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OpenTrials
Completed

NCT Number: NCT05193032

Abces After Incision: Recurrence or Not?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ABCINCIS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2022
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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