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临床试验/NCT02712970
NCT02712970已完成不适用

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

Trabzon Numune Training and Research Hospital0 个研究点目标入组 367 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
367
主要终点
Early wound complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals with symptomatic pilonidal sinus disease.

排除标准

  • •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.

结局指标

主要结局

Early wound complications

时间窗: 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.

次要结局

  • Primary healing rate(within 3 months)
  • Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)(during surgery)
  • Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)(3 years)
  • 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))

研究者

发起方
Trabzon Numune Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ali GUNER, MD

MD

Trabzon Numune Training and Research Hospital

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