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

Postoperative Complications Clinical Trial

— DEHYD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03788070
• Other study ID #: LOLD 01-19
• Status: Terminated
• Start date: February 12, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 188
• Est. completion date: March 30, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Vomiting

Locations

Country	Name	City	State
Switzerland	Inselspital University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Gastrointestinal function (flatus/defecation) postoperatively	Time of first flatus or defecation	24 hours and 48 hours postoperatively
Secondary	Renal function postoperatively	Creatinine 6, 24 and 48 hours postoperatively.	6 hours, 24 hours and 48 hours postoperatively
Secondary	Fluid balance	Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.	within 24 hours postoperatively
Secondary	Complications within hospitalization	Number of complications according to a prospective list	within hospital stay, expected to be within 2 weeks postoperatively
Secondary	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