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

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

Sponsors

Lead Sponsor: University Hospital Inselspital, Berne

Source University Hospital Inselspital, Berne
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.

Overall Status Terminated
Start Date February 12, 2019
Completion Date March 30, 2020
Primary Completion Date March 16, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Prevalence of Dehydration at Induction of Anesthesia Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery
Secondary Outcome
Measure Time Frame
Postoperative Nausea and Vomiting (PONV) 6 hours, 24 hours and 48 hours postoperatively
Gastrointestinal function (flatus/defecation) postoperatively 24 hours and 48 hours postoperatively
Renal function postoperatively 6 hours, 24 hours and 48 hours postoperatively
Fluid balance within 24 hours postoperatively
Complications within hospitalization within hospital stay, expected to be within 2 weeks postoperatively
Quality of recovery 24 hours postoperatively
Enrollment 188
Condition
Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Lukas M Löffel, M.D. Principal Investigator Inselspital University Hospital Bern
Location
Facility: Inselspital University Hospital Bern
Location Countries

Switzerland

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym DEHYD
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov