Clinical Trial: Staging System for Chronic Symptomatic Pilonidal Sinus Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach
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 Summary: 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.
Sponsor: Trabzon Numune Training and Research Hospital
Current Primary Outcome: Early wound complications [ Time Frame: up to 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
- 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.
- 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).
- 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 ]
Original Secondary Outcome: Same as current
Information By: Trabzon Numune Training and Research Hospital
Dates:
Date Received: March 5, 2016
Date Started: January 2011
Date Completion:
Last Updated: March 14, 2016
Last Verified: March 2016