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

NCT05301985 | Completed DMC

• 1 other identifier: NR03/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. Hypothesis was: preoperative carbohydrate loading reduces postoperative NLR value and reduces the incidence and severity of postoperative complications in colorectal surgery.

Conditions

Neutrophil; Lymphocyte; Postoperative Complications

Keywords

fasting; carbohydrate; colorectal carcinoma; nutritional status

Outcome Measures

Primary Outcomes (2)

• 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).

  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 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.

  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)

• 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

  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.

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

  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.

Study Arms (2)

Fasting group

NO INTERVENTION

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.

Carbohydrate group

EXPERIMENTAL

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.

Dietary Supplement: preoperative nutrition

Interventions

preoperative nutrition 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.

Carbohydrate group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nermina Rizvanović: lead

Study Sites (1)

Cantonal Hospital Zenica

Zenica, 72 000, Bosnia and Herzegovina

Location

Related Publications (27)

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MeSH Terms

Conditions

Postoperative Complications; Fasting; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Nermina Rizvanović, PhD

  Cantonal Hospital Zenica, Crkvice 67, 72 000 Zenica, Bosnia and Herzegovina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Anesthesiology and Intensive Care Specialist

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 31, 2022
• Study Start: May 4, 2020
• Primary Completion: December 20, 2021
• Study Completion: January 20, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

BO (1)