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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02712970
Enrollment
367
Registered
2016-03-18
Start date
2011-01-31
Completion date
2015-06-30
Last updated
2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Sinus

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.

Interventions

PROCEDUREpit-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.

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.

PROCEDURERhomboid 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

PROCEDUREOther flap techniques

Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty

Sponsors

Karadeniz Technical University
CollaboratorOTHER
Trabzon Numune Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Early wound complicationsup to 3 monthsComplications 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.

Secondary

MeasureTime frameDescription
Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)3 yearsPatients 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.
Primary healing ratewithin 3 monthsAll 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.
Hospital stay The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''during first week (one week)hospital stay for patients in postoperative period will be measured from the day of surgery to the day of discharge (as days).
Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)during surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026