Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery (POETRYabd)
2021年2月14日 更新者:Sarah Victoria Ekeløf Busch、Zealand University Hospital
Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study
The aim of the clinical study is:
- to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and major adverse cardiovascular events including myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal surgery.
- to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and non-cardiovascular complications including non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.
- to examine the importance of the postoperative blood glucose level and the pulmonary function for postoperative complications and death within 30, 90 and 365 days of acute abdominal surgery.
- to examine the association between postoperative endothelial function, pulmonary function and blood glucose level
- the qualitative part of the study will examine the postoperative subjective symptoms including acute and chronic pain, quality of recovery and functional status, depressive thoughts and post-traumatic stress disorder.
研究概览
研究类型
观察性的
注册 (实际的)
224
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Køge、丹麦、4600
- Department of Surgery, Zealand University Hospital, Koge
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients undergoing major acute gastrointestinal surgery
描述
Inclusion criteria
- ≥ 18 years old
- Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- Major gastrointestinal surgery on the gastrointestinal tract. This will include
- Open, laparoscopic, or laparoscopically-assisted procedures
- Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
- Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
- Washout/evacuation of intra-peritoneal hematoma
- Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
- Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
- Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
- Laparoscopic/Open Adhesiolysis
- Return to theatre for repair of fascial dehiscence
- Any reoperation/return to theatre meeting the criteria above is included
If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.
Exclusion criteria
- Not capable of giving informed consent after oral and written information
- Previously included in the trial
- If transferred directly from the operation room or recovery ward to the intensive care unit
- Elective laparoscopy
- Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- Appendectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
- Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
- Non-elective hernia repair without bowel resection.
- Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
- Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
- Laparotomy/laparoscopy for esophageal pathology Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The change in reactive hyperemia index assessed by EndoPat
大体时间:The change from 4-24 hours to between day 3 and 5 after surgery
|
The change from 4-24 hours to between day 3 and 5 after surgery
|
|
Major adverse cardiovascular events
大体时间:Within 365 days of surgery
|
|
Within 365 days of surgery
|
Postoperative non-cardiovascular complications
大体时间:Within 365 days of surgery
|
Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min.
Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).
|
Within 365 days of surgery
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Nitric oxide biomarkers
大体时间:4-24 hours after surgery and between postoperative day 3-5
|
4-24 hours after surgery and between postoperative day 3-5
|
Reactive hyperemia index assessed by EndoPat
大体时间:4-24 hours after surgery
|
4-24 hours after surgery
|
Reactive hyperemia index assessed by EndoPat
大体时间:between day 3 and 5 after surgery
|
between day 3 and 5 after surgery
|
Blood Glucose level
大体时间:Postoperative day 1 - 7 (or until discharge)
|
Postoperative day 1 - 7 (or until discharge)
|
Pulmonary function
大体时间:Postoperative day 1 - 7 (or until discharge)
|
Postoperative day 1 - 7 (or until discharge)
|
Readmission
大体时间:Readmissions within 1 year of discharge
|
Readmissions within 1 year of discharge
|
Lengths of stay
大体时间:Lengths of stay from the operation day to discharge, on average 14 days.
|
Lengths of stay from the operation day to discharge, on average 14 days.
|
Lengths of stay in the intensive care unit
大体时间:Lengths of stay from the operation day to discharge from hospital, on average 14 days.
|
Lengths of stay from the operation day to discharge from hospital, on average 14 days.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Postoperative quality of recovery (QoR15)
大体时间:postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
|
QoR15 score
|
postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
|
Numerical rating scale (NRS) pain score
大体时间:postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
|
NRS pain score in rest and at activity
|
postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
|
Post-Traumatic Stress Disorder
大体时间:postoperative day 14, 30, 90 and 365
|
Post-Traumatic Stress Disorder questionnaire
|
postoperative day 14, 30, 90 and 365
|
Depressive thoughts
大体时间:postoperative day 14, 30, 90 and 365
|
Hospital anxiety and depression scale
|
postoperative day 14, 30, 90 and 365
|
Postoperative pain
大体时间:postoperative day 14, 30, 90 and 365
|
Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)
|
postoperative day 14, 30, 90 and 365
|
Functional status
大体时间:postoperative day 14, 30, 90 and 365
|
Activity Assessment Scale
|
postoperative day 14, 30, 90 and 365
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Sarah Ekeloef, MD、Department of Surgery, Zealand University Hospital
- 首席研究员:Jakob Burcharth, MD, Phd.、Department of Surgery, Zealand University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年10月1日
初级完成 (实际的)
2018年11月1日
研究完成 (实际的)
2019年11月1日
研究注册日期
首次提交
2016年12月16日
首先提交符合 QC 标准的
2017年1月3日
首次发布 (估计)
2017年1月5日
研究记录更新
最后更新发布 (实际的)
2021年2月17日
上次提交的符合 QC 标准的更新
2021年2月14日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Acute abdominal surgery的临床试验
-
Oregon Health and Science University未知
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
-
Seoul National University HospitalJohnson & Johnson Medical Companies完全的