Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02062788
• Other study ID #: ORS-colectomy
• Secondary ID: B-1310/224-007
• Status: Terminated
• Phase: Phase 3
• First received: January 20, 2014
• Last updated: April 25, 2017
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Postoperative Complication
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	GyeongGi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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