NCT02062788

Evaluation of Preoperative Oral Rehydration Solution in Colectomy

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Insulin Resistance
• Postoperative Complication

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-02-14
• Last updated: 2017-04-27

Locations

1 site across 1 country: South Korea