Trial Outcomes & Findings for Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery (NCT NCT02213380)

NCT ID: NCT02213380

Last Updated: 2024-05-09

Results Overview

Post-operative delirium diagnosed with Confusion Assessment Method

Recruitment status

COMPLETED

Study phase

Target enrollment

950 participants

Primary outcome timeframe

in 7 days post operation

Results posted on

2024-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Group RA Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA General anesthesia (general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
Underwent Randomization STARTED	476	474
Underwent Randomization COMPLETED	471	471
Underwent Randomization NOT COMPLETED	5	3
Per-protocol Analysis STARTED	471	471
Per-protocol Analysis COMPLETED	439	435
Per-protocol Analysis NOT COMPLETED	32	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Group RA Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA General anesthesia (general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
Underwent Randomization Withdrawal by Subject	2	0
Underwent Randomization Not treated	3	3
Per-protocol Analysis Protocol Violation	32	36

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group GA n=471 Participants General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.	Group RA n=471 Participants Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Total n=942 Participants Total of all reporting groups
Age, Continuous	76.69 years STANDARD_DEVIATION 6.57 • n=471 Participants	77 years STANDARD_DEVIATION 6.5 • n=471 Participants	76.84 years STANDARD_DEVIATION 6.53 • n=942 Participants
Sex: Female, Male Female	352 Participants n=471 Participants	343 Participants n=471 Participants	695 Participants n=942 Participants
Sex: Female, Male Male	119 Participants n=471 Participants	128 Participants n=471 Participants	247 Participants n=942 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI)	21.79 kg/m^2 STANDARD_DEVIATION 3.33 • n=471 Participants	21.71 kg/m^2 STANDARD_DEVIATION 3.48 • n=471 Participants	21.75 kg/m^2 STANDARD_DEVIATION 3.40 • n=942 Participants
Level of education Illiterate	282 Participants n=471 Participants	286 Participants n=471 Participants	568 Participants n=942 Participants
Level of education Elementary school	119 Participants n=471 Participants	124 Participants n=471 Participants	243 Participants n=942 Participants
Level of education Secondary school or above	70 Participants n=471 Participants	61 Participants n=471 Participants	131 Participants n=942 Participants
Type of fracture Femoral neck fracture	264 Participants n=471 Participants	278 Participants n=471 Participants	542 Participants n=942 Participants
Type of fracture Fracture of femoral head	1 Participants n=471 Participants	2 Participants n=471 Participants	3 Participants n=942 Participants
Type of fracture Intertrochanteric	200 Participants n=471 Participants	183 Participants n=471 Participants	383 Participants n=942 Participants
Type of fracture Subtrochanteric	6 Participants n=471 Participants	8 Participants n=471 Participants	14 Participants n=942 Participants
ASA class I	17 Participants n=471 Participants	22 Participants n=471 Participants	39 Participants n=942 Participants
ASA class II	363 Participants n=471 Participants	350 Participants n=471 Participants	713 Participants n=942 Participants
ASA class III	90 Participants n=471 Participants	98 Participants n=471 Participants	188 Participants n=942 Participants
ASA class IV	1 Participants n=471 Participants	1 Participants n=471 Participants	2 Participants n=942 Participants
Mini-mental State Examination	19.59 units on a scale STANDARD_DEVIATION 6.41 • n=471 Participants	19.39 units on a scale STANDARD_DEVIATION 6.27 • n=471 Participants	19.49 units on a scale STANDARD_DEVIATION 6.34 • n=942 Participants
Pre-operative delirium	3 Participants n=471 Participants	5 Participants n=471 Participants	8 Participants n=942 Participants
Comorbidities Respiratory system disease	43 participants n=471 Participants	37 participants n=471 Participants	80 participants n=942 Participants
Comorbidities Central nervous system disease	57 participants n=471 Participants	65 participants n=471 Participants	122 participants n=942 Participants
Comorbidities Urinary system disease	117 participants n=471 Participants	112 participants n=471 Participants	229 participants n=942 Participants
Comorbidities Gastrointestinal system disease	145 participants n=471 Participants	173 participants n=471 Participants	318 participants n=942 Participants
Comorbidities Hematologic system disease	19 participants n=471 Participants	18 participants n=471 Participants	37 participants n=942 Participants
Comorbidities Cardiovascular system disease	300 participants n=471 Participants	280 participants n=471 Participants	580 participants n=942 Participants

PRIMARY outcome

Timeframe: in 7 days post operation

Post-operative delirium diagnosed with Confusion Assessment Method

Outcome measures

Outcome measures
Measure	Group RA n=471 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=470 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Number of Participants With Post-operative Delirium in 7 Days Post Operation	29 Participants	24 Participants

SECONDARY outcome

Timeframe: within fist 7days post operation

Number of participants with delirium includes patients who had delirium in the post in the first 7 post-operative days. The severity of delirium was described using a severity score from 0 (no delirium) to 39 (highest severity) and subtypes of delirium as hyperactive, hypoactive or mixed.

Outcome measures

Outcome measures
Measure	Group RA n=29 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=24 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Number of Participants With Post-operative Delirium 1 episode of POD	16 Participants	10 Participants
Number of Participants With Post-operative Delirium 2 episodes of POD	5 Participants	10 Participants
Number of Participants With Post-operative Delirium >=3 episodes of POD	8 Participants	4 Participants

SECONDARY outcome

Timeframe: within first 7days post operation

The worst severity scores of delirium was diagnosed with the DRS-R-98 within 7 days

Outcome measures

Outcome measures
Measure	Group RA n=29 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=24 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Severity of Delirium	23.48 score on a scale Standard Deviation 7.16	24.22 score on a scale Standard Deviation 7.04

SECONDARY outcome

Timeframe: within first 7 days post operation

The subtypes of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98). Patients with the hyperactive subtype may be agitated, disoriented, and delusional, and may experience hallucinations. This presentation can be confused with that of schizophrenia, agitated dementia, or a psychotic disorder.

Outcome measures

Outcome measures
Measure	Group RA n=29 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=24 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
The Subtypes of Delirium Diagnosed in 7 Days Post Operation No motor	9 Participants	4 Participants
The Subtypes of Delirium Diagnosed in 7 Days Post Operation Hyperactive	16 Participants	16 Participants
The Subtypes of Delirium Diagnosed in 7 Days Post Operation Hypoactive	2 Participants	1 Participants
The Subtypes of Delirium Diagnosed in 7 Days Post Operation Mixed motor	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days after surgery

Population: 6 patients in RA were lost to 30-day follow-up and 24 patients in GA were lost to 30-day follow-up.

Mortality within 30 days post operation

Outcome measures

Outcome measures
Measure	Group RA n=465 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=447 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
30 Day Mortality	8 Participants	4 Participants

SECONDARY outcome

Timeframe: In 7days post operation

The worst pain score within 7 days post-operation in both groups. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 point) to worst pain (100 points).

Outcome measures

Outcome measures
Measure	Group RA n=471 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=470 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Acute Pain Score Using Visual Analogue Scale (VAS)	0 score on a scale Interval 0.0 to 20.0	0 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: till the day of discharge from hospital, an average of 7 days

Length of hospital stay are measured from the anesthesia starting day to the discharge day

Outcome measures

Outcome measures
Measure	Group RA n=471 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=471 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Length of Hospital Stay	7 days Interval 5.0 to 10.0	7 days Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: 1 day after operation

Costs of anesthetic procedure only

Outcome measures

Outcome measures
Measure	Group RA n=471 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=471 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Costs of Anesthetic Procedure	159 dollars Interval 110.0 to 220.0	268 dollars Interval 201.0 to 359.0

SECONDARY outcome

Timeframe: till the day of discharge

Entire expenditure in-hospital

Outcome measures

Outcome measures
Measure	Group RA n=471 Participants Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=471 Participants Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Total In-hospital Costs	5582 dollars Interval 4598.0 to 7362.0	5908 dollars Interval 4778.0 to 7631.0

SECONDARY outcome

Timeframe: 6 months after discharge

Other events: 79 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Group RA n=471 participants at risk Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=471 participants at risk Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Cardiac disorders acute myocardial infarction	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Cardiac disorders acute left heart failure	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Gastrointestinal disorders acute gastric perforation	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Respiratory, thoracic and mediastinal disorders lung infection	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Nervous system disorders stroke	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.

Other adverse events

Additional Information

Ting Li

The second affiliated hospital and Yuying children's hospital of Wenzhou medical university

Phone: 008613587876896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group RA n=471 participants at risk Method of anesthesia: regional anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA	Group GA n=471 participants at risk Method of anesthesia: general anesthesia method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia. General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA. Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
Respiratory, thoracic and mediastinal disorders Hypoxemia	2.3% 11/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	2.8% 13/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Vascular disorders Hypotension	2.8% 13/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	2.1% 10/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Vascular disorders Hypertension	0.85% 4/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	2.8% 13/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Cardiac disorders Arrhythmia	0.64% 3/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.85% 4/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Cardiac disorders Chest distress	0.64% 3/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.42% 2/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Gastrointestinal disorders Nausea and vomiting	10.0% 47/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	7.2% 34/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Gastrointestinal disorders Abdominal pain	0.42% 2/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Gastrointestinal disorders Diarrhea	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Gastrointestinal disorders Acute gastric perforation*	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Nervous system disorders Headache and dizziness	0.42% 2/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.85% 4/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Nervous system disorders Stroke	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
General disorders Numbness in the back	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
General disorders Shiver	2.3% 11/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	2.3% 11/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
General disorders Pharyngodynia	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Skin and subcutaneous tissue disorders Skin allergy	0.85% 4/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Skin and subcutaneous tissue disorders Mild burns of skin	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Nervous system disorders Cerebrospinal fluid leak	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
General disorders Hematoma in neck	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
General disorders Hyperglycaemia	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Renal and urinary disorders Urinary retention	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.
Blood and lymphatic system disorders Anemia	0.00% 0/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.	0.21% 1/471 • Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.