Clinical trial NCT03788070: Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome
Official title: Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dehydration
Postoperative Nausea and Vomiting
Postoperative Complications
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Dehydration at Induction of Anesthesia
timeFrame: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery
Secondary outcomes:
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 6 hours, 24 hours and 48 hours postoperatively
measure: Gastrointestinal function (flatus/defecation) postoperatively
timeFrame: 24 hours and 48 hours postoperatively
measure: Renal function postoperatively
timeFrame: 6 hours, 24 hours and 48 hours postoperatively
measure: Fluid balance
timeFrame: within 24 hours postoperatively
measure: Complications within hospitalization
timeFrame: within hospital stay, expected to be within 2 weeks postoperatively
measure: Quality of recovery
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital University Hospital Bern
Study officials:
affiliation: Inselspital University Hospital Bern
name: Lukas M Löffel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: