NCT07280962

Brief Summary

Perianal abscess is a common surgical emergency that causes significant pain and discomfort. The standard treatment involves incision and drainage (I\&D) of the abscess cavity, traditionally followed by packing to prevent re-accumulation of pus and to promote healing. However, packing is often painful, requires frequent dressing changes, and increases patient discomfort as well as healthcare costs. Recent studies suggest that leaving the cavity unpacked may result in similar healing outcomes while reducing postoperative pain and shortening the length of hospital stay. This randomized controlled trial aims to compare the outcomes of packing versus no packing of the perianal abscess cavity following I\&D. The study will evaluate postoperative pain using the Visual Analogue Scale at 6, 12, and 24 hours, duration of hospital stay, and the recurrence rate within one month. The findings of this research are expected to guide evidence-based clinical practice by improving patient comfort, reducing hospital burden, and optimizing postoperative care protocols.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 23, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

Perianal abccess

Outcome Measures

Primary Outcomes (1)

  • Post-operative Pain

    Patients was assessed for the post-operative pain by using VAS. VAS is a tool used to assess the intensity of pain in patients. The scoring ranges from 0-10, where 0 is minimum or no pain and 10 is maximum pain.

    24 hours

Secondary Outcomes (1)

  • Recurrence

    1 month

Study Arms (2)

Packing group

ACTIVE COMPARATOR

This group will undergo packing of perianal abccess after the drainage.

Procedure: Packing of perianal abccess with surgical gauze

Non-packing group

PLACEBO COMPARATOR

This group received no packing after drainage of perianal abcess.

Procedure: Non-packing of perianal abccess

Interventions

Patients will undergo packing of perianal abcess after incision and drainage

Packing group

The patients in non-packing group received no packing of wound after drainage of parianal abccess.

Non-packing group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting in the emergency department diagnosed with acute perianal abscess (Diagnosed on the basis of history and clinical examination with ultrasonographic evidence of quantifiable collection and confirmed by needle aspiration of pus from swelling) based on history and examination, requiring incision and drainage.

You may not qualify if:

  • Patients with prior perianal fistulas based on history and examination
  • Patients with recurrent abscess (based on history)
  • Horseshoe abscess as based on examination
  • Previous pelvic irradiation (based on history)
  • Immunocompromised patients
  • Malignant abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Perera AP, Howell AM, Sodergren MH, Farne H, Darzi A, Purkayastha S, Paraskeva P. A pilot randomised controlled trial evaluating postoperative packing of the perianal abscess. Langenbecks Arch Surg. 2015 Feb;400(2):267-71. doi: 10.1007/s00423-014-1231-5. Epub 2014 Jul 23.

    PMID: 25053508BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 15, 2025

Study Start

May 1, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations