Postoperative Nausea, Vomiting and Pain After Bariatric Surgery - a National Registry Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University

About this trial

Around 4,000-5,000 bariatric (weight-loss) operations are performed in Sweden every year. Nausea, vomiting and pain are common immediately after these operations, cause considerable suffering and increase the intensity and length of hospital care. Bariatric surgery is one of the procedures with the highest risk of postoperative nausea and vomiting (PONV): about one third of patients experience PONV already in the recovery unit, and registry data indicate that around 40% report severe pain at the same stage.

This study links two national quality registries - the Swedish Perioperative Register (SPOR) and the Scandinavian Obesity Surgery Registry (SOReg) - to describe how often adult patients experience nausea, vomiting and pain in the post-anaesthesia care unit after primary bariatric surgery, and to identify patient, anaesthetic and surgical factors associated with these outcomes. The study tests whether total intravenous anaesthesia, the addition of a regional nerve block, and preoperative health-related quality of life are associated with PONV and pain, and whether early PONV or pain is associated with complications, unplanned hospital care or reoperation up to one year after surgery. The results are intended to show how well current evidence on preventing PONV and pain is applied in everyday practice and where care can be improved.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Primary bariatric surgery registered in SOReg during 2018-2027

Disqualifiers

Revision bariatric surgery

If more than one bariatric operation is registered for the same patient, only the primary operation is included

Trial population

All adult patients registered in the Scandinavian Obesity Surgery Registry (SOReg) with a primary bariatric procedure during 2018-2027 and a matching operation record in the Swedish Perioperative Register (SPOR).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

30,000 Participants
are grouped into 1 trial group
Group A: Adults undergoing primary bariatric surgery in Sweden 2018-2027

Trial outcomes

Primary outcomes

1

Incidence of postoperative nausea and/or vomiting in the post-anaesthesia care unit

Number of operations with registered nausea and/or vomiting in the PACU divided by the total number of operations. Source: SPOR variable "Illamående postoperativt" (postoperative nausea).

Time frame
During the stay in the post-anaesthesia care unit (approximately 0-4 hours after surgery)
2

Pain intensity in the post-anaesthesia care unit, numerical rating scale (NRS) 0-10

Median NRS score (0 = no pain, 10 = worst imaginable pain). Source: SPOR variables "Smärta inom 1 tim efter ankomst UVA" (pain within 1 hour of PACU arrival) and "Smärta postoperativt, högsta" (highest postoperative pain).

Time frame
During the stay in the post-anaesthesia care unit (approximately 0-4 hours after surgery)
3

Incidence of severe pain in the post-anaesthesia care unit

Number of operations with NRS \>= 7 divided by the total number of operations.

Time frame
During the stay in the post-anaesthesia care unit (approximately 0-4 hours after surgery)

Secondary outcomes

1

Proportion of patients with postoperative complications, unplanned hospital care or reoperation - 6 weeks

Complications (including Clavien-Dindo grade), unplanned hospital care and reoperation as registered in SOReg at the 6-week follow-up.

Time frame
Up to 6 weeks after surgery
2

Proportion of patients with postoperative complications, unplanned hospital care or reoperation - 1 year

Complications (including Clavien-Dindo grade), unplanned hospital care and reoperation as registered in SOReg at the 1-year follow-up.

Time frame
Up to 1 year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Västernorrland County Council, Sweden

Collaborator

The Scandinavian Obesity Surgery Registry

Collaborator