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Completed

NCT Number: NCT02712970

Staging System for Chronic Symptomatic Pilonidal Sinus Disease

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pit-picking technique

Procedure

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.

Bascom Cleft Lift

Procedure

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.

Rhomboid excision with the Limberg Flap

Procedure

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

Other flap techniques

Procedure

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

Primary outcomes

  1. Early wound complications

    Time frame: up to 3 months

    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.

Secondary outcomes

  1. Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)

    Time frame: 3 years

    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.

  2. Primary healing rate

    Time frame: within 3 months

    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.

  3. Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''

    Time frame: 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).

  4. Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)

    Time frame: during surgery

Sponsors and collaborators

Lead sponsor

Trabzon Numune Training and Research Hospital

Other Gov

Collaborators

  • Karadeniz Technical University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Mar 18, 2016
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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