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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03788070
Acronym
DEHYD
Enrollment
188
Registered
2018-12-27
Start date
2019-02-12
Completion date
2020-03-30
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Postoperative Complications, Postoperative Nausea and Vomiting

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.

Interventions

None listed

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Dehydration at Induction of AnesthesiaTime point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic SurgeryNumber of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.

Secondary

MeasureTime frameDescription
Gastrointestinal function (flatus/defecation) postoperatively24 hours and 48 hours postoperativelyTime of first flatus or defecation
Renal function postoperatively6 hours, 24 hours and 48 hours postoperativelyCreatinine 6, 24 and 48 hours postoperatively.
Postoperative Nausea and Vomiting (PONV)6 hours, 24 hours and 48 hours postoperativelyNumber of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively.
Complications within hospitalizationwithin hospital stay, expected to be within 2 weeks postoperativelyNumber of complications according to a prospective list
Quality of recovery24 hours postoperativelyChanges 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.
Fluid balancewithin 24 hours postoperativelyJudged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026