Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Preoperative Oral Carbohydrate-rich Solution in Colorectal Cancer Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Insulin Resistance; Postoperative Complication
• Intervention / Treatment: Dietary supplement: Oral rehydration solution

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • GyeongGi
    • SeongNam, GyeongGi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ORS group; Oral rehydration solution (ORS) treated group	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; Other Names: NoNPO (Daesang)
No Intervention: Non-ORS group; Oral rehydration solution (ORS) untreated group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HOMA-IR levels	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	6hr, 24hr, 48hr

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Sung-Bum Kang, Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Insulin resistance; Postoperative complication; Oral rehydration solution; Early Recovery After Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Postoperative Complications
• Other Study ID Numbers: ORS-colectomy; B-1310/224-007 (Other Identifier: SNUBH IRB)