The Impact of Laparoscopic Versus Open Surgeries on the Incidence of Postoperative Deep Vein Thrombosis in Patients With Gastrointestinal Malignancy ---A Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- the incidence of DVT
研究概览
简要总结
Deep vein thrombosis (DVT) is a common complication of surgery, which could result in pulmonary embolism (PE). PE is a serious and potentially life-threatening syndrome. The purpose of this study is to investigate the impact of laparoscopic versus open surgeries on the incidence of postoperative DVT in patients with gastrointestinal malignancy
详细描述
Compared with open surgery (OS), the laparoscopic surgery (LS) can conduct less invasion, less pain and decrease the rate of wound infection and probably improve the quality of life for patients. For these benefits, laparoscopic surgery was widely used for gastrointestinal surgery. DVT is a common complication of surgery. However, whether LS can reduce the incidence of postoperative DVT is unclear. So the investigators conduct a cohort study, with a sufficient sample size in a rigorous scientific overview, to investigate the impact of laparoscopic versus open surgeries on the incidence of postoperative DVT in patients with gastrointestinal malignancy.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statements.
This study is designed as a cohort study to investigate the incidence of postoperative DVT in patients undergoing gastrointestinal malignancy laparoscopic surgery (group LS) and open surgery (group OS).
Participants in group LS will receive laparoscopic gastrointestinal malignancy surgery.
Participants in group OS will receive open gastrointestinal malignancy surgery. All participants will receive unified post-operative analgesia and the prophylaxis of infection and thromboembolism.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosed with gastrointestinal malignancy
- •aged from 18 to 75 years old
- •woman or man
- •classification of American Society of Anesthesiologists is I to III
排除标准
- •patients with rectal tumor need to resect anus
- •tumor distant metastasis
- •patients with palliative surgery
- •diagnosed with DVT pre-operation
- •body mass index ≤18 or ≥30
- •coagulation dysfunction
- •cerebral hemorrhage history pre-operation
- •hepatorenal dysfunction
- •being pregnant
- •mental disorder
- •patients with peritonitis or uncontrolled general infection
结局指标
主要结局
the incidence of DVT
时间窗: within 7 days postoperatively
DVT will be measured by color Doppler ultrasonography
次要结局
- incidence of incision infection(within 7 days postoperatively)
- time to basic recovery(within 7 days postoperatively)
- concentration of plasma D - dimer 2(1,3,5,7 days postoperatively)
- incidence of lung infection(within 7 days postoperatively)
研究者
Min Su
Department of Anesthesiology and Pain Medicine
First Affiliated Hospital of Chongqing Medical University