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

Study Overview
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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.

Official Title
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Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females? An Open Prospective Randomised Study, Comparing Nutritional Preoperative Drink and Chewing Gum During Recovery to Standard Care.

Conditions
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Quality of Recovery

Intervention / Treatment
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* Other: ProvideXtra® Fresenius Kabi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-2 Exclusion Criteria: ASA 3-4, obese

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>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<br>* Improving wellbeeing<br>* Other names: standard consumer xylitol chewing gum;|
| No Intervention: Control<br>control group following standard guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of recovery, PONV, PDNV