Quality of RecoveryNCT03820479
A Study to Investigate Quality of Recovery up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis
An observational study of Quality of Recovery, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided Apfel-score based PONV care and prophylaxis. 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?
- Protocol
- How many people
- 98 participants
- Where
- 1 siteSweden
- Study dates
- 11 Feb 2019to 15 May 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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
Study population: Female undergoing laparoscopic surgery
Who may be able to join
- ASA class 1-2
Who cannot join
- ASA 4, obese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Investigate Quality of Recovery, the Incidence and Impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis
SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided Apfel-score based PONV care and prophylaxis.
Study period: September 2018- September 2019
Read more
Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV care with strict adherence to PONV guidelines there should be no difference in Quality of Recovery between a high-risk patient and a low-risk patient.
Aim: The aim of the study is to investigate if it is possible to reach no difference in Quality of Recovery (QoR) between a high-risk patient and a low risk patient using Apfel-score based PONV care.
Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7 days.
Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration. Nicotine habits and impact on PONV.
Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and 72h. Quality of Recovery will be assessed up to 7 days after surgery.
Treatment: The females will be given ordinary care after local routines, with strict adherence to PONV guidelines.
Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery in Danderyds Hospital.
Primary outcome variables and examinations: When the QoR 15 reaches base line or better after surgery. Number of times the females experience nausea, retching or vomiting and the impact of emetic symptoms on the QoR.
- Conditions
- Quality of Recovery
- Being tested
- Protocol
- 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.
ProtocolOther
Best practice of protocol
| Study group | Role | What they receive |
|---|---|---|
| Apfel score 1 | Female Receives: Other: Protocol | |
| Apfel score 2 | Female, non smoker Receives: Other: Protocol | |
| Apfel score 3 | Female, non smoker, under 40 years old Receives: Other: Protocol | |
| Apfel score 4 | Female, non smoker, under 40 years old, previous history of PONV Receives: Other: Protocol |
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)
Score, a valid questionnaire to measure quality of recovery, 15 questions, maximum score 150p. VAS scales for each items; 0 bad score, 10 optimal score. Mean values for group, sum score will be compared with parametric tests.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start11 Feb 2019
- Primary completion28 Feb 2024
- Study completion15 May 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 7 Days
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
- NCT03820479
- Sponsor's protocol ID
- DanderydH
- Status last verified
- Oct 2024
- First submitted
- 23 Jan 2019
- Last updated
- 10 Jul 2025
- 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Investigate Quality of Recovery, the Incidence and Impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis
- ClinicalTrials.gov ID
- NCT03820479
- Acronym / sponsor ID
- DanderydH
- Conditions
- Quality of Recovery
- Keywords
- Quality of recovery, PONV, PDNV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 29 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.
SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided Apfel-score based PONV care and prophylaxis.
Study period: September 2018- September 2019
Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV care with strict adherence to PONV guidelines there should be no difference in Quality of Recovery between a high-risk patient and a low-risk patient.
Aim: The aim of the study is to investigate if it is possible to reach no difference in Quality of Recovery (QoR) between a high-risk patient and a low risk patient using Apfel-score based PONV care.
Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7 days.
Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration. Nicotine habits and impact on PONV.
Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and 72h. Quality of Recovery will be assessed up to 7 days after surgery.
Treatment: The females will be given ordinary care after local routines, with strict adherence to PONV guidelines.
Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery in Danderyds Hospital.
Primary outcome variables and examinations: When the QoR 15 reaches base line or better after surgery. Number of times the females experience nausea, retching or vomiting and the impact of emetic symptoms on the QoR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apfel score 1 | – | Other: ProtocolFemale |
| Apfel score 2 | – | Other: ProtocolFemale, non smoker |
| Apfel score 3 | – | Other: ProtocolFemale, non smoker, under 40 years old |
| Apfel score 4 | – | Other: ProtocolFemale, non smoker, under 40 years old, previous history of PONV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female undergoing laparoscopic surgery
Key inclusion criteria (1 listed)
- ASA class 1-2
Key exclusion criteria (1 listed)
- ASA 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 |
|---|---|---|
| ProtocolBest practice of protocol | Other | Apfel score 1, Apfel score 2, Apfel score 3, Apfel score 4 |
Primary outcome
Quality of recovery, QoR15 (Quality of Recovery 15)
Time frame: 7 days
Score, a valid questionnaire to measure quality of recovery, 15 questions, maximum score 150p. VAS scales for each items; 0 bad score, 10 optimal score. Mean values for group, sum score will be compared with parametric tests.
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 10 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Recovery, run by Danderyd Hospital at 1 site in Sweden.
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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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: 7 days). 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 10 Jul 2025.