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Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.
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The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. The hypothesis is that preoperative dehydration leads to more 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.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Dehydration at Induction of Anesthesia | Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color. | Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Nausea and Vomiting (PONV) | Number of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively. | 6 hours, 24 hours and 48 hours postoperatively |
| Gastrointestinal function (flatus/defecation) postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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The project population will be all patients undergoing major urologic surgery at the Department of Urology, Inselspital Bern, meeting the inclusion criteria. The number of participants depends on the amount of surgeries of patients meeting the inclusion criteria taking place during the inclusion period of 365 days.
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| Name | Affiliation | Role |
|---|---|---|
| Lukas M Löffel, M.D. | Inselspital University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital University Hospital Bern | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| D020250 | Postoperative Nausea and Vomiting |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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Time of first flatus or defecation |
| 24 hours and 48 hours postoperatively |
| Renal function postoperatively | Creatinine 6, 24 and 48 hours postoperatively. | 6 hours, 24 hours and 48 hours postoperatively |
| Fluid balance | Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1. | within 24 hours postoperatively |
| Complications within hospitalization | Number of complications according to a prospective list | within hospital stay, expected to be within 2 weeks postoperatively |
| Quality of recovery | 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. | 24 hours postoperatively |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |