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

Quality of Recovery Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825666
• Other study ID #: Obrink2
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2018

Study information

• Verified date: January 2019
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA 1-2

Exclusion Criteria:

• ASA 3-4, obese

Related Conditions & MeSH terms

• Quality of Recovery

Intervention

Other:
• ProvideXtra® Fresenius Kabi
Improving wellbeeing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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