23
This may be the author’s version of a work that was submitted/accepted for publication in the following source: Webster, Joan, Osborne, Sonya, Gill, Richard, Chow, Carina Faran Kalan, Wallin, Siobhan, Jones, Lee, & Tang, Annie (2014) Does preoperative oral carbohydrate reduce hospital stay? A randomized trial. AORN Journal, 99 (2), pp. 233-242. This file was downloaded from: https://eprints.qut.edu.au/60925/ c Consult author(s) regarding copyright matters This work is covered by copyright. Unless the document is being made available under a Creative Commons Licence, you must assume that re-use is limited to personal use and that permission from the copyright owner must be obtained for all other uses. If the docu- ment is available under a Creative Commons License (or other specified license) then refer to the Licence for details of permitted re-use. It is a condition of access that users recog- nise and abide by the legal requirements associated with these rights. If you believe that this work infringes copyright please provide details by email to [email protected] License: Creative Commons: Attribution-Noncommercial-No Derivative Works 2.5 Notice: Please note that this document may not be the Version of Record (i.e. published version) of the work. Author manuscript versions (as Sub- mitted for peer review or as Accepted for publication after peer review) can be identified by an absence of publisher branding and/or typeset appear- ance. If there is any doubt, please refer to the published source. https://doi.org/10.1016/j.aorn.2013.12.003

c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

This may be the author’s version of a work that was submitted/acceptedfor publication in the following source:

Webster, Joan, Osborne, Sonya, Gill, Richard, Chow, Carina Faran Kalan,Wallin, Siobhan, Jones, Lee, & Tang, Annie(2014)Does preoperative oral carbohydrate reduce hospital stay? A randomizedtrial.AORN Journal, 99(2), pp. 233-242.

This file was downloaded from: https://eprints.qut.edu.au/60925/

c© Consult author(s) regarding copyright matters

This work is covered by copyright. Unless the document is being made available under aCreative Commons Licence, you must assume that re-use is limited to personal use andthat permission from the copyright owner must be obtained for all other uses. If the docu-ment is available under a Creative Commons License (or other specified license) then referto the Licence for details of permitted re-use. It is a condition of access that users recog-nise and abide by the legal requirements associated with these rights. If you believe thatthis work infringes copyright please provide details by email to [email protected]

License: Creative Commons: Attribution-Noncommercial-No DerivativeWorks 2.5

Notice: Please note that this document may not be the Version of Record(i.e. published version) of the work. Author manuscript versions (as Sub-mitted for peer review or as Accepted for publication after peer review) canbe identified by an absence of publisher branding and/or typeset appear-ance. If there is any doubt, please refer to the published source.

https://doi.org/10.1016/j.aorn.2013.12.003

Page 2: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

1

Manuscript No: AORN-D-13-00018R2

Title: Does preoperative oral carbohydrate reduce hospital stay? A randomized trial.

Investigators

Prof. Joan Webster, RN, BA. Nursing Director, Research, RBWH, Herston, QLD,

School of Nursing & Midwifery, Griffith University, School of Nursing & Midwifery,

University of Queensland.

Dr Sonya Ranee Osborne, RN, PhD. Senior Lecturer, School of nursing. Block N,

Queensland University of Technology, Kelvin Grove, 4059, QLD. Australia. E-mail

[email protected]

Mr Richard Gill, RN BN. Nurse Unit Manager, Department of Colorectal Surgery,

9AN, Ned Hanlon Bld, RBWH, Butterfield St, Herston, 4029, QLD, Australia. E-mail

[email protected]

Dr Carina Faran Kalan Chow, MBBS, FRACS. Colorectal Surgeon, Royal Brisbane

and Womens Hospital & Mater Hospital. Senior Lecturer, University of Queensland

Address: Surgery & Perioperative Services, Level 8, Ned Hanlon Building, RBWH,

Herston Q 4029 Email: [email protected]. Phone: +61 7 36465353

Page 3: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

2

Siobhan Wallin, BHlthSci, NutrDiet, PhD candidate. Senior Clinical Dietitian

Department of Nutrition and Dietetics, Level 2 The James Maybe Building

RBWH, Herston,4029 QLD. E-mail [email protected]

Phone: +61 7 36467997

Lee Jones, B Sci, PhD Candidate, Statistician, School of Population Health,

University of Queensland. Public Health Building, Level 0, Herston Rd., Herston,

QLD., 4006, Australia , E-mail [email protected].

Annie Tang, RN, BN. Registered Nurse, Department of Colorectal Surgery, 9AN,

Ned Hanlon Bld, RBWH, Butterfield St, Herston, 4029, QLD, Australia. E-mail

[email protected]

Correspondence address: Prof. Joan Webster, level 2, building 34, Royal Brisbane

and Women’s Hospital Herston, 4029 QLD, Australia

Email: [email protected]

Telephone: +61 7 3646 8590

Fax: +61 3646 5832

Funding: The study was funded through a competitive grant from the Royal Brisbane

and Women’s Hospital Research Foundation

Page 4: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

3

Abstract

Background: Carbohydrate-rich fluids are used to improve postoperative

recovery but the effectiveness of the product for reducing length of hospital

stay is uncertain.

Objective: To assess the effectiveness of preoperative loading with

carbohydrates on postoperative outcomes.

Participants: Forty six patients booked for elective colorectal surgery.

Methods: Participants were allocated to a Carbohydrate-rich fluid group or

Usual Care group during their pre-admission clinic visit. The primary outcome

was ‘Time to readiness for discharge’.

Results: Patients in the control group spent on average 4.3 days (95%

confidence interval 3.2 to 5.7) and the Carbohydrate-rich fluid group spent 4.1

days (95% confidence interval 3.2 to 5.4) until the primary outcome was met

(p=0.824).

Conclusion: The safety of preoperative high carbohydrate fluids is supported

but we were unable to confirm or refute the benefit of CHO for shorter

hospital stay following elective colorectal surgery.

Page 5: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

4

Introduction

Surgical fast track pathways, based on work by Kehlet et al (2002), employ a number

of perioperative strategies, which aim to improve postoperative outcomes1. One of the

components of these pathways is the use of preoperative, oral, carbohydrate-rich

nutritional supplement (CHO). These supplements have been shown to counteract

postoperative insulin resistance and stress reactions associated with surgical trauma2

and to improve postoperative recovery3. Preoperative oral CHO appears to be

effective in reducing thirst, hunger and fatigue in the postoperative period4 and in

reducing anxiety preoperatively5. The effect of CHO on postoperative nausea and

vomiting is less clear. One study showed that drinking 800ml of a carbohydrate fluid

on the night before surgery and 400mls 2 hrs prior to surgery reduced nausea and

vomiting in the carbohydrate group following laparoscopic cholecystectomy6.

However, a study in a similar population and using the same pre-operative regimen,

found no differences between groups on any of the measured outcomes, including

nausea and vomiting7. Nor did the product reduce nausea and vomiting in patients

who received the drink before coronary artery surgery8 or thyroidectomy

9.

Although some advantages of using a carbohydrate-rich preoperative beverage have

been demonstrated, there is less information about whether these advantages translate

into improved post-operative clinical outcomes, such as shorter recovery times. For

example, clinicians and hospital administrators are interested in whether pre-loading

with a carbohydrate drink reduces hospital length of stay. Following abdominal

surgery, patients usually remain in hospital until their gastrointestinal function has

been restored, so any treatment which facilitates this function may be useful.

Page 6: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

5

However, in their original paper, Kehlet and colleagues (2002) suggested that the

evidence base for the use of carbohydrate enriched pre-operative drinks to improve

outcomes required further investigation before the intervention could be

recommended1. Since that time, there have been three trials of CHO that have

included gastroenterology patients but their findings are contradictory10-12

. None of

these trials compared ‘usual care’ with the administration of a pre-operative

carbohydrate drink, and one included a heterogeneous population11

, which may have

masked any effects the product may have in a more homogeneous group.

At the Royal Brisbane and Women’s Hospital, a standard protocol exists for fasting

pre-operative patients, which could be easily adapted to include a clear carbohydrate

drink for some patients. This provided an opportunity for an independent, pragmatic

trial to add to the evidence around the use of preoperative CHO. Consequently, the

primary aim of this study was to test if a pre-operative carbohydrate drink would

improve clinical outcomes among gastroenterology patients undergoing elective

bowel surgery.

Methods:

Design:

We used a single-site, parallel-group, randomized controlled trial. The Consolidated

Standards of Reporting Trials (CONSORT 2010) Statement, a method for ensuring

transparent reporting of trials (Figure 1), was used to guide trial design and

reporting13

.

Participants and setting:

The trial was conducted at the Royal Brisbane and Women's Hospital, Brisbane,

Australia (RBWH). All colorectal patients undergoing elective bowel surgery and

Page 7: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

6

who were > 18 years of age were eligible for inclusion. Exclusion criteria included

those who were non-English speaking and who did not have an interpreter; pregnant

women; those unable to consume clear fluids; those with gastrointestinal obstruction,

liver cirrhosis, diabetes mellitus or cognitive impairment; and those who were

receiving corticosteroid treatment exceeding 5 mg/day. We also excluded, participants

enrolled in other trials.

The trial was approved by the Hospital’s Human Research Ethics Committee and was

pre-registered (ACTRN12611000868987). All participants provided written consent.

Intervention

Patients randomized to the intervention arm of the study were asked to drink 800ml of

the CHO between 1900 and 2400 hours on the night before surgery and to have no

solid food from midnight. The beverage is a clear fluid with 50 kcal per 100 ml, 290

mOsm/kg, and a pH of 5.0). In accordance with the RBWH protocol, other clear

fluids were allowed during the night. At 0500 hours on the morning of surgery,

patients were asked to drink a further 200mls of the solution and to record any side-

effects caused by the drink.

Control

Patients randomized to the control arm of the study followed the RBWH protocol, that

is, they were not permitted to take solid food from midnight but could drink clear

fluids up to 0500 hours. Patients in both groups were asked to keep a record of their

fluid intake pre-operatively. Details were recorded on a pre-prepared form, which

sought information about both the quantity and type of fluids consumed.

Randomisation

We used a computer generated randomized list to determine allocation sequence and a

telephone service was used to allocate patients to their group. Randomisation was in a

Page 8: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

7

1:1 ratio between the two study groups. Block randomisation was used with random

variation in block sizes. In trials with relatively small numbers, this process ensures

that an equal number of participants are allocated to each group and that the allocation

to the group is not predictable. The process reduces the potential for allocation bias, or

the opportunity to select particular patients for a one group or the other.

Procedure

Patients were screened, consented and enrolled at the pre admission clinic and then

randomized to either the routine care group (Control) or the CHO group

(Intervention). Baseline demographic and risk factor data were also collected at this

stage. Surgery-related data was retrieved from the operating theatre database and

outcome data recorded prospectively on a pre-prepared outcome data sheet. Patients

were followed until hospital discharge or death and any reason for a delay in

discharge noted.

Post operatively, care was individualised according to the type of surgery but most

patients followed the standard protocol. That is, clear fluids from day one followed by

free fluids, such as milk based drinks, pureed soups etc. on day 2-4 and to a general

diet when tolerated. Some patients, with uneventful surgery, were placed on a rapid

rehabilitation diet, which involved clear fluids and, if tolerated free fluids at the next

meal, followed by a general diet if free fluids were tolerated. No record was kept of

which patients received which approach. All patients go through bed exercises,

supervised by a physiotherapist, on the day after surgery and are mobilised on day

two if their pain is well managed.

Page 9: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

8

Surgeons were unaware of group allocation but the trial was not blinded to patients or

clinical staff. None of the investigators had any conflicts of interest and were not

involved with sponsorship from the product manufacturers. The high carbohydrate

beverage was not donated. The primary outcome was readiness for discharge. This

was assigned by ward staff (not research staff or investigators) and there was no

indication in the medical record to indicate to which arm of the study the patient was

assigned. Consequently, the outcome was blinded to investigators.

Outcome Measures

Primary Outcome

1. Time to readiness for discharge: Time in days (or hours) until all of the

following criteria were met: passing flatus, stool and urine; eating

satisfactorily (75% diet according to the patients ‘Food and Fluid

Consumption Chart’); managing on oral analgesics; afebrile; mobilising

independently to shower and toilet; requiring wound dressing changes less that

twice daily; without drains requiring inpatient management.

Secondary Outcomes

1. Time to first flatus

2. Time to first bowel movement

3. Mortality: death from any cause whilst on the trial

4. Adverse outcomes (such as re-admission, aspiration, any reaction or side

effects caused by the drink).

Sample Size and study power

Page 10: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

9

The primary endpoint in this study was time to readiness for discharge. We based our

sample size calculation on the results of a small study10

that showed a mean reduction

of 2.5 days in patients having colorectal surgery. To show such a difference with 80%

power at p=0.05 we required 27 participants in each arm. We intended to inflate this

by an additional three patients per arm (60 patients in all) to allow for any drop outs

or missing data. We did not have any useful data on which to base a sample size

calculation for secondary outcomes.

Statistical methods

All patients for whom outcome data were available were analysed in their allocated

treatment groups (i.e. intention to treat). To reduce the effect of outliers and skewness

within the data, continuous outcome variables were logarithmically transformed and

analysed using t-tests. Geometric means and 95% confidence intervals were reported.

Categorical outcome measures were analysed with chi-squared; Fisher’s exact test

was used when expected cell counts became small. All study outcomes were analysed

using a two-sided P-value of less than .05 to indicate statistical significance. Data was

analysed using IBM SPSS Statistics 19. (IBM Corporation, 2010)

Results

Between August 2011 and April 2012, 74 potentially eligible patients were screened

for inclusion. Forty six of these patients consented and were enrolled in the trial; 22 in

the CHO group and 24 in the Control group. One patient from the Control group did

not have surgery before the trial enrolment period finished, so was excluded. One

additional patient, also in the Control group, remained in hospital for an extended

period, almost eight weeks. He failed to reach our primary outcome of ‘readiness for

discharge’ before he was transferred, so was not included in the outcome analysis.

Other reasons for exclusion are shown in Figure 1. Over half (26; 59.0%) of the

Page 11: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

10

enrolled participants were oncology patients, 18 (40.9%) were male; 37 (84.1%) had

laparoscopic surgery and 4 (9.1%) had surgery under epidural anaesthesia. Other

baseline data, by group, is shown in Table 1.

None of the patients reported side-effects from consuming the CHO beverage but four

did not drink the product before surgery, reasons for this are shown in Figure 1.

Patients in the CHO group drank larger quantities of fluid overall than those in the

control group (CHO 2393ml, SD 1165; Control group 1320ml, SD 982; p = 0.002).

Outcomes

There was no difference in the mean time to readiness for discharge with patients in

the control group on average spending 4.3 days and the CHO group spending 4.1

days until this outcome was met (t=0.224, p=0.824). Nor were differences

demonstrated until passage of first flatus; the control group average was 49.8 hours

compared to 34.7 hours in the CHO group (t=1.551, p=0.129). Although the time to

first bowel movement, on average was shorter in the CHO group (46.5 hours)

compared with the control group (68.4 hours), the result was not statistically different

(t=1.784, p=0.082). Table 2 shows the unadjusted results and Table 3 shows results

adjusted for length of surgery and time from last fluid intake.

Adverse outcomes

Overall, 4 (18%) patients in the control group had an adverse event compared with 2

(9%) in the CHO group, the difference was not statistically significant (Fisher’s exact,

p=0.376). None of these events were related to the intervention and occurred at

various times in the post surgical period. In the control group there was one wound

Page 12: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

11

dehiscence in a patient admitted for repair of an enterocutaneous fistula; one episode

was reported of an airway obstruction, which occurred in the Post Anaesthetic Care

Unit (PACU) following an open anterior resection in a patient with sleep apnoea; one

patient was retuned to theatre for division of adhesions and formation of an ileostomy

eight days after an ileo-anal anastomosis; and one patient with multiple comorbidities,

who had a hemi-colectomy, died two days after the surgery. In the intervention group,

a patient who had an anterior resection and ileostomy was retuned to theatre for

insertion of a urinary stent; and one morbidly obese patient with an anterior resection

was admitted post operatively to the Intensive Care Unit, following an upper airway

obstruction in the PACU.

Discussion

This is the fourth study to investigate the effect of preoperative loading with an oral,

carbohydrate-rich nutritional supplement on length of stay in elective colorectal

patients. The intervention had no effect on our primary outcome, time to readiness

for discharge. Time to first flatus and to first bowel movement were shorter, though

not statistically so, in the intervention group. Theoretically, such a reduction could be

due to a shorter time between ingestion of carbohydrates and surgery. It is well

understood that starvation changes the body’s metabolism, including increased insulin

resistance and reduced muscle function2. However, although those in the intervention

group ingested a higher volume of fluid than those in the control group, they did not

have a longer starvation period.

This raises important issues about our preoperative policy, which allows patients to

eat until midnight and to have no fluid after 05.00hrs. Delays to surgery frequently

occur and, in our case, the average time between the last fluid intake and surgery was

Page 13: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

12

approximately eight hours. This delay is well outside recommendations from decades

of research and recent guidelines, which state that drinking clear fluids up to 2-hours

before elective surgery is safe and beneficial14, 15

.

Strengths and weaknesses of the study

The robust design, use of a ‘usual care’ group that allowed a realistic comparison

between the intervention and control and the ability to follow-up all but two

participants, were important features of the study. Although over one-third of

potentially eligible patients were excluded before randomisation, for only two of these

was the reason because the potential participant refused consent, making future, larger

trials feasible.

Recruiting participants some weeks before the date of surgery introduces the potential

for post-randomisation loss, due to surgical cancellations or patients receiving

treatment elsewhere. Nevertheless, only one patient was lost in this way, even though

in some cases there was up to two months between recruitment and surgery. In

addition, having ‘readiness to discharge’ as the primary end point may also be a

limiting factor if patients are very ill. In our case however, only one patient failed to

meet one or more components of the end point before being discharged, almost eight

weeks after surgery.

One important limitation to the study was the sample size. We based our sample size

on a mean reduction of 2.5 days in time to readiness for discharge. At the time of

planning, this reduction was drawn from results of the only available study10

. The

actual difference in time to readiness for discharge in our study was less than one day;

Page 14: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

13

consequently our study was seriously underpowered to show a difference in the

primary outcome. As a result we are unable to draw conclusions about the

effectiveness or not of the intervention. In addition, because we were constrained by

hospital policy, the intervention was unable to be administered as recommended. than

recommended. So, essentially, the study compared clear fluids with high carbohydrate

fluids. The delay between last ingestion of fluid and surgery may also have impacted

on the study outcomes.

Despite these limitations, there are now four trials assessing the effectiveness of CHO

on hospital length of stay. These trials provide an opportunity for a systematic review

and meta-analysis to enable a clearer picture to be formed about whether CHO

confers any benefit to patient undergoing colorectal surgery. Effect estimates from

any such review would also allow investigators to calculate a more realistic sample

size for any future trial.

Differences between this and other studies

In this study the effect of preoperative carbohydrate loading on readiness to discharge

is inconclusive. Our results are at variance with results from a small trial where 35

participants undergoing colectomy or resection were divided into three groups (pre-

operative water drink, pre-operative fasting and preoperative carbohydrate drink)10

.

Time to readiness for discharge in this study was statistically shorter in the

carbohydrate group when compared with the water group but not when compared

with the fasting group. However, our results concur with the two other trials to have

used hospital length of stay as an outcome11,12

. In the first of these trials, 162 patients

undergoing colorectal surgery or liver resections were randomly allocated to either an

oral carbohydrate drink or a placebo taken the evening before and two hours prior to

surgery. Outcomes of the 142 patients whose results were analysed included

Page 15: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

14

postoperative fatigue, total length of hospital stay and time to ‘fit for discharge’. No

differences between groups were found for any of these outcomes11

. In the second

trial, one of the three interventions was oral intake of 400mls of CHO on the evening

before and on the morning of surgery. Length of hospital stay was assessed but no

between group differences were demonstrated12

. Our population was very similar to

both of these trials and our control and intervention groups well matched for all risk

factors, as was the Mathur (2010) 11

and the Kaska (2010) trials12

. It was unclear if

this was the case in the Noblett (2005) trial, which found a benefit for preoperative

carbohydrate loading10

.

The effectiveness of enhanced preoperative nutrition has also been recently evaluated

in a Cochrane Review. Although the review demonstrated shorter length of stay

among those receiving enhanced nutrition, the authors included studies evaluating any

nutritional intervention, delivered by any route (parenteral, enteral or oral) for

extended periods prior to surgery. Consequently, results from the review are not

comparable with those from the current study16

. Similarly, trials were available where

high carbohydrate drinks were administered as a component of a fast-track protocol17

.

However, because the individual effect of CHO could not be estimated, comparisons

with our results were not possible.

As with other studies in similar populations, no adverse events related to the trial

product were observed 10-12

and there were no anaesthetic complications.

Implications for practice

Until larger, independent trials provide evidence of benefit, use of high carbohydrate

fluids to improve patient outcomes cannot be recommended.

Implications for research

Page 16: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

15

Independent, well designed, pragmatic trials are required to establish if pre-operative,

high carbohydrate fluids provide any meaningful postoperative benefit. Any such trial

should include an economic analysis, be suitably powered to detect clinically

important differences and provide an assessment of patient preferences.

Conclusion

The safety of preoperative high carbohydrate fluids is confirmed but we are unable to

confirm or refute the benefit of CHO for shorter hospital stay.

Page 17: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

16

References

1. Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am

J Surg . 2002;183:360-41

2. Ljungqvist O. Modulating postoperative insulin resistance by preoperative

carbohydrate loading. Best Pract Res Clin Anaesthesiol. 2009;23:401-9.

3. Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J. Adherence

to the enhanced recovery after surgery protocol and outcomes after colorectal

cancer surgery. Arch Surg. 2011;146:571-7.

4. Yagmurdur H, Gunal S, Yildiz H, Gulec H, Topkaya C. J Res Med Sci. The

effects of carbohydrate-rich drink on perioperative discomfort, insulin response

and arterial pressure in spinal aesthesia.2011;16:1483-9.

5. Hausel J, Nygren J, Lagerkranser M. et al. A carbohydrate-rich drink reduces

preoperative discomfort in elective surgery patients. Anesth Analg. 2001;93:1344-

50.

6. Hausel J, Nygren J, Thorell A, Lagerkranser M, Ljungqvist O. Randomized

clinical trial of the effects of oral preoperative carbohydrates on postoperative

nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2005;92:415-

21.

7. Bisgaard T, Kristiansen VB, Hjortsø NC, Jacobsen LS, Rosenberg J, Kehlet H.

Randomized clinical trial comparing an oral carbohydrate beverage with placebo

before laparoscopic cholecystectomy. Br J Surg. 2004;91:151-8.

8. Jarvela K, Maaranen P, Sisto T. Pre-operative oral carbohydrate treatment before

coronary artery bypass surgery. Acta Anaesthesiol Scand. 2008;52:793-7

Page 18: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

17

9. Lauwick SM, Kaba A, Maweja S, Hamoir EE, Joris JL. Effects of oral

preoperative carbohydrate on early postoperative outcome after thyroidectomy.

Acta Anaesthesiol Belg. 2009;60:67-73.

10. Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-

operative oral carbohydrate loading in colorectal surgery: a randomized controlled

trial. Colorectal Dis. 2006;8:563-9.

11. Mathur S, Plank LD, McCall JL. et al. Randomized controlled trial of preoperative

oral carbohydrate treatment in major abdominal surgery. Br J Surg. 2010;97:485-

94.

12. Kaska M, Grosmanová T, Havel E, Hyspler R, Petrová Z, Brtko M. et.al. The

impact and safety of preoperative oral or intravenous carbohydrate administration

versus fasting in colorectal surgery--a randomized controlled trial.Wien Klin

Wochenschr. 2010 Jan;122(1-2):23-30

13. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010

statement: updated guidelines for reporting parallel group randomized trials. Int J

Surg. 2011;9:672-7.

14. Smith I, Kranke P, Murat I. et al. Perioperative fasting in adults and children:

guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol.

2011;28:556-69.

15. ASoA. Practice guidelines for preoperative fasting and the use of pharmacologic

agents to reduce the risk of pulmonary aspiration: application to healthy patients

undergoing elective procedures: an updated report by the American Society of

Anesthesiologists Committee on Standards and Practice Parameters.

Anesthesiology. 2011;114:495-511.

Page 20: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

19

Potentially eligible

Colorectal patients undergoing elective bowel surgery and who were >

18 years of age

(n = 74)

Reasons for exclusion (n = 28)

Unable to drink large quantities (n = 5)

Diabetic (n = 7)

Taking cortisone (n = 6)

Enrolled in another trial (n = 2)

Missed (n = 5)

Refused consent (n = 2)

Other (n = 1)

EN

RO

LM

EN

T

AL

LO

CA

TIO

N

AN

AL

YS

IS

FO

LL

OW

- U

P

Randomized

(n = 46)

Allocated to CHO group

(n = 22)

Allocated to the control

group

(n = 24)

Number included in

outcome analysis

N = 22

Number included in

outcome analysis

N = 22

Number of protocol violations = 4

Nausea = 2

Asleep = 1

Surgery date changed, no high

carbohydrate drink available for

second date = 1

Number of protocol violations = 0

All patients in the Control group

received standard care

Post randomization exclusion (n = 0) Post randomization exclusion (n = 2)

Surgery cancelled (n = 1)

Extended hospital stay (n = 1)

Figure 1. Flow of participants through the trial

Page 21: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

20

Table 1. Characteristics of study population. Values are numbers (percent) of

patients or mean [standard deviation].

CHO group Control group

age in years 54.5 [36.0, 79.0] 61.0 [27.0, 77.0]

Male 8/22 (36.4) 10/22 (36.4)

weight in kilos 69.3 [47.8, 142.6] 76.1[48.0, 97.7]

ASA Grade > 2 5/22 (22.7) 3/22 (13.6)

Oncology patient 12/22 (54.5) 14/22 (63.6)

Epidural anaesthesia 2/22 (9.1) 2/22 (9.1)

Time between last fluid intake and

surgery (in hours)

5.1 [3.1, 26.9] 6.8 [3.4, 16.7]

Duration of surgery (in hours) 3.1 [0.4, 7.2] 3.2[0.9, 8.0]

Laparoscopic surgery 19/22 (86.4) 18/22 (81.8)

Type of surgery

Anterior resection 11/22 (50.0) 7/22 (31.8)

Hemicolectomy 3/22 (13.6) 2/22 (9.1)

Restoration of continuity 5/22 (22.7) 8/22 (36.4)

Sigmoid colectomy 1/22 (4.5) 0/22 (0.0)

Total colectomy 1/22 (4.5) 1/22 (4.5)

Proctectomy and pouch 1/22 (4.5) 3/22 (13.6)

Other surgery 6/22 (27.2) 9/22 (40.9)

N.B. Total sum of types of surgery is greater than 22 in each group; some patients had

more than one type of surgery.

Page 22: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

21

Table 2: Unadjusted outcome variables*

Group mean 95% CI t p-

value lower upper

Time to readiness

for discharge (days)

Control

group

(n = 21) a

4.3 3.2 5.7 0.224 0.824

CHO group

(n = 22)

4.1 3.2 5.4

Time to fist

flatus (hours)

Control

group

(n = 22)

49.8 33.4 74.2 1.551 0.129

CHO group

(n = 22)

34.7 26.0 46.1

Time to first

bowel movement

(hours)

Control

group

(n = 22)

68.4 50.6 92.5 1.784 0.082

CHO group

(n = 21) b

46.5 33.2 65.2

* Outcome variables were logarithmically transformed and geometric means and

confidence intervals are shown

a One patient died before discharge

b Time of bowel movement not recorded for one patient

Page 23: c Consult author(s) regarding copyright matters License · 2020-06-22 · pre-registered (ACTRN12611000868987). All participants provided written consent. Intervention Patients randomized

Preoperative oral carbohydrate

22

Table 3: Outcome variables adjusted by duration of surgery and time to last

fluid *

* Outcome variables were logarithmically transformed and geometric means and

confidence intervals are shown

a One patient died before discharge

b Time of bowel movement not recorded for one patient

Group mean 95% CI F p-value

lower upper

Time to readiness

for discharge (days)

Control group

(n = 21)a

4.4 3.3 5.7 0.106 0.746

CHO group

(n = 22)

4.1 3.2 5.3

Time to fist

flatus (hours)

Control group

(n = 22)

50.1 35.5 70.5 2.468 0.124

CHO group

(n = 22)

34.5 24.7 48.2

Time to first

bowel movement (hours)

Control group

(n = 22)

68.8 50.6 93.6 3.349 0.075

CHO group

(n = 21) b

46.2 33.7 63.4