A study on the effect of information on the use of analgesics in patients after weight loss surgery.

NUBS (NSAID Use after Bariatric Surgery): A randomized controlled intervention study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25083

Enrollment

240

Registered

2012-10-15

Start date

2012-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bariatric surgery

Interventions

The intervention is performed by sending a letter to patients and their family doctors belonging to the intervention group, with information about the risks of use of NSAIDS by patients after bariatri

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who underwent bariatric surgery in Medisch Centrum Leeuwarden (MCL) in the period March to November 2011; 2. Patients who signed and turned in a written informed consent.

Exclusion criteria

Exclusion criteria: Patients with no medication record at any moment of the study.

Design outcomes

Primary

Measure	Time frame
The percentage of users of NSAIDS in the period 6 months before the intervention and in the period 3 to 9 months after the intervention in comparison with the control group. The use is determined by collecting dispensing data from pharmacies 6 months before the intervention and 9 months after the intervention. The use of NSAIDS is to be considered as stopped if there is no use of an NSAID any more in the period 3 to 9 months after the intervention.	—

Measure

Time frame

The percentage of users of NSAIDS in the period 6 months before the intervention and in the period 3 to 9 months after the intervention in comparison with the control group. The use is determined by collecting dispensing data from pharmacies 6 months before the intervention and 9 months after the intervention. The use of NSAIDS is to be considered as stopped if there is no use of an NSAID any more in the period 3 to 9 months after the intervention.

—

Secondary

Measure	Time frame
The number of Defined Daily Doses (DDDS) of an NSAID in the period 6 months before the intervention and in the period 3 to 9 months after the intervention in comparison to the control group. The number of DDDS is determined by means of the amount of NSAIDS dispensed in the period 6 months before and 3 to 9 months after the intervention. The intervention is to be considered effective, if the mean number of DDDS of an NSAID in the period 3 to 9 months after the intervention is reduced by half in comparison with the mean number of DDDS of an NSAID in the period 6 months before the intervention. The number of users of NSAIDS with no concurrent use of a PPI in the period 6 months before the intervention and in the period 3 to 9 months after the intervention in comparison to the control group. There is concurrent use of a PPI with an NSAID if the period of use of a PPI has a ¡Ý 2/3 overlap with the period of use of an NSAID. The use is determined by collecting dispensing data from pharmacies 6 months before and 9 months after the intervention. The intervention is to be considered effective if the number of users of NSAIDS with no concurrent use of a PPI is reduced by half in the period 3 to 9 months after the intervention in comparison with the period 6 months before the intervention.	—

Measure

Time frame

The number of Defined Daily Doses (DDDS) of an NSAID in the period 6 months before the intervention and in the period 3 to 9 months after the intervention in comparison to the control group. The number of DDDS is determined by means of the amount of NSAIDS dispensed in the period 6 months before and 3 to 9 months after the intervention. The intervention is to be considered effective, if the mean number of DDDS of an NSAID in the period 3 to 9 months after the intervention is reduced by half in comparison with the mean number of DDDS of an NSAID in the period 6 months before the intervention. The number of users of NSAIDS with no concurrent use of a PPI in the period 6 months before the intervention and in the period 3 to 9 months after the intervention in comparison to the control group. There is concurrent use of a PPI with an NSAID if the period of use of a PPI has a ¡Ý 2/3 overlap with the period of use of an NSAID. The use is determined by collecting dispensing data from pharmacies 6 months before and 9 months after the intervention. The intervention is to be considered effective if the number of users of NSAIDS with no concurrent use of a PPI is reduced by half in the period 3 to 9 months after the intervention in comparison with the period 6 months before the intervention.

—

Contacts

Public ContactJ.P. Yska

Medisch Centrum Leeuwarden Henri Dunantweg 2

j.p.yska@znb.nl+31 (0)58 2866604

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)