The National Tonsil Surgery Register in Sweden
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 11,000
- 试验地点
- 1
- 主要终点
- Patient reported symptom relief
研究概览
简要总结
For the purpose of quality assurance, the Swedish Association for Otorhinolaryngology and Head and Neck surgery has developed several national registers concerning ear, nose and throat care. One of these is the National Tonsil Surgery Registry in Sweden (NTSRS). In NTSRS patients undergoing tonsil surgery for benign indications are included. Data regarding indication, surgical methods and techniques as well as patient reported outcomes measures are collected. The register is designed to facilitate description of clinical activities in a unit and help identify the need of clinical improvement programs. By compiling national data, the register can be used to describe clinical practice in a large national cohort.
详细描述
The National Tonsil Surgery Register in Sweden (NTSRS), started in 1997 as one among several registers, aimed to reinforce quality in the Swedish health care and were revised 2009. Data in the NTSRS are collected through four questionnaires; two are filled in by the ENT-surgeon and two postoperative forms, filled in by the patient or the legal guardian, collecting patient related outcome measures (PROM) 30 respective 180 days after surgery.
In the first surgeon questionnaire age, sex, social security number and indication for surgery (upper airway obstruction, recurrent tonsillitis, chronic tonsillitis, peritonsillar abscess, and systemic complications because of tonsillitis or other) are recorded. This is filled in when surgery is notified.
The second surgeon questionnaire records surgical method (TE, TEA, TT or TTA), surgical instruments used for dissection (cold steel, radiofrequency, diathermy scissors, ultracision or other) and hemostasis method used (injection with epinephrine, unipolar diathermy, bipolar diathermy, ties, suture ligature, radiofrequency, other or "none other than compression with packs"). The questionnaire also records information regarding daycare/inpatient procedure and primary postoperative bleeding. Due to the configuration of the questionnaires and the ambition to cover both inpatient and daycare procedures, primary bleeding is defined as bleeding during hospitalization.
The first patient/caregiver form contains several questions mainly regarding postoperative complications. Any contact with healthcare provider due to postoperative bleeding/pain/infection as well as consequences of the contact; prescribed antibiotics and readmission/return to theatre are reported. Conformity between preoperative information and actual patient experience was is also included in this form.
The final questionnaire that is sent to the second patient/caregiver questionnaire asks for perceived symptom relief after 180 days by choosing one alternative of four statements: My symptoms are gone / My symptoms are almost gone / My symptoms have not disappeared/ My symptoms have worsened.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing benign tonsil surgery in Sweden
排除标准
- •All patients operated with an C- or D0-48 ICD 10 code, indicating not benign diagnoses
结局指标
主要结局
Patient reported symptom relief
时间窗: 6 months postoperative report
The final questionnaire that is sent to the second patient/caregiver questionnaire asks for perceived symptom relief after 180 days by choosing one alternative of four statements: My symptoms are gone / My symptoms are almost gone / My symptoms have not disappeared/ My symptoms have worsened.
次要结局
- Patient reported postoperative bleeding(30 days postoperative report)
研究者
Joacim Stalfors
Register Director
National Tonsil Surgery Register in Sweden