Anal AbscessABCINCISNCT05193032
Abces After Incision: Recurrence or Not?
An observational study of Anal Abscess and Perianal Abscess, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Abscess, Perianal Abscess
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2022to 14 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his or her data for this research
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anal Abscess, Perianal Abscess
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 2
Secondary outcomes (3)
Predictive factors for recurrence of abscesses
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.
Measured: Year 2
Patient care
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.
Measured: Year 2
Cure rate
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.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start18 Mar 2022
- Primary completion12 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anal AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amine ALAM, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193032
- Sponsor's protocol ID
- ABCINCIS
- Acronym
- ABCINCIS
- Status last verified
- Mar 2023
- First submitted
- 31 Dec 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16317550Malik 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;2010(7):CD006827. doi: 10.1002/14651858.CD006827.pub2.
PubMed 20614450Sahnan 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.
PubMed 28857130Sahnan 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.
PubMed 30451763Sho 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.
PubMed 32251145Lohsiriwat 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.
PubMed 20196412He 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.
PubMed 32375721Mocanu 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.
PubMed 30773213
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abces After Incision: Recurrence or Not?
- ClinicalTrials.gov ID
- NCT05193032
- Acronym / sponsor ID
- ABCINCIS / ABCINCIS
- Conditions
- Anal Abscess, Perianal Abscess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Predictive factors for recurrence of abscesses
Time frame: Year 2
Patient care
Time frame: Year 2
Cure rate
Time frame: Year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 16317550Quah 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.
- Background: PubMed 20614450Malik 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;2010(7):CD006827. doi: 10.1002/14651858.CD006827.pub2.
- Background: PubMed 28857130Sahnan 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.
- Background: PubMed 30451763Sahnan 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.
- Background: PubMed 32251145Sho 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.
- Background: PubMed 20196412Lohsiriwat 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.
- Background: PubMed 32375721He 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.
- Background: PubMed 30773213Mocanu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amine ALAM principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Abscess and Perianal Abscess, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the patients, within 2 years (time frame: Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193032, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.