Prospective Observational Study on Patients Treated for Vertebral Metastasis and Vertebral Localizations of Lymphoproliferative Disease: Impact of the Treatment on the Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Quality of life evaluation
研究概览
简要总结
Perspective observational cohort study in which the data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and surgical treatment candidates will be collected, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute starting from the date of approval of the same study.
Patients of both sexes and aged 18 years or older will be included. Patients with primary (benign or malignant) tumors of the vertebrae and patients unable to consent to the study will be excluded from the study.
For each patient, in addition to the demographic data, preoperative information will be collected: type of tumor, involved vertebral levels, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, neurological picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the quality of life; information related to the intervention itself: access, type of surgical treatment, possible preoperative embolization; intraoperative complications; information at discharge: postoperative complications, pain, neurological picture, functional status; follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late complications, local recurrence; systemic progression of the disease.
Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36 months. The timing of the controls and the examinations requested by the patients will be those of normal clinical practice.
Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and pain (measured using the VAS score) following surgery compared to pre-operative values.
详细描述
STUDY DESIGN Analytical Prospective Longitudinal cohort Not checked
RATIONALE OF THE STUDY The improvement of the systemic control of oncological diseases achieved in recent years has led to a considerable increase in patient survival; it was associated with a parallel increase in the onset of symptomatic vertebral metastases.
Such metastases are often associated with pain, mechanical instability of the spine, and even possible neurological deficits, which negatively affect the patient's quality of life and indirectly also on his survival.
The treatment of these metastases is defined by a multidisciplinary approach; surgery is indicated in the presence of mechanical instability, signs of neurological compression, intractable pain, progression of disease during systemic treatment.
The indication and the type of intervention are defined following a reference algorithm (A. Gasbarrini, M. Cappuccio, L. Mirabile, S. Bandiera, S. Terzi, G. Barbanti Bròdano, S. Boriani.) Spinal Metastases: treatment evaluation algorithm Eur Eur Med Pharmacol Sci 2004; 8: 265-274), in collaboration with the team of specialists involved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who are candidates for surgery at the level of the spine at the SC of Spine Surgery, for: or vertebral metastases or or vertebral localizations from hemolymphoproliferative diseases
- •Patients aged ≥ 18 years
- •Patients giving written informed consent to the study
排除标准
- •Patients with malignant or benign vertebral tumors
- •Patients suffering from vertebral metastases or vertebral localizations from hemolymphoproliferative diseases for which there are no indications for surgical treatment
结局指标
主要结局
Quality of life evaluation
时间窗: At 36 months follow up
EuroQoL- 5D (EQ-5D) patient-administered questionnaire
Health survey
时间窗: At 36 months follow up
Short Form Health Survey 36 (SF-36) patient-administered questionnaire
Pain evaluation
时间窗: At 36 months follow up
Visual Analogue Scale (VAS) patient-administered questionnaire
次要结局
- Prognostic factor- 1(36 months follow up)
- Prognostic factor- 2(36 months follow up)