Prediction of Anastomotic Leak/Stricture After Esophagectomy With Gastric Pull-up by Venous Blood Gas
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- The Clavien-Dindo Classification of Surgical Complications
研究概览
简要总结
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures.
The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
The investigators suppose that elevation of acid features of blood (pH decreasing, lactate increasing etc.) as expression of tissue ischemia after gastric tube creation maybe the significant predictive sign for future anastomotic leaks or strictures.
After operation the investigators plan to find relationship between the blood gas changes and rate of anastomotic leak and stricture.
This is prospective study. Anticipated cohort of 50 patients
详细描述
Prediction of Anastomotic Leak/Stricture after Esophagectomy with Gastric Pull-up by Venous Blood Gas.
Esophageal resection becomes a routine surgical procedure in many medical centers. Usually reconstruction after esophagectomy is achieved by gastric pull-up with cervical or intrathoracic anastomosis. The only blood supply for this gastric tube is by right gastroepiploic arcade. Bad or borderline perfusion of gastric tube is the main reason for future anastomotic leaks or strictures.
There are a lot of methods for intraoperative assessment of gastric tube perfusion. This methods include basic (as color, temperature of tube) and advanced assessment as optical fiber spectroscopy, visible light spectroscopy, the combination of a laser Doppler flowmeter and spectrophotometer, a laser Doppler imager, partial tissue oxygen pressure with a Clark-type polar graphic oxygen electrode, continuous measurement of mucosal PCO2 using recirculation gas analysis with a TONOCAP device together with mean arterial pressure measurement, and cardiac output and systemic vascular resistance by pulse contour analysis laser-assisted fluorescent-dye angiography (1-5).
All this methods are comparative complicated and do not promise good assessment results.
The investigators suggest to measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood.
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 scheduled to undergo elective esophagectomy with gastric pull-up reconstruction in Beilinson hospital and are willing and able to give inform consent.
排除标准
- 未提供
结局指标
主要结局
The Clavien-Dindo Classification of Surgical Complications
时间窗: 3 months
Ann of Surg 2009;250: 187-196
Definition and measurement of anastomotic leak
时间窗: 3 months
Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Bruce J1, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Br J Surg. 2001 Sep;88(9):1157-68.
Assessment of anastomotic stricture severity
时间窗: 3 months
Assessment of anastomotic stricture severity by size for minimal (12 mm), mild (9-12 mm), moderate (5-8 mm), or severe (\<5 mm) using endoscopy or Barium esophagram.
Criteria for defining a surgical site infection (SSI)
时间窗: 3 months
Data from: Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection. In: Infection Control and Hospital Epidemiology, CDC 1999; 20:247.
次要结局
未报告次要终点
研究者
Veacheslav Zilbermints
MD
Rabin Medical Center
