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 ]

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.


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