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NeutrophilNCT05301985

Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications

A study testing preoperative nutrition in people with Neutrophil and Lymphocyte, run by Nermina Rizvanović at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated the impact of a preoperative carbohydrate oral drink on the postoperative Neutrophil / Lymphocyte Ratio (NLR) and the incidence of postoperative complications after elective open colon surgery compared to the conventional preoperative fasting protocol. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
preoperative nutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBosnia and Herzegovina
Study dates
4 May 2020to 20 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • participants with diagnosed colorectal carcinoma scheduled for elective open colorectal surgery
  • aged between 18 years and 70 years
  • participants with ASA physical status class I-III

Who cannot join

  • previous treatment of colon, rectum or any other cancer
  • emergency or palliative colon and rectum surgery
  • disseminated malignant disease
  • body mass index below 20 and above 30 kg/mᶺ2
  • overall score ≥3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002)
  • disease with increased risk of aspiration
Show all 16Show fewer
  • history of diabetes mellitus
  • history of hematological disease
  • evidence of systemic inflammation
  • immunomodulatory therapy
  • neuromuscular disease
  • pregnancy
  • mental disease
  • allergy to any study drugs
  • alcoholic or drug abuse
  • patient's refusal to participate in the study.

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site

  • Cantonal Hospital Zenica

    Zenica, 72 000

Other trials in Bosnia and Herzegovina

About this study

Official title: Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications Following Colorectal Cancer Surgery: a Randomized Controlled Study

This study evaluated the impact of a preoperative carbohydrate oral drink on the postoperative Neutrophil / Lymphocyte Ratio (NLR) and the incidence of postoperative complications after elective open colon surgery compared to the conventional preoperative fasting protocol. Hypothesis was: preoperative carbohydrate loading reduces postoperative NLR value and reduces the incidence and severity of postoperative complications in colorectal surgery.

Read the detailed description

This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Surgery at the Cantonal Hospital Zenica, Bosnia and Herzegovina. The study protocol was approved by the local Ethics Committee.

A total of 60 participants who scheduled for elective open colon surgery and fulfilled study criteria were included into study. The purpose and procedures of the study were fully explained and voluntary, informed, written consent was obtained from each participant. The participants were randomly allocated into two equal groups, depending on the preoperative treatment. There were no reliable published data for effects of preoperative carbohydrate loading on postoperative NLR values. Based on our hypothesis, a pilot study was performed with ten patients per group. Mean postoperative NLR value was 8,67±4,98 in the participants with a conventional preoperative fasting protocol versus 4,76±2,83 in the participants with preoperative carbohydrate loading. Sample size was estimated using sample size calculator software and power analysis with 95% confidence interval and power of 80%. Statistical significance was considered as p< 0,05. The calculation indicated 27 participants per group would be sufficient to detect a difference of 3,91 with a standard deviation of 4,93 in NLR value between the groups. Assuming dropout of 10%, 30 participants per group were included. Block randomization was used with a block size of six and a 1:1 group ratio. A computer-generated random numbers indicating preoperative intervention, were sealed in opaque envelopes. An investigator who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the surgeons, nurses, anesthesiologists and staff involved in data collection.

The participants in the Fasting group (control group) stopped oral intake at 12:00 pm the night before surgery and underwent to a conventional preoperative fasting protocol. Participants in the Carbohydrate group (experimental group) consumed 400 ml of a clear carbohydrate solution at 10:00 pm the night before surgery and 200 ml of a clear carbohydrate solution, 2 hours prior induction of anesthesia. All participants underwent general anesthesia followed by colorectal surgery.

Fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day. White blood counts were analysed with automated differential counts. The NLR value was obtained by dividing the absolute neutrophil count and the absolute lymphocyte count. All participants were followed up to 30 days post-surgery to assess postoperative complications and readmission rate. After discharge, participants were called by phone, once a week. Postoperative complications were graded for incidence and severity using the Clavien-Dindo Classification of Surgical Complications.

Demographic and surgical data of the participants were recorded: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, nutritional status of the participants according to Nutritional Risk Screening 2002 (NRS-2002), tumor localization and duration of surgery.

Being tested
preoperative nutrition
Keywords
fasting, carbohydrate, colorectal carcinoma, nutritional status
Medical subject headings
Postoperative Complications, Fasting, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • preoperative nutritionDietary supplement

    The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.

Study groups in NCT05301985
Study groupRoleWhat they receive
Fasting groupNo interventionconventional preoperative fasting protocol The participants in the Fasting group stopped oral intake at 12:00 pm, the night before surgery. After surgery the participants fasted until the recovery of function of the bowel.
Carbohydrate groupExperimentalpreoperative nutrition The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.
Receives: Dietary Supplement: preoperative nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean change in NLR values between conventional preoperative fasting protocol and a preoperative carbohydrate loading

    White blood counts with automated differential counts were analysed from peripheral venous blood samples using fluorescence flow cytometry method. The NLR value was calculated by following equation: NLR = the absolute neutrophil count (range of normality 4,0-7,0x10ᶺ9/L) / the absolute lymphocyte count (range of normality 1-3,7x10ᶺ9/L).

    Measured: fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.

  2. The mean change in delta NLR value between conventional preoperative fasting protocol and a preoperative carbohydrate loading

    Delta NLR value was defined as dynamic change in NLR value from basal value to the highest measured post-surgery NLR value. Delta NLR was calculated using following equation: Delta NRL = the highest measured post-surgery NLR value - basal NLR value.

    Measured: fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.

Secondary outcomes (2)

  1. The mean change in incidence and severity of postoperative complications assessed using the Clavien-Dindo Classification of Surgical Complications between conventional preoperative fasting protocol and a preoperative carbohydrate loading

    Postoperative complications were graded as follow: Grade I considered any deviation from the normal course without the need for pharmacological treatment or surgical, endoscopic and radiologic interventions. Grade II required pharmacological treatment with drugs other than such allowed for Grade I complications. Grade I and Grade II were considered minor postoperative complications. Grade III required surgical, endoscopic or radiological intervention without or with general anesthesia. Grade IV considered life-threatening complication required intensive care unit management. Grade V included death of patient. Grade III, IV and V were considered major complications.

    Measured: the incidence and severity of postoperative complications were assessed up to 30 days post-surgery. After discharge, participants were called by phone once a week and finally on the 30th day post-surgery.

  2. The mean change in characteristics of postoperative complications between conventional preoperative fasting protocol and a preoperative carbohydrate loading

    Characteristics of postoperative complications included: overall number of complications per group, number of participants without complications per group, number of participants with complications per group, number of participants with 1 complication per group, number of participants with 2 complications per group, number of participants with >2 complications per group and readmission rate per group within 30 days post-surgery.

    Measured: the characteristics of postoperative complications and readmission rate were assessed up to 30 days post-surgery. After discharge, participants were called by phone once a week and finally on the 30th day post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start4 May 2020
  3. Primary completion20 Dec 2021
  4. Study completion20 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients with diagnosed colon cancer were hospitalized and prepared for elective, open colon surgery at the Department of Surgery. Before surgical procedure, the patients were undergoing to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05301985
Sponsor's protocol ID
NR03/22
Status last verified
Mar 2022
First submitted
20 Mar 2022
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Morrison CE, Ritchie-McLean S, Jha A, Mythen M. Two hours too long: time to review fasting guidelines for clear fluids. Br J Anaesth. 2020 Apr;124(4):363-366. doi: 10.1016/j.bja.2019.11.036. Epub 2020 Jan 17. No abstract available.

    PubMed 31959387

  • Vano YA, Oudard S, By MA, Tetu P, Thibault C, Aboudagga H, Scotte F, Elaidi R. Optimal cut-off for neutrophil-to-lymphocyte ratio: Fact or Fantasy? A prospective cohort study in metastatic cancer patients. PLoS One. 2018 Apr 6;13(4):e0195042. doi: 10.1371/journal.pone.0195042. eCollection 2018.

    PubMed 29624591

  • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.

    PubMed 21376230

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Sarin A, Chen LL, Wick EC. Enhanced recovery after surgery-Preoperative fasting and glucose loading-A review. J Surg Oncol. 2017 Oct;116(5):578-582. doi: 10.1002/jso.24810. Epub 2017 Aug 28.

    PubMed 28846137

  • Abola RE, Gan TJ. Preoperative Fasting Guidelines: Why Are We Not Following Them?: The Time to Act Is NOW. Anesth Analg. 2017 Apr;124(4):1041-1043. doi: 10.1213/ANE.0000000000001964. No abstract available.

    PubMed 28319543

  • Singh SM, Liverpool A, Romeiser JL, Miller JD, Thacker J, Gan TJ, Bennett-Guerrero E. A U.S. survey of pre-operative carbohydrate-containing beverage use in colorectal enhanced recovery after surgery (ERAS) programs. Perioper Med (Lond). 2021 May 28;10(1):19. doi: 10.1186/s13741-021-00187-3.

    PubMed 34044894

  • Ackerman RS, Tufts CW, DePinto DG, Chen J, Altshuler JR, Serdiuk A, Cohen JB, Patel SY. How Sweet Is This? A Review and Evaluation of Preoperative Carbohydrate Loading in the Enhanced Recovery After Surgery Model. Nutr Clin Pract. 2020 Apr;35(2):246-253. doi: 10.1002/ncp.10427. Epub 2019 Oct 21.

    PubMed 31637778

  • Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

    PubMed 12765673

  • Patel SY, Trona N, Alford B, Laborde JM, Kim Y, Li R, Manley BJ, Gilbert SM, Sexton WJ, Spiess PE, Poch MA. Preoperative immunonutrition and carbohydrate loading associated with improved bowel function after radical cystectomy. Nutr Clin Pract. 2022 Feb;37(1):176-182. doi: 10.1002/ncp.10661. Epub 2021 Apr 26.

    PubMed 33900647

  • Cheng PL, Loh EW, Chen JT, Tam KW. Effects of preoperative oral carbohydrate on postoperative discomfort in patients undergoing elective surgery: a meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2021 Jun;406(4):993-1005. doi: 10.1007/s00423-021-02110-2. Epub 2021 Feb 25.

    PubMed 33629128

  • Noba L, Wakefield A. Are carbohydrate drinks more effective than preoperative fasting: A systematic review of randomised controlled trials. J Clin Nurs. 2019 Sep;28(17-18):3096-3116. doi: 10.1111/jocn.14919. Epub 2019 Jun 10.

    PubMed 31112338

  • Liu X, Zhang P, Liu MX, Ma JL, Wei XC, Fan D. Preoperative carbohydrate loading and intraoperative goal-directed fluid therapy for elderly patients undergoing open gastrointestinal surgery: a prospective randomized controlled trial. BMC Anesthesiol. 2021 May 21;21(1):157. doi: 10.1186/s12871-021-01377-8.

    PubMed 34020596

  • Chen X, Li K, Yang K, Hu J, Yang J, Feng J, Hu Y, Zhang X. Effects of preoperative oral single-dose and double-dose carbohydrates on insulin resistance in patients undergoing gastrectomy:a prospective randomized controlled trial. Clin Nutr. 2021 Apr;40(4):1596-1603. doi: 10.1016/j.clnu.2021.03.002. Epub 2021 Mar 7.

    PubMed 33752148

Questions about this trial

What is this clinical trial studying?

A study testing preoperative nutrition in people with Neutrophil and Lymphocyte, run by Nermina Rizvanović at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean change in NLR values between conventional preoperative fasting protocol and a preoperative carbohydrate loading (time frame: fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05301985, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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