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

NCT06527833 | Completed DMC

• 1 other identifier: 5697#
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Perianal Fistula

Keywords

perianal abcess; perianal fistula

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Non Packing group

EXPERIMENTAL

• 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

Packing group

OTHER

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

Interventions

Non Packing of perianal abscess cavity after drainage PROCEDURE

* 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.

Non Packing group

Packing of perianal abscess cavity after drainage PROCEDURE

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.

Packing group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University Hospital

Ismailia, 41511, Egypt

Location

Study Officials

• Waleed Mostafa Ghareeb, MD, PhD

  Suez canal University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and Lecturer of Surgery

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: July 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)