Staging System for Chronic Symptomatic Pilonidal Sinus Disease

A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: pit-picking technique; Procedure: Bascom Cleft Lift; Procedure: Rhomboid excision with the Limberg Flap; Procedure: Other flap techniques

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.

• Study Type: Observational
• Enrollment (Actual): 367

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients that were operated because of chronic symptomatic pilonidal sinus disease

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
stage-I; Single pit in the midline, no lateral extension. Pit-picking technique will be performed.	Procedure: pit-picking technique; midline pits were excised removing a minimal amount of tissue (with a margin of skin of <1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures.
Stage-II; >1 pits in the midline, no lateral extension. Pit-picking and Bascom cleft lift techniques will be performed.	Procedure: pit-picking technique; midline pits were excised removing a minimal amount of tissue (with a margin of skin of <1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures.; Procedure: Bascom Cleft Lift; The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.
Stage-III; Midline pit/pits plus lateral extension in one direction. Bascom cleft lift technique will be performed.	Procedure: Bascom Cleft Lift; The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.
Stage-IV; Midline pit/pits plus lateral extension in both directions. Rhomboid excision with the Limberg Flap will be performed.	Procedure: Rhomboid excision with the Limberg Flap; The area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture
Stage-R; Recurrent PSD following any type of treatment. Other flap techniques such as V-Y advancement flap, Z-Plasty will be performed.	Procedure: Bascom Cleft Lift; The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.; Procedure: Rhomboid excision with the Limberg Flap; The area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture; Procedure: Other flap techniques; Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early wound complications	Complications were classified as infection (superficial or deep), collection (seroma or hematoma), wound dehiscence (partial or complete), or anesthesia-related complications. complications will be reviewed from time of surgery to the end of healing. percentage of participants with any wound complication will be evaluated as patients with complication.	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)	Patients will be followed up for recurrence for three years. Total number of patients presenting with recurrence will be evaluated at the end of 3rd year.	3 years
Primary healing rate	All surgical site complications were recorded, and patients with prolonged healing were regularly examined until complete healing was achieved. Primary healing was defined as no breakdown of the wound (complication-free healing) at any point along its length.	within 3 months
Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''	hospital stay for patients in postoperative period will be measured from the day of surgery to the day of discharge (as days).	during first week (one week)
Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)		during surgery

Collaborators and Investigators

• Sponsor: Trabzon Numune Training and Research Hospital
• Collaborators: Karadeniz Technical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 5, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Estimate): March 18, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Cysts; Otorhinolaryngologic Diseases; Nose Diseases; Pilonidal Sinus; Paranasal Sinus Diseases
• Other Study ID Numbers: TrabzonNTRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: because this is retrospective study.