Quality of RecoveryNCT03825666
Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females?
A study testing ProvideXtra® Fresenius Kabi in people with Quality of Recovery, run by Danderyd Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- ProvideXtra® Fresenius Kabi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2
Who cannot join
- ASA 3-4, obese
About this study
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.
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.
Read the detailed 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.
- Conditions
- Quality of Recovery
- Being tested
- ProvideXtra® Fresenius Kabi
- Keywords
- quality of recovery, PONV, PDNV
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProvideXtra® Fresenius KabiOther
Also called standard consumer xylitol chewing gum
Improving wellbeeing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ProvideXtra® Fresenius Kabi |
| Control | No intervention | control group following standard guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study startJan 2017
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EmmaObrink, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825666
- Sponsor's protocol ID
- Obrink2
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03825666
- Acronym / sponsor ID
- Obrink2
- Conditions
- Quality of Recovery
- Keywords
- quality of recovery, PONV, PDNV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: ProvideXtra® Fresenius KabiIntervention 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. |
| Control | No intervention | –control group following standard guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2
Key exclusion criteria (1 listed)
- ASA 3-4, obese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProvideXtra® Fresenius KabiAlso: standard consumer xylitol chewing gumImproving wellbeeing | Other | Active |
Primary outcome
Quality of recovery, QoR15, (Quality of Recovery 15)
Time frame: 48 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ProvideXtra® Fresenius Kabi in people with Quality of Recovery, run by Danderyd Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery, QoR15, (Quality of Recovery 15) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.