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Evaluation of Preoperative Oral Rehydration Solution in Colectomy

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02062788
Enrollment
10
Registered
2014-02-14
Start date
2014-02-28
Completion date
2016-01-31
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Postoperative Complication

Keywords

Early Recovery After Surgery, Oral rehydration solution, Insulin resistance, Postoperative complication

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

Interventions

DIETARY_SUPPLEMENTOral 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

Sponsors

Seoul National University Bundang Hospital
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in HOMA-IR levels6hr, 24hr, 48hrHOMA-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

MeasureTime frame
Changes in glucose level0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
Changes in cortisol level0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
Changes in Insulin levels0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
Reduction of postoperative complicationsParticipants will be evaluated daily till discharge, an expected average of 6 days
Changes in triglyceride level0hr (induction of general anesthesia), 24hr
Assessment of patient pain via Visual Analogue ScaleParticipants will be evaluated daily till discharge, an expected average of 6 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026