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

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.

Study Overview

• Status: Completed
• Conditions: Perianal Fistula
• Intervention / Treatment: Procedure: Non Packing of perianal abscess cavity after drainage; Procedure: Packing of perianal abscess cavity after drainage

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41511
    • Suez Canal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non Packing group; • 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.	Procedure: Non Packing of perianal abscess cavity after drainage; 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.
Other: Packing group; In 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.	Procedure: Packing of perianal abscess cavity after drainage; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perianal fistula formation	To Compare the incidence of fistulous tract formation in patients drained with non-packing vs. packing approach.	6 months
Recurrence of perianal abscess	To Compare the incidence of abscess recurrence formation in patients drained with non-packing vs. packing groups .	6 months

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: Waleed Mostafa Ghareeb, MD, PhD, Suez Canal University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: perianal fistula; perianal abcess
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Infections; Inflammation; Suppuration; Abscess; Fistula
• Other Study ID Numbers: 5697#

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will be available and can be provided by the study investigators on reasonable request according to the regulations of our institute.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No