

Other trials in Egypt

About this study

Perianal abscess is a common surgical condition primarily caused by infection of rectal and anal glandular crypts due to non-specific obstruction. Around 10% of cases result from various factors like Crohn's disease, trauma, HIV, STDs, radiation therapy, or foreign bodies. Symptoms include perianal pain, back pain, fever, and more. The main treatment is incision and drainage, but packing during drainage can reduce fistula incidence, though it is associated with pain and cost. Research comparing outcomes with and without packing is limited.

Read the detailed description

Perianal abscess is a common anorectal condition. Most perianal abscesses are due to infection of the glandular crypts of the rectum and anus caused by non-specific obstruction. A small percentage of cases, around 10%, can be attributed to alternative causes such as Crohn's disease, trauma, human immunodeficiency virus, sexually transmitted diseases, radiation therapy, or foreign bodies.

Perianal abscesses are considered one of the most common colorectal pathologies with an estimated annual incidence of around 20,000 people in Egypt. Perianal abscesses are more common in males as compared to females and more in younger males than older. Also, there is an increased risk of anorectal abscess in conditions such as diabetes, and obesity.

Perianal pain is the most common presentation of perianal abscesses, which may increase with defecation, movement, sitting or coughing. Supra-levator abscesses may present with lower back pain or a dull ache in the pelvic region. Patients may also report fever, malaise, rectal drainage, erythema of surrounding skin and possibly urinary retention. The severity of pain can sometimes prevent the clinician from performing a digital rectal examination or anoscopic examination, therefore if the diagnosis is in doubt, an examination under general anaesthesia should be performed.

Anorectal abscesses can spread into the ischiorectal fossa. They can lead to a horse-shoe-shaped collection or track up towards and through the levator musculature, making management more challenging. Perianal fistulae are a common complication of peri-anal abscesses. Fistulae can be classified according to their tract location in relation to the internal and external sphincters as transphincteric fistula, high intersphincteric fistula, suprasphincteric fistula or extra sphincteric fistula.

In the presence of a perianal fistula, imaging modalities such as CT scans help diagnose intraabdominal pathology such as Crohn's disease and detecting air within the fistulous tract and the abscess cavity. However, MRI is the investigation of choice in evaluating secondary extensions from the fistulous tract and differentiating it from nearby pelvic soft tissue structures.

The management of perianal abscesses is incision and drainage. Without adequately eliminating the source of infection, antibiotics will be ineffective. Minimizing the patient's pain, protecting anal sphincter function and reducing the recurrence of anal fistulae is as important as curing the abscess. Packing at the time of abscess drainage, which requires multiple dressing changes per week for several weeks, can be helpful in providing hemostasis of the inflamed, hypervascular abscess cavity.

However, about 40% of patients with perianal abscess subsequently develop fistula after management. Packing is frequently accompanied by postoperative pain and discomfort, slow wound healing, and increased financial burden yet lower rate of incidence of fistula as demonstrated in Pearce study. Also, there is lack of information comparing postoperative outcomes in managing the perianal abscess cavity with packing and with no packing.

Being tested
Non Packing of perianal abscess cavity after drainage, Packing of perianal abscess cavity after drainage
Keywords
perianal abcess, perianal fistula

What participants receive

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

  • Non Packing of perianal abscess cavity after drainageProcedure or surgery

    • All patients will undergo incision and drainage under general anaesthesia.
    • In Group (A [Non-Packing group]), The surgery will be performed by making a cruciate incision over the abscess and incision widened using forceps to allow complete drainage of the cavity containing, without any catheter drainage and packing avoided. The lesion will be left open to heal by secondary intention. The patient was advised to have a sitz bath and apply a dressing over the cavity.
  • Packing of perianal abscess cavity after drainageProcedure or surgery

    an elliptical incision will be made, and the abscess will be fully drained then packing the cavity will be done with sterile gauze with a change of dressing every 24 hours until it is completely healed.

Study groups in NCT06527833
Study groupRoleWhat they receive
Non Packing groupExperimental• In Group (A [Non-Packing group]), The surgery will be performed by making a cruciate incision over the abscess and incision widened using forceps to allow complete drainage of the cavity containing, without any catheter drainage and packing avoided. The lesion will be left open to heal by secondary intension. The patient was advised to have a sitz bath and apply dressing over the cavity.
Receives: Procedure: Non Packing of perianal abscess cavity after drainage
Packing groupOtherIn group (B [Packing group]), an elliptical incision will be made, and the abscess will be fully drained then packing the cavity will be done with sterile gauze with a change of dressing every 24 hours until it is completely healed.
Receives: Procedure: Packing of perianal abscess cavity after drainage

What is being measured

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

  1. Perianal fistula formation

    To Compare the incidence of fistulous tract formation in patients drained with non-packing vs. packing approach.

    Measured: 6 months

  2. Recurrence of perianal abscess

    To Compare the incidence of abscess recurrence formation in patients drained with non-packing vs. packing groups .

    Measured: 6 months

Timeline

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

  1. First posted30 Jul 2024
  2. Study start10 Jul 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Jan 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06527833
Sponsor's protocol ID
5697#
Status last verified
Apr 2025
First submitted
25 Jul 2024
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD will be available and can be provided by the study investigators on reasonable request according to the regulations of our institute.

Questions about this trial

What is this clinical trial studying?

A study testing Non Packing of perianal abscess cavity after drainage and Packing of perianal abscess cavity after drainage in people with Perianal Fistula, run by Suez Canal 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 2 inclusion and 6 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 17 Apr 2025. 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?

Perianal fistula formation (time frame: 6 months). The study lists 2 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 17 Apr 2025.

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