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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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).
Incidence of severe pain in the post-anaesthesia care unit
Number of operations with NRS \>= 7 divided by the total number of operations.
Secondary outcomes
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.
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.
Sponsors and contacts
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Umeå University
Lead sponsor
Västernorrland County Council, Sweden
Collaborator
The Scandinavian Obesity Surgery Registry
Collaborator