Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome (DEHYD)
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|ClinicalTrials.gov Identifier: NCT03788070|
Recruitment Status : Terminated (Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.)
First Posted : December 27, 2018
Last Update Posted : May 19, 2020
|Condition or disease|
|Dehydration Postoperative Nausea and Vomiting Postoperative Complications|
The information about the impact of preoperative dehydration on postoperative outcome is conflicting. One of the reported difficulties of the studies in this field is to get adequate power for statistical significance. The incidence of preoperative dehydration in different surgical populations has been reported in about one third of patients. The prevalence in the urologic population is not known.
This is a monocentric observational study with no study intervention. The goal is to consecutively include all patients undergoing major urologic surgery during 365 days who meet the inclusion criteria to assess the prevalence of preoperative dehydration in elective major abdominal urologic surgery when the standard operation procedures of the University Hospital Bern are applied.
|Study Type :||Observational|
|Actual Enrollment :||188 participants|
|Official Title:||Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome|
|Actual Study Start Date :||February 12, 2019|
|Actual Primary Completion Date :||March 16, 2020|
|Actual Study Completion Date :||March 30, 2020|
- Prevalence of Dehydration at Induction of Anesthesia [ Time Frame: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery ]Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.
- Postoperative Nausea and Vomiting (PONV) [ Time Frame: 6 hours, 24 hours and 48 hours postoperatively ]Number of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively.
- Gastrointestinal function (flatus/defecation) postoperatively [ Time Frame: 24 hours and 48 hours postoperatively ]Time of first flatus or defecation
- Renal function postoperatively [ Time Frame: 6 hours, 24 hours and 48 hours postoperatively ]Creatinine 6, 24 and 48 hours postoperatively.
- Fluid balance [ Time Frame: within 24 hours postoperatively ]Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.
- Complications within hospitalization [ Time Frame: within hospital stay, expected to be within 2 weeks postoperatively ]Number of complications according to a prospective list
- Quality of recovery [ Time Frame: 24 hours postoperatively ]Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150 (0 worst possible, 150 best possible), is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788070
|Inselspital University Hospital Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Lukas M Löffel, M.D.||Inselspital University Hospital Bern|