Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Status Terminated

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02062788
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Terminated
Phase	Phase 3
Start date	February 2014
Completion date	January 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.