Intravenous Fluids After Laparoscopic Cholecystectomy

Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Thirst; Postoperative Nausea; Postoperative Vomiting; Hunger; Fluid Electrolyte Disorders; Renal Function Abnormal
• Intervention / Treatment: Other: Suspension of the IV fluids

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: IV fluids; Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description
EXPERIMENTAL: No IV fluids; No IV fluids after the termination of the operation. T	Other: Suspension of the IV fluids; No IV fluids prescription, IV catheter filled with saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function	Serum creatinine	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of thirst	Visual analog scale	24 hours
Presence of nausea	Visual analog scale	24 hours
Total intravenous prescribed fluids per body weight		24 hours

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): July 30, 2016
• Study Completion (ACTUAL): July 30, 2016

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: outcomes; laparoscopy; cholecystectomy; saline solution
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 102908/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No