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

NCT ID: NCT03788070

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-12

Study Completion Date

2020-03-30

Brief Summary

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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

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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.

Conditions

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Dehydration Postoperative Nausea and Vomiting Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukas M Löffel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Inselspital University Hospital Bern

Locations

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Inselspital University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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LOLD 01-19

Identifier Type: -

Identifier Source: org_study_id

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