Postoperative Nausea and VomitingSPOR-PONVNCT04433676
Early PONV - a Registry Based Study in Sweden.
An observational study of Postoperative Nausea and Vomiting and Postoperative Complications, run by Jakob Wallden at 1 site in Sweden.
Trial summary
The study is an registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Complications
- How many people
- 1,500,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2016to 31 Dec 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Registry data of patients with surgical procedures under general or regional anesthesia in Sweden 2016-2022.
Who may be able to join
- Procedure under general or regional anaesthesia
- Age >=18 years at the day of the procedure.
Who cannot join
- No entry of the PONV-variable in the SPOR-registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Västernorrland County Council / Sundsvall Hospital
Sundsvall, X, 851 86
Jakob Wallden, M.D. PhD., +46703644392, jakob.wallden@umu.se
Antonio Moraitis, M.D. Ph.D., antonio.moraitis@rvn.se
About this study
Official title: Risk of Early Postoperative Nausea and Vomiting (PONV) - a Study With Data From the Swedish Perioperative Register (SPOR).
The study is an registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV). The study will explore several cohorts (for example a specific procedure) on a national basis, report the risk for early PONV and identify associated factors.
Read the detailed description
The study is a registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV).
Almost all hospitals in Sweden report surgical procedures to SPOR and for the years 2016-2019 there are almost 1.7 million procedures in the registry for patients >18years. Data will be extracted from SPOR on a yearly basis and results will be reported on selected cohorts (time periods and/or type of surgical procedure) during the study period.
There is an option for hospitals to register nausea and vomiting occurring at the recovery unit and submit the data to SPOR. If a hospital choose to use the variable in their dataset, all patients at their unit needs to be registered either with [No_Nausea or Vomiting], [Nausea] or [Nausea or Vomiting]. In the year 2019, more than 50% of procedures under anesthesia in the registry had registration of PONV. The strength with this system is that if a unit uses the variable, all cases will be classified either as "noPONV" or "PONV".
The investigators aim to use the variable PONV at the recovery unit to describe the risk for early PONV and explore associated factors in several cohorts of surgical procedures in Sweden.
The first dataset (2016-2018) was sent to the investigators from the SPOR registry in May 2019 and during the period June 2019- May 2020, the dataset was used to build up a model for the analysis of data with a preliminary report of elective surgeries in Sweden the year 2017.
An updated dataset (all cases 2016-2025) was retrieved from SPOR in June 2026 and further analysis and reporting is based on the most updated dataset (yearly basis until 2029).
- Being tested
- no intervention
- Medical subject headings
- Postoperative Nausea and Vomiting, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with surgical procedures | Adult patients undergoing surgical procedures under general or regional anesthesia and with an admission to a recovery unit for the initial postoperative care. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV
Nausea or Vomiting
Measured: At the recovery unit, up to 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Other
- Enrolment
- 1,500,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jakob Wallden
- Sponsor type
- Other government
- Collaborators
- Umeå University
- Responsible party
- Sponsor-investigator, Jakob Wallden, Västernorrland County Council, Sweden
- Investigators
- Jakob Wallden, MD PhD, Principal investigator, Region Västernorrland (Västernorrland County Council)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433676
- Sponsor's protocol ID
- SPOR-PONV 1.0
- Acronym
- SPOR-PONV
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our dataset includes a large set of registry data, and we are not sure if we legally are allowed to share these data.
Publications
Wallden J, Larsson M, Moraitis A, Ahlqvist S, Cengiz Y, Myrberg T, Nystrom H, Hultin M. Early Postoperative Nausea and Vomiting After Bariatric Surgery: A Study of 8426 Patients from the Swedish Perioperative Registry (SPOR). Obes Surg. 2025 Dec;35(12):5308-5315. doi: 10.1007/s11695-025-08351-0. Epub 2025 Nov 4.
PubMed 41188673
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Early Postoperative Nausea and Vomiting (PONV) - a Study With Data From the Swedish Perioperative Register (SPOR).
- ClinicalTrials.gov ID
- NCT04433676
- Acronym / sponsor ID
- SPOR-PONV / SPOR-PONV 1.0
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500,000 participants (estimated)
- Lead sponsor
- Jakob WalldenOther government
- Collaborators
- Umeå University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Jun 2020 (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 study is an registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV). The study will explore several cohorts (for example a specific procedure) on a national basis, report the risk for early PONV and identify associated factors.
Detailed description
The study is a registry study based on data from the Swedish Perioperative Registry (SPOR) during the years 2016-2022 with the aim to explore the risk for postoperative nausea and vomiting at the recovery unit (early PONV).
Almost all hospitals in Sweden report surgical procedures to SPOR and for the years 2016-2019 there are almost 1.7 million procedures in the registry for patients >18years. Data will be extracted from SPOR on a yearly basis and results will be reported on selected cohorts (time periods and/or type of surgical procedure) during the study period.
There is an option for hospitals to register nausea and vomiting occurring at the recovery unit and submit the data to SPOR. If a hospital choose to use the variable in their dataset, all patients at their unit needs to be registered either with [No_Nausea or Vomiting], [Nausea] or [Nausea or Vomiting]. In the year 2019, more than 50% of procedures under anesthesia in the registry had registration of PONV. The strength with this system is that if a unit uses the variable, all cases will be classified either as "noPONV" or "PONV".
The investigators aim to use the variable PONV at the recovery unit to describe the risk for early PONV and explore associated factors in several cohorts of surgical procedures in Sweden.
The first dataset (2016-2018) was sent to the investigators from the SPOR registry in May 2019 and during the period June 2019- May 2020, the dataset was used to build up a model for the analysis of data with a preliminary report of elective surgeries in Sweden the year 2017.
An updated dataset (all cases 2016-2025) was retrieved from SPOR in June 2026 and further analysis and reporting is based on the most updated dataset (yearly basis until 2029).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with surgical procedures | – | Other: no interventionAdult patients undergoing surgical procedures under general or regional anesthesia and with an admission to a recovery unit for the initial postoperative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Registry data of patients with surgical procedures under general or regional anesthesia in Sweden 2016-2022.
Key inclusion criteria (2 listed)
- Procedure under general or regional anaesthesia
- Age >=18 years at the day of the procedure.
Key exclusion criteria (1 listed)
- No entry of the PONV-variable in the SPOR-registry
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 |
|---|---|---|
| no intervention | Other | Patients with surgical procedures |
Primary outcome
PONV
Time frame: At the recovery unit, up to 24 hours after surgery.
Nausea or Vomiting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 41188673Wallden J, Larsson M, Moraitis A, Ahlqvist S, Cengiz Y, Myrberg T, Nystrom H, Hultin M. Early Postoperative Nausea and Vomiting After Bariatric Surgery: A Study of 8426 Patients from the Swedish Perioperative Registry (SPOR). Obes Surg. 2025 Dec;35(12):5308-5315. doi: 10.1007/s11695-025-08351-0. Epub 2025 Nov 4.
- Individual participant dataSharing planned: Undecided. Our dataset includes a large set of registry data, and we are not sure if we legally are allowed to share these data.
Related trials for Postoperative Nausea and Vomiting
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Jakob Wallden, MD PhD principal investigator
Region Västernorrland (Västernorrland County Council)
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 Postoperative Nausea and Vomiting and Postoperative Complications, run by Jakob Wallden 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 2 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Wallden, MD PhD (0046703644392, jakob.wallden@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (time frame: At the recovery unit, up to 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433676, which also lists 1 linked publication.
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 19 Aug 2026.