Clinical trial NCT06378918: Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the PiLOnidal Sinus
Official title: PILO - Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the PiLOnidal Sinus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pilonidal Cyst
Keywords: Pilonidal Cyst
abcess
puncture
incision
intergluteal groove
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-04-23
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence.

An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov.

The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage.

Detailed description: This is a single-center, prospective, open-label, randomized study. Patients are screened and included during the emergency room consultation or a scheduled consultation. After verification of the selection criteria and provision of clear, fair and appropriate information, patients are offered to participate in the study. If they accept, consent is signed and randomization is carried out.

The procedure under study is puncture/aspiration. Local anesthesia is previously carried out with 2-5 cc of 1% lidocaine. The puncture is then carried out using a 16 gauge needle. Antibiotic coverage will be offered. A work stoppage is recommended until the day after the puncture/aspiration but the duration is left to the discretion of the surgeon. The patient is systematically reviewed 15 days after the puncture/aspiration with a recommendation for earlier consultation in the event of persistence of redness, discharge, pain or onset of fever. If these symptoms recur or persist, it is recommended to make an incision with packing. In the event of fistulization following the puncture, associated with discharge and skin necrosis, local nursing care is recommended. The definitive resection procedure is then planned 4 to 6 weeks after the puncture/aspiration if the evolution is favorable.

The gold standard procedure is incision of the abscess. This is carried out according to the habits of the department: in the operating room under general or local anesthesia or in consultation (or emergencies) under local anesthesia. The procedure is carried out on an outpatient basis but, if necessary, short-term hospitalization is carried out. Daily wicking is then carried out with nursing care at home until healing. A work stoppage is recommended for a period of approximately 10 days. The patient is systematically reviewed at 15 days with a recommendation for earlier consultation in the event of persistence of redness, discharge, pain or onset of fever. If these symptoms recur or persist, it is recommended to make an incision with packing. The definitive resection procedure is then planned 4 to 6 weeks after the initial operation if the evolution is favorable.

The definitive resection procedure is carried out after the flattening of the abscess has healed. It is recommended to perform resection without closure with nursing-care healing at home with daily packings for 15 days. After the 15-day visit, changing the dressings by wicking is recommended daily until healing.

Eligibility criteria: Inclusion Criteria:

* Adult patients with a pilonidal sinus abscess
* Surgical indication for flattening the abscess
* Recurrent or de novo abscess
* Signature of consent to participate in the study

Exclusion Criteria:

* Antibiotic therapy initiated before the emergency room consultation or before the scheduled consultation
* Skin necrosis
* Immunosuppression (drug-related or pathological) or diabetes
* Spontaneous fistulization
* Patients who do not speak French
* Pregnant and/or breastfeeding women
* Patients without social security coverage
* Person deprived of liberty by judicial or administrative decision
* Person subject to psychiatric care under duress
* Person subject to a legal protection measure
* Person unable to express consent

Primary outcomes:
measure: healing time
timeFrame: within 6 weeks before resection
Secondary outcomes:
measure: Effectiveness of the 2 procedures
timeFrame: 4 weeks
measure: Cost-utility analysis
timeFrame: 1.5 months and 10 months
measure: Duration of nursing care
timeFrame: within 6 weeks before resection
measure: Duration of work stoppage
timeFrame: within 6 weeks before resection
measure: Returning to work
timeFrame: within 6 weeks before resection
measure: Quality of life by the EQ-5D-5L questionnary
timeFrame: within 10 months
measure: Healing after definitive resection
timeFrame: 3 months after definitive resection
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital of Angers
name: Aurélien VENARA, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Segre D, Pozzo M, Perinotti R, Roche B; Italian Society of Colorectal Surgery. The treatment of pilonidal disease: guidelines of the Italian Society of Colorectal Surgery (SICCR). Tech Coloproctol. 2015 Oct;19(10):607-13. doi: 10.1007/s10151-015-1369-3. Epub 2015 Sep 16.
citation: Doll D, Friederichs J, Boulesteix AL, Dusel W, Fend F, Petersen S. Surgery for asymptomatic pilonidal sinus disease. Int J Colorectal Dis. 2008 Sep;23(9):839-44. doi: 10.1007/s00384-008-0476-2. Epub 2008 May 20.
citation: Doll D, Friederichs J, Dettmann H, Boulesteix AL, Duesel W, Petersen S. Time and rate of sinus formation in pilonidal sinus disease. Int J Colorectal Dis. 2008 Apr;23(4):359-64. doi: 10.1007/s00384-007-0389-5.
citation: Fahrni GT, Vuille-Dit-Bille RN, Leu S, Meuli M, Staerkle RF, Fink L, Dincler S, Muff BS. Five-year Follow-up and Recurrence Rates Following Surgery for Acute and Chronic Pilonidal Disease: A Survey of 421 Cases. Wounds. 2016 Jan;28(1):20-6.
citation: Hussain ZI, Aghahoseini A, Alexander D. Converting emergency pilonidal abscess into an elective procedure. Dis Colon Rectum. 2012 Jun;55(6):640-5. doi: 10.1097/DCR.0b013e31824b9527.
citation: Lasithiotakis K, Aghahoseini A, Volanaki D, Peter M, Alexander D. Aspiration for acute pilonidal abscess-a cohort study. J Surg Res. 2018 Mar;223:123-127. doi: 10.1016/j.jss.2017.09.051. Epub 2017 Nov 17.