The Causes of Heterotopic Ossification in Abdominal Incision After Pancreatic Surgery：A Single-center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence of HOAI
研究概览
简要总结
To investigate whether pancreatic cancer is the cause of heterotopic ossification of abdominal incision.
详细描述
Heterotopic ossification of abdominal incision (HOAI) has long been regarded as a rare complication after general surgery. However,according to our retrospective analysis. HOAI was more frequently observed in the malignancy group (33/121 cases, 27.3%) than in the non- malignancy group. Because of the many biases in the retrospective analysis, the result was not widely shared.
The purpose of this prospective study is to confirm that pancreatic cancer is the cause of heterotopic ossification of abdominal incisions. According to postoperative pathology, the patients were divided into two groups: pancreatic cancer group and benign diseases group.The researchers will observe whether patients develop heterotopic ossification of the abdominal incision one year after surgery to conclude.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtain informed consent from the patients.
- •The patient's abdominal incision was double-closed with continuous suture of linea alba and fascia with absorbable suture, and skin was sutured with skin staples.
排除标准
- •Refusing to join the study
- •Previous history of malignant tumor
- •Previous history of midabdominal incision
- •Abnormal calcium and phosphorus metabolism
- •Distant metastasis
- •Palliative operation
- •performing neoadjuvant chemotherapy
结局指标
主要结局
Incidence of HOAI
时间窗: 12 months
HOAI is determined by CT, whose CT number is similar to that of the same spine.
Bone alkaline phosphatase
时间窗: 12 months
Preoperative tests were performed and every three months postoperatively
次要结局
- Incidence of distant metastasis and local recurrence(12 months)
研究者
Yi Miao, Prof.
Director of Pancreas Center
Nanjing Medical University