Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females?

NCT ID: NCT03825666

Last Updated: 2019-02-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Abstract One major goal in modern perioperative anaesthesia care is to facilitate a rapid, yet safe recovery process, with focus on improving time to regained consciousness and subsequent resuming of activities of daily living. Laparoscopic cholecystectomy and gynaecological laparoscopy are a "high volume" procedure commonly performed in young females expecting rapid resumption of health.

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.

Methods 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. The Quality of Recovery scale (QoR) 15 items and 5 additional questions around gastro-intestinal symptoms were self-assessed by patients at each occasion.

Conditions

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Quality of Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active

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.

Group Type EXPERIMENTAL

ProvideXtra® Fresenius Kabi

Intervention Type OTHER

Improving wellbeeing

Control

control group following standard guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ProvideXtra® Fresenius Kabi

Improving wellbeeing

Intervention Type OTHER

Other Intervention Names

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standard consumer xylitol chewing gum

Eligibility Criteria

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Inclusion Criteria

* ASA 1-2

Exclusion Criteria

* ASA 3-4, obese
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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EmmaObrink

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Obrink2

Identifier Type: -

Identifier Source: org_study_id

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