NCT04433676

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

7 years

First QC Date

June 10, 2020

Last Update Submit

June 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • PONV

    Nausea or Vomiting

    At the recovery unit, up to 24 hours after surgery.

Study Arms (1)

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.

Other: no intervention

Interventions

Patients with surgical procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Registry data of patients with surgical procedures under general or regional anesthesia in Sweden 2016-2022.

You may qualify if:

  • Procedure under general or regional anaesthesia
  • Age \>=18 years at the day of the procedure.

You may not qualify if:

  • No entry of the PONV-variable in the SPOR-registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Västernorrland County Council / Sundsvall Hospital

Sundsvall, X, 851 86, Sweden

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postoperative Nausea and VomitingPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Jakob Wallden, MD PhD

    Region Västernorrland (Västernorrland County Council)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Wallden, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer, Consultant Anesthesiologist

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

January 1, 2016

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations