Abces After Incision: Recurrence or Not? (ABCINCIS)

March 6, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

The French School of Proctology assumes that any anal or perianal abscess is related to an anal fistula and therefore requires treatment at the risk of recurrence of the abscess. The Anglo-Saxons, on the other hand, recommend a simple incision in case of a first abscess, without taking care of the possible fistula, on the grounds that more than 60% of patients will not have a recurrence of their abscess. In addition, predictive factors of abscess recurrence have been reported such as female gender, age over 40 years, however, contradicted by other studies. High BMI, corticosteroid use, Crohn's disease are other predictive factors of recurrence while diabetes mellitus or antibiotic therapy during the days following the incision were considered as "protective". The objective of this study was to evaluate our experience in the hospital with essentially a description of the evolution of the patients in the 2 years following the incision of the abscess in consultation.

The main objective is to describe the evolution of patients, within 2 years, who consulted our center for an anal or perianal abscess treated by a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients managed at the center for anal or perianal abscesses treated with a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during examination under anesthesia in the operating room, between January 1, 2019 and December 31, 2019

Description

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Patient who visited between January 1, 2019 and December 31, 2019 for an anal or perianal abscess
  • Patient who had a skin incision of a first anal margin or buttock abscess and/or whose fistula was not found during examination under anesthesia in the operating room
  • French speaking patient

Exclusion Criteria:

  • Patient with pilonidal abscess
  • Patient with an intramural abscess
  • Patient with a history of anal margin or buttock abscess and/or anal fistula
  • Patient with a history of proctologic surgery
  • Patient with an abscess whose skin incision under local anesthesia has failed
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his or her data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the patients, within 2 years
Time Frame: Year 2
This outcome corresponds to the rate of occurrence of at least one new abscess, within 2 years, in patients who were treated by a simple skin incision in consultation and/or whose fistula was not found during examination under anesthesia in the operating room.
Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors for recurrence of abscesses
Time Frame: Year 2
This outcome corresponds to the Predictive factors for the occurrence of at least one new abscess, within 2 years, in patients who consulted our center for an anal or perianal abscess treated by a simple skin incision in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.
Year 2
Patient care
Time Frame: Year 2
This outcome corresponds to the Description of the management (imaging, surgical techniques, number of surgical procedures) of patients who were operated on under anesthesia in the operating room and whose fistula was found.
Year 2
Cure rate
Time Frame: Year 2
This outcome corresponds to the Healing and anal incontinence rates of patients who were operated on under anesthesia in the operating room and whose fistula was found.
Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2022

Primary Completion (Actual)

September 12, 2022

Study Completion (Actual)

September 14, 2022

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCINCIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perianal Abscess

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe