Early PONV - a Registry Based Study in Sweden.

• Conditions: Postoperative Nausea and Vomiting; Postoperative Complications
• Interventions: Other: no intervention

• Registration Number: NCT04433676
• Lead Sponsor: Jakob Wallden

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.

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 2016-2019) was retrieved from SPOR on June 3 2020 and further analysis and reporting is based on the most updated dataset (yearly basis).

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-14
• Last Update Submitted: 2020-06-14
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with surgical procedures	no intervention	Adult patients undergoing surgical procedures under general or regional anesthesia and with an admission to a recovery unit for the initial postoperative care.

Primary Outcome Measures

Name	Time	Method
PONV	At the recovery unit, up to 24 hours after surgery.	Nausea or Vomiting

Trial Locations

Locations (1)

Västernorrland County Council / Sundsvall Hospital; 🇸🇪 Sundsvall, X, Sweden