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

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ClinicalTrials.gov Identifier: NCT03788070
Recruitment Status : Terminated (Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.)
First Posted : December 27, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.

Condition or disease
Dehydration Postoperative Nausea and Vomiting 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.

Study Design
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Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 30, 2020

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of Dehydration at Induction of Anesthesia [ Time Frame: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery ]
    Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.


Secondary Outcome Measures :
  1. Postoperative Nausea and Vomiting (PONV) [ Time Frame: 6 hours, 24 hours and 48 hours postoperatively ]
    Number of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively.

  2. Gastrointestinal function (flatus/defecation) postoperatively [ Time Frame: 24 hours and 48 hours postoperatively ]
    Time of first flatus or defecation

  3. Renal function postoperatively [ Time Frame: 6 hours, 24 hours and 48 hours postoperatively ]
    Creatinine 6, 24 and 48 hours postoperatively.

  4. Fluid balance [ Time Frame: within 24 hours postoperatively ]
    Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.

  5. Complications within hospitalization [ Time Frame: within hospital stay, expected to be within 2 weeks postoperatively ]
    Number of complications according to a prospective list

  6. Quality of recovery [ Time Frame: 24 hours postoperatively ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788070


Locations
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Switzerland
Inselspital University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lukas M Löffel, M.D. Inselspital University Hospital Bern
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03788070    
Other Study ID Numbers: LOLD 01-19
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dehydration
Vomiting
Postoperative Complications
Postoperative Nausea and Vomiting
Nausea
 Signs and Symptoms, Digestive
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases