Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications
NCT ID: NCT05301985
Last Updated: 2022-03-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-04
Study Completion Date
2022-01-20
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Neutrophil
Lymphocyte
Postoperative Complications
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Caregivers
Investigators
Outcome Assessors
The surgeons, anesthetists, and outcome assessors were masking to the treatment allocation.
A nurse from the Department of Surgery performed the allocation into groups. The night before the operation, the nurse managed the patients according to the assigned intervention, but was not included in the study protocol. The next morning, the surgeon and anesthetist performed open elective colon surgery under general anesthesia, but without knowledge of the type of intervention.
Independent outcomes assessors evaluated patients up to 30 days post-surgery and were also masked, without knowledge of the type intervention.
A nurse from the Department of Surgery performed the allocation into groups. The night before the operation, the nurse managed the patients according to the assigned intervention, but was not included in the study protocol. The next morning, the surgeon and anesthetist performed open elective colon surgery under general anesthesia, but without knowledge of the type of intervention.
Independent outcomes assessors evaluated patients up to 30 days post-surgery and were also masked, without knowledge of the type intervention.
Study Groups
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Fasting group
conventional 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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Carbohydrate group
preoperative 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.
Group Type
EXPERIMENTAL
preoperative nutrition
Intervention Type
DIETARY_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.
Interventions
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preoperative 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.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* 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
* aged between 18 years and 70 years
* participants with ASA physical status class I-III
Exclusion Criteria
* 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
* 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.
* 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
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Nermina Rizvanović
OTHER
Sponsor Role
lead
Responsible Party
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Nermina Rizvanović
PhD Anesthesiology and Intensive Care Specialist
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Nermina Rizvanović, PhD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital Zenica, Crkvice 67, 72 000 Zenica, Bosnia and Herzegovina
Locations
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Cantonal Hospital Zenica
Zenica, , Bosnia and Herzegovina
Site Status
Countries
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Bosnia and Herzegovina
References
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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.
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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.
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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.
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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.
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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.
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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.
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Mik M, Dziki L, Berut M, Trzcinski R, Dziki A. Neutrophil to Lymphocyte Ratio and C-Reactive Protein as Two Predictive Tools of Anastomotic Leak in Colorectal Cancer Open Surgery. Dig Surg. 2018;35(1):77-84. doi: 10.1159/000456081. Epub 2017 Jan 28.
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Paliogiannis P, Deidda S, Maslyankov S, Paycheva T, Farag A, Mashhour A, Misiakos E, Papakonstantinou D, Mik M, Losinska J, Scognamillo F, Sanna F, Feo CF, Cherchi G, Xidas A, Zinellu A, Restivo A, Zorcolo L. Blood cell count indexes as predictors of anastomotic leakage in elective colorectal surgery: a multicenter study on 1432 patients. World J Surg Oncol. 2020 May 6;18(1):89. doi: 10.1186/s12957-020-01856-1.
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Zhang YY, Li WQ, Li ZF, Guo XH, Zhou SK, Lin A, Yan WH. Higher Levels of Pre-operative Peripheral Lymphocyte Count Is a Favorable Prognostic Factor for Patients With Stage I and II Rectal Cancer. Front Oncol. 2019 Sep 24;9:960. doi: 10.3389/fonc.2019.00960. eCollection 2019.
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Jakubowska K, Koda M, Kisielewski W, Kanczuga-Koda L, Grudzinska M, Famulski W. Pre- and postoperative neutrophil and lymphocyte count and neutrophil-to-lymphocyte ratio in patients with colorectal cancer. Mol Clin Oncol. 2020 Nov;13(5):56. doi: 10.3892/mco.2020.2126. Epub 2020 Aug 25.
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Xia LJ, Li W, Zhai JC, Yan CW, Chen JB, Yang H. Significance of neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, lymphocyte-to-monocyte ratio and prognostic nutritional index for predicting clinical outcomes in T1-2 rectal cancer. BMC Cancer. 2020 Mar 12;20(1):208. doi: 10.1186/s12885-020-6698-6.
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Lobo DN, Gianotti L, Adiamah A, Barazzoni R, Deutz NEP, Dhatariya K, Greenhaff PL, Hiesmayr M, Hjort Jakobsen D, Klek S, Krznaric Z, Ljungqvist O, McMillan DC, Rollins KE, Panisic Sekeljic M, Skipworth RJE, Stanga Z, Stockley A, Stockley R, Weimann A. Perioperative nutrition: Recommendations from the ESPEN expert group. Clin Nutr. 2020 Nov;39(11):3211-3227. doi: 10.1016/j.clnu.2020.03.038. Epub 2020 Apr 18.
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BACKGROUND
Other Identifiers
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NR03/22
Identifier Type: -
Identifier Source: org_study_id
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