Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Post operative major morbidities and early mortality (<90 day).
研究概览
简要总结
The present study is being designed to study the impact and predictive nature of perioperative hyponatremia on post operative outcomes in patients undergoing Major HPB surgeries for cancers. Major hepatobiliary-pancreatic surgeries will be defined as follows-
- Pancreaticoduodenectomy,
- Hemihepatectomy or greater with or without caudate lobectomy
- Extrahepatic bile duct resection
- Extended cholecystectomy
- Distal Pancreatectomy with or without splenectomy The primary Objective of the study would be to compare post operative major morbidities and early mortality (<90 day) in major HPB surgeries done for cancer patients with and without peri-operative hyponatremia. (<135mmoL/L). Development of systemic complications and long term outcomes (overall survival and disease free survival) will also be evaluated.
It will be an observational study consisting of both, a retrospective arm and a prospective arm. All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024 will be included in the study.
详细描述
Primary objective: To compare post operative major morbidities and early mortality (<90 day) in major HPB surgeries done for cancer in patients with and without peri-operative hyponatremia. (<135mmoL/L)
Secondary objectives: To compare the following in patients undergoing major HPB surgeries for cancer in patients with and without peri-operative hyponatremia (<135mmoL/L)
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Post operative Systemic complications and
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Long term outcomes
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OS- POD1 till death/ last follow up (30th Sep 2024).
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DFS- Surgical resection till first detected recurrence of cancer or last follow up (30th Sep 2024) without recurrence.
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Study design- Observational study- Retrospective and prospective.
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Study period- Data collection will be done from time of ethical clearance till 30th June 2024.
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Intervention - None
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Monitoring and assessment- Clinical profile of the patient and symptoms will be serially followed during the patients post operative OPD visits.
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STATISTICAL ANALYSIS:
- Continuous variables- with Student t test and Mann Whitney U test as appropriate.
- Categorical data - Chi square or Fischer exact test. Besides the above, appropriate analysis will be done at the time of final data analysis.
- Significance will be seen at 5 % level (p<0.05).
- Adequate subgroup analysis and multivariate regression analysis will be done.
- Adverse effects - No adverse effect is expected to occur out of the study protocol.
- Stopping rule - Not Valid
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
- •All patients undergoing major HPB cancer surgeries at ILBS from 2010 till 30th June 2024.
排除标准
- •Presence of diuretic (Thiazide, Frusemide), pain killer (Indomethacin, Ketorolac) induced preoperative hyponatremia.
- •Patients with peri-operative diarrhea and vomiting due to infective cause leading to hyponatremia.
- •Patients who did not have a preoperative serum sodium level recorded within 72 hours prior to surgery.
- •Minor HPB cases.
结局指标
主要结局
Post operative major morbidities and early mortality (<90 day).
时间窗: Post operative day 90
Post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer. in patients with and without peri-operative hyponatremia. (\<135mmoL/L).
次要结局
- Overall Survival(Till 30th Sep 2024)
- Post operative Systemic complications.(Post operative day 90)
- Disease free survival(Till 30th Sep 2024)