NCT03142464

Brief Summary

Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

April 9, 2017

Last Update Submit

May 5, 2017

Conditions

Postoperative NauseaPostoperative VomitingRenal Function AbnormalHungerThirstFluid Electrolyte Disorders

Keywords

saline solutionlaparoscopycholecystectomyoutcomes

Outcome Measures

Primary Outcomes (1)

  • Renal function

    Serum creatinine

    24 hours

Secondary Outcomes (3)

  • Presence of thirst

    24 hours

  • Presence of nausea

    24 hours

  • Total intravenous prescribed fluids per body weight

    24 hours

Study Arms (2)

IV fluids

NO INTERVENTION

Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description

No IV fluids

EXPERIMENTAL

No IV fluids after the termination of the operation. T

Other: Suspension of the IV fluids

Interventions

Suspension of the IV fluidsOTHER

No IV fluids prescription, IV catheter filled with saline solution

No IV fluids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Controls - convention postoperative IV fluids; intervention arm - no IV fluids postoperative
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

April 9, 2017

First Posted

May 5, 2017

Study Start

July 1, 2015

Primary Completion

July 30, 2016

Study Completion

July 30, 2016

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share