Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Overview

Elective colectomy procedures typically require bowel preparation starting 2 days prior to the surgery. Osmotic laxatives such as Colyte® are administered 2 days prior, and Nothing by mouth (NPO) is required 1 day prior to ensure no fecal residue is left in the bowel. Though it may ensure a cleaner and safer surgery, this longer period of starvation increases insulin resistance and may increase post-op complications. However, there is evidence that administration of oral rehydration solution(ORS) prior to surgery reduces insulin resistance. Our purpose is to evaluate the difference of insulin resistance in those who received ORS 1 day prior to surgery and those who did not.

Full Title of Study: “Preoperative Oral Carbohydrate-rich Solution in Colorectal Cancer Patients: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Detailed Description

1. Enhanced Recovery After Surgery (ERAS) Enhanced Recovery After Surgery(ERAS) was introduced in the early 2000s by Kehlet et.al., and was applied primarily to patients receiving colectomy. As the knowledge and understanding of this concept continues to grow, we are now able to change the way we treat pre- and post- operative patients. In Europe, it has been proven that applying this concept to patients resulted in decreased length of post-operative hospital stay, post-op complications and overall hospital costs. 2. The change in HOMA-IR with shorter preoperative Nothing by mouth (NPO) period in ERAS patients 1. HOMA-IR Index equation (evaluation of Insulin resistance) = Insulin (μU/ml) X blood glucose (mg/dl) / 405 2. HOMA-IR was statistically proven to have been lowered in patients who received ORS 2hr prior to surgery. 3. Reference – Increased insulin resistance induces hyperglycemia – Toxicity of post-op hyperglycemia and their relation to post-op complications – Insulin resistance increases in procedures such as herniorrhaphy or laparoscopic cholecystectomy. Administration of preoperative carbohydrates decrease post-op nausea and vomiting – Conventional pre-op 8hr fasting increases insulin resistance and influences increased glucose levels 3. Additional benefits of shorter preoperative fasting 1. Relieve of stress of fasting 2. Help stabilize post-op triglyceride, cortisol, and glucose levels 3. Reduce infectious complications

Interventions

  • Dietary Supplement: Oral rehydration solution
    • Preoperative day #1: able to drink Oral rehydration solution (ORS) freely On day of Surgery: Allowed administration until 2hrs prior to surgery. 8AM patients(the first patients to undergo surgery of the day) are recommended to administer ORS at 5:30AM

Arms, Groups and Cohorts

  • Experimental: ORS group
    • Oral rehydration solution (ORS) treated group
  • No Intervention: Non-ORS group
    • Oral rehydration solution (ORS) untreated group

Clinical Trial Outcome Measures

Primary Measures

  • Changes in HOMA-IR levels
    • Time Frame: 6hr, 24hr, 48hr
    • HOMA-IR = Insulin (μU/ml) X blood glucose (mg/dl) / 405 insulin and glucose levels are obtained 6hrs, 24hrs, 48hrs post-op Derive the value using the obtained sample variables into the HOMA-IR equation and comparison using statistical analytic methods

Secondary Measures

  • Changes in Insulin levels
    • Time Frame: 0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
  • Changes in glucose level
    • Time Frame: 0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
  • Changes in cortisol level
    • Time Frame: 0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
  • Assessment of patient pain via Visual Analogue Scale
    • Time Frame: Participants will be evaluated daily till discharge, an expected average of 6 days
  • Reduction of postoperative complications
    • Time Frame: Participants will be evaluated daily till discharge, an expected average of 6 days
  • Changes in triglyceride level
    • Time Frame: 0hr (induction of general anesthesia), 24hr

Participating in This Clinical Trial

Inclusion Criteria

  • ASA grade I~II (DM, CVA, COPD, ESRD, MI, TIA etc. excluded) – Age: adults age 19~75 – Patients undergoing elective colon cancer surgery – Able to take the ORS per orally. Able to swallow without trouble of aspiration tendencies – BMI of less than 27.5 – Child-Turcotte-Pugh Classification score of less than 6 Exclusion Criteria:

  • emergency cases such as obstruction or perforation – food allergy – abdominal distension at present – prior gastric surgery

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Collaborator
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sung-Bum Kang, Associate Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Sung-Bum Kang, Ph.D., Principal Investigator, Seoul National University Bundang Hospital

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