NCT05193032

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

December 31, 2021

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evolution of the patients, within 2 years

    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 Outcomes (3)

  • Predictive factors for recurrence of abscesses

    Year 2

  • Patient care

    Year 2

  • Cure rate

    Year 2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (8)

  • Quah HM, Tang CL, Eu KW, Chan SY, Samuel M. Meta-analysis of randomized clinical trials comparing drainage alone vs primary sphincter-cutting procedures for anorectal abscess-fistula. Int J Colorectal Dis. 2006 Sep;21(6):602-9. doi: 10.1007/s00384-005-0060-y. Epub 2005 Nov 30.

    PMID: 16317550BACKGROUND
  • Malik AI, Nelson RL, Tou S. Incision and drainage of perianal abscess with or without treatment of anal fistula. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD006827. doi: 10.1002/14651858.CD006827.pub2.

    PMID: 20614450BACKGROUND
  • Sahnan K, Askari A, Adegbola SO, Tozer PJ, Phillips RKS, Hart A, Faiz OD. Natural history of anorectal sepsis. Br J Surg. 2017 Dec;104(13):1857-1865. doi: 10.1002/bjs.10614. Epub 2017 Aug 31.

    PMID: 28857130BACKGROUND
  • Sahnan K, Askari A, Adegbola SO, Warusavitarne J, Lung PFC, Hart A, Faiz O, Phillips RKS, Tozer P. Persistent Fistula After Anorectal Abscess Drainage: Local Experience of 11 Years. Dis Colon Rectum. 2019 Mar;62(3):327-332. doi: 10.1097/DCR.0000000000001271.

    PMID: 30451763BACKGROUND
  • Sho S, Dawes AJ, Chen FC, Russell MM, Kwaan MR. Operative Incision and Drainage for Perirectal Abscesses: What Are Risk Factors for Prolonged Length of Stay, Reoperation, and Readmission? Dis Colon Rectum. 2020 Aug;63(8):1127-1133. doi: 10.1097/DCR.0000000000001653.

    PMID: 32251145BACKGROUND
  • Lohsiriwat V, Yodying H, Lohsiriwat D. Incidence and factors influencing the development of fistula-in-ano after incision and drainage of perianal abscesses. J Med Assoc Thai. 2010 Jan;93(1):61-5.

    PMID: 20196412BACKGROUND
  • He Z, Du J, Wu K, Chen J, Wu B, Yang J, Xu Z, Fu Z, Pan L, Wen K, Wang X. Formation rate of secondary anal fistula after incision and drainage of perianal Sepsis and analysis of risk factors. BMC Surg. 2020 May 6;20(1):94. doi: 10.1186/s12893-020-00762-3.

    PMID: 32375721BACKGROUND
  • Mocanu V, Dang JT, Ladak F, Tian C, Wang H, Birch DW, Karmali S. Antibiotic use in prevention of anal fistulas following incision and drainage of anorectal abscesses: A systematic review and meta-analysis. Am J Surg. 2019 May;217(5):910-917. doi: 10.1016/j.amjsurg.2019.01.015. Epub 2019 Jan 31.

    PMID: 30773213BACKGROUND

Study Officials

  • Amine ALAM

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

March 18, 2022

Primary Completion

September 12, 2022

Study Completion

September 14, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations