Clinical trial NCT02712970: Staging System for Chronic Symptomatic Pilonidal Sinus Disease
Official title: A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Sinus
Lead sponsor: Trabzon Numune Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Karadeniz Technical University
First posted: 2016-03-18
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that were operated because of chronic symptomatic pilonidal sinus disease

Brief summary: A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

Detailed description: The collected data of patients who underwent surgery for the treatment of pilonidal sinus disease prior to June 2011 were analyzed. Following this analysis, a staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. "Pit-picking" technique was performed under local anesthesia on an outpatient basis in stage I and stage IIa patients. For stage IIb and stage III patients, the Bascom Cleft Lift /modified Bascom Cleft Lift techniques were performed. For stage IV patients, the rhomboid excision with the Limberg flap technique was used. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

Eligibility criteria: Inclusion Criteria:

* Individuals with symptomatic pilonidal sinus disease.

Exclusion Criteria:

* \<18 y
* Pilonidal sinus disease which identified incidentally and which presented with acute abscesses were not included to the staging system.
* Patients who were treated without the use of the suggested algorithm were excluded from the analysis.

Primary outcomes:
measure: Early wound complications
timeFrame: up to 3 months
Secondary outcomes:
measure: Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)
timeFrame: 3 years
measure: Primary healing rate
timeFrame: within 3 months
measure: Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''
timeFrame: during first week (one week)
measure: Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)
timeFrame: during surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Guner A, Boz A, Ozkan OF, Ileli O, Kece C, Reis E. Limberg flap versus Bascom cleft lift techniques for sacrococcygeal pilonidal sinus: prospective, randomized trial. World J Surg. 2013 Sep;37(9):2074-80. doi: 10.1007/s00268-013-2111-9.
citation: Guner A, Ozkan OF, Kece C, Kesici S, Kucuktulu U. Modification of the Bascom cleft lift procedure for chronic pilonidal sinus: results in 141 patients. Colorectal Dis. 2013 Jul;15(7):e402-6. doi: 10.1111/codi.12243.
citation: Bascom J, Bascom T. Utility of the cleft lift procedure in refractory pilonidal disease. Am J Surg. 2007 May;193(5):606-9; discussion 609. doi: 10.1016/j.amjsurg.2007.01.008.
citation: Mentes O, Bagci M, Bilgin T, Ozgul O, Ozdemir M. Limberg flap procedure for pilonidal sinus disease: results of 353 patients. Langenbecks Arch Surg. 2008 Mar;393(2):185-9. doi: 10.1007/s00423-007-0227-9. Epub 2007 Sep 22.
citation: Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1.
citation: Kement M, Oncel M, Kurt N, Kaptanoglu L. Sinus excision for the treatment of limited chronic pilonidal disease: results after a medium-term follow-up. Dis Colon Rectum. 2006 Nov;49(11):1758-62. doi: 10.1007/s10350-006-0676-1.
citation: Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.