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ID
Source
Brief title
Health condition
diabetes mellitus
preoperative
glucose
glycaemic control
suikerziekte
preoperatief
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study will be the number of days at home up to 30 days after surgery (DAH30), which is a single,
pragmatic, patient-centred outcome.
Secondary outcome
Secondary outcomes are preoperative and postoperative blood glucose concentrations, incidence of hyperglycaemia and
hypoglycaemia (glucose >10 mmol/l or <4 mmol/l, respectively) and change from baseline HbA1c, fructosamine, and 1,5-
anhydroglucitol.
Background summary
Poor glycaemic control, indicated by an elevated HbA1c, is correlated to poor postoperative outcome in patients
with diabetes mellitus undergoing surgery. However, improving glycaemic control before surgery has not been
extensively studied so far. We hypothesise that improving glycaemic control, using an individualised approach
guided by a specialised diabetes care nurse, will improve postoperative outcomes, measured as number of days
spent at home in the thirty days after surgery.
In general, this study will provide more insight in the importance of glycaemic control before surgery and its ability
to improve postoperative outcomes.
Study objective
Poor glycaemic control, indicated by an elevated HbA1c, is correlated to poor postoperative outcome in patients with diabetes mellitus undergoing surgery. However, improving glycaemic control before surgery has not been extensively studied so far. We hypothesise that improving glycaemic control, using an individualised approach guided by a specialised diabetes care nurse, will improve postoperative outcomes, measured as number of days spent at home in the thirty days after surgery.
Study design
- Preoperative consultation: blood glucose, HbA1c, fructosamine, 1,5 AG
- Day of surgery: blood glucose, HbA1c, fructosamine, 1,5 AG.
- 30 days after surgery: number of days at home up to 30 days after surgery
Intervention
On the day of preoperative consultation, HbA1c will be measured. Patients with an HbA1c <53 mmol/mol will proceed to surgery
according to standard care. Patients with an HbA1c >=53 mmol/mol will be randomised to an intervention group or control group.
Patients in the intervention group will be contacted by a diabetes care nurse for optimisation of their glycaemic control before
surgery. Patients in the control group will proceed to surgery according to standard care.
Postbus 22660
A.H. Hulst
Amsterdam 1100 DD
The Netherlands
0615222469
a.h.hulst@amc.uva.nl
Postbus 22660
A.H. Hulst
Amsterdam 1100 DD
The Netherlands
0615222469
a.h.hulst@amc.uva.nl
Inclusion criteria
- Diabetes mellitus type 2 (diagnosis at least 3 months prior to pre-operative screening)
- Age 18 - 85 years
- Elective non-cardiac surgery
- Scheduled for surgery at least 7 days from date of screening
- Informed consent
Exclusion criteria
- Bariatric surgery
- Palliative surgery
- Outpatient or day case surgery
- (Potentially) pregnant or breast-feeding
- Unable to communicate in Dutch or English, psychiatric disorder, known therapy incompliance or deemed unfit
by the researchers for another reason
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7288 |
| NTR-old | NTR7497 |
| Other | 67034 : ABR |