Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome (DEHYD)

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Complications; Dehydration; Postoperative Nausea and Vomiting

Detailed Description

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
• Enrollment (Actual): 188

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • InselSpital University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• >18 years old
• Major elective urologic surgery i. Prostate surgery ii. Bladder surgery iii. Kidney surgery iv. Various laparotomies / laparoscopies (e.g. retroperitoneal lymphadenectomy)
• Standard procedure planned
• Standard perioperative management planned
• Informed consent

Exclusion Criteria:

• Preoperative iv-fluids
• Pregnancy (which is a contraindication to this type of surgery per se)
• Inability to give informed consent (e.g. severe psychiatric disorder, dementia)
• Inability to complete the Quality of Recovery (QoR) questionnaire
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Lukas M Löffel, M.D., InselSpital University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Signs and Symptoms, Digestive; Water-Electrolyte Imbalance; Nausea; Vomiting; Postoperative Complications; Dehydration; Postoperative Nausea and Vomiting
• Other Study ID Numbers: LOLD 01-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No