Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Phase 3

Terminated

• Conditions: Insulin Resistance; Postoperative Complication
• Interventions: Dietary Supplement: Oral rehydration solution

• Registration Number: NCT02062788
• Lead Sponsor: Seoul National University Hospital

Brief 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

Study Timeline

• Study First Submitted: 2014-01-20
• Study Start: 2014-02
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORS group	Oral rehydration solution	Oral rehydration solution (ORS) treated group

Primary Outcome Measures

Name	Time	Method
Changes in HOMA-IR levels	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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 SeongNam, GyeongGi, Korea, Republic of