NCT03825666

Brief Summary

The aim of this study was to assess whether it was possible to improve patients' self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery. Patients were randomised to an active group receiving the intervention, and controls provided with standard care only. Patients were followed by questionnaire interviews preoperatively and at 2, 24 and 48 hours after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 23, 2019

Last Update Submit

January 31, 2019

Conditions

Quality of Recovery

Keywords

quality of recoveryPONVPDNV

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery, QoR15, (Quality of Recovery 15)

    Quality of recovery after laparoscopic surgery with a valid questionnaire. 15 questions, max point 150. 0 worse, 10 best score. Mean sum is going to be compared.

    48 hours

Study Arms (2)

Active

EXPERIMENTAL

Intervention with drink pre surgery and chewing gum post surgery. No subgroups, combined intervention will be assessed. ProvideXtra® Fresenius Kabi plus standard consumer xylitol chewing gum.

Other: ProvideXtra® Fresenius Kabi

Control

NO INTERVENTION

control group following standard guidelines

Interventions

ProvideXtra® Fresenius KabiOTHER

Improving wellbeeing

Also known as: standard consumer xylitol chewing gum
Active

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2

You may not qualify if:

  • ASA 3-4, obese

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
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 31, 2019

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share