Clinical trial NCT05339828: Unroofing Curettage for Pilonidal Disease
Official title: Unroofing Curettage for Treating Simple and Complex Sacrococcygeal Pilonidal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Disease
Recurrence
Healing Wound
Keywords: complex pilonidal disease
unroofing curettage
recurrence
Lay open technique
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients aged 18 years or older who applied for simple and complex SPD treatment between April 2016 and September 2018 and preferred the UC surgery from all the treatment options offered by the physician.

Brief summary: This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

Detailed description: Sacrococcygeal pilonidal disease (SPD) is a well-known chronic inflammatory condition that affects young adults; There are many treatment options available today, from simple non-surgical methods to extensive flap procedures. However, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself.

While, UC is considered safe and effective for treating simple SPD, its suitability for treating complex disease is poor and controversial. To date, no studies have investigated the efficacy of UC specifically when treating complex SPD.

This is the first study to identify and compare efficacy and outcomes after UC in patients classified into simple and complex SPD groups.

This study was conducted at the Department of Surgery of the Diskapi Training and Research Hospital in Ankara, Turkey. The local ethics committee of the institution approved the study protocol (number 27/02, dated March 22, 2016), and written informed consent was obtained from all participants.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged 18 years or older

Exclusion Criteria:

* acute pilonidal abscess
* poorly controlled
* diabetes mellitus,
* immunosuppressive or coagulation disorders,
* pregnancy and/or lactation,
* other acute surgical diseases

Primary outcomes:
measure: Recurrence
timeFrame: 15 days
Secondary outcomes:
measure: complete healing time
timeFrame: 15 days
measure: VAS pain score
timeFrame: 15 days
measure: time to return to daily activities
timeFrame: 15 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Diskapi Training and Research Hospital
Study officials:
affiliation: Ankara Diskapi Training and Research Hospital
name: Engin Olcucuoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kepenekci I, Demirkan A, Celasin H, Gecim IE. Unroofing and curettage for the treatment of acute and chronic pilonidal disease. World J Surg. 2010 Jan;34(1):153-7. doi: 10.1007/s00268-009-0245-6.
citation: McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and meta-analysis. BMJ. 2008 Apr 19;336(7649):868-71. doi: 10.1136/bmj.39517.808160.BE. Epub 2008 Apr 7.
citation: Karakayali F, Karagulle E, Karabulut Z, Oksuz E, Moray G, Haberal M. Unroofing and marsupialization vs. rhomboid excision and Limberg flap in pilonidal disease: a prospective, randomized, clinical trial. Dis Colon Rectum. 2009 Mar;52(3):496-502. doi: 10.1007/DCR.0b013e31819a3ec0.
citation: Olcucuoglu E, Sahin A. Unroofing curettage for treatment of simple and complex sacrococcygeal pilonidal disease. Ann Surg Treat Res. 2022 Oct;103(4):244-251. doi: 10.4174/astr.2022.103.4.244. Epub 2022 Oct 7.