Intravenous Fluids After Laparoscopic Cholecystectomy | NCT03142464

Studies
Intravenous Fluids After Laparoscopic Cholecystectomy

NCT03142464

Sponsor

Federal University of Minas Gerais

Status

Completed

Last Update Posted

May 8, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Postoperative Nausea
Postoperative Vomiting
Renal Function Abnormal
Hunger
Thirst
Fluid Electrolyte Disorders

Interventions

Suspension of the IV fluids

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jul 30, 2016Actual

Completion Date

Jul 30, 2016Actual

First Submitted Date

Apr 9, 2017

First Submission Date that Met QC Criteria

May 3, 2017

First Posted Date

May 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2017

Last Update Posted Date

May 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Isabel Toulson Davisson Correia, Professor of Surgery, Federal University of Minas GeraisPrincipal Investigator

Lead Sponsor

Federal University of Minas GeraisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients undergoing elective laparoscopy cholecystectomies were randomized to either routine practice fluid prescription (control group) or no IV fluids in the postoperative period. Thirst, hunger, presence of nausea and vomiting, renal function and personal satisfaction were assessed.

Body composition was evaluated by bioimpedance

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Suspension of the IV fluids	Other	No IV fluids prescription, IV catheter filled with saline solution	No IV fluids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal function	Serum creatinine	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Presence of thirst	Visual analog scale	24 hours
Presence of nausea	Visual analog scale	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

Exclusion Criteria: Co-existing severe renal failure, cardiac failure or pulmonary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided