Clinical trial NCT02062788: Evaluation of Preoperative Oral Rehydration Solution in Colectomy
Official title: Preoperative Oral Carbohydrate-rich Solution in Colorectal Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Insulin Resistance
Postoperative Complication
Keywords: Early Recovery After Surgery
Oral rehydration solution
Insulin resistance
Postoperative complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2014-02-14
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in HOMA-IR levels
timeFrame: 6hr, 24hr, 48hr
Secondary outcomes:
measure: Changes in Insulin levels
timeFrame: 0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
measure: Changes in glucose level
timeFrame: 0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
measure: Changes in cortisol level
timeFrame: 0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
measure: Assessment of patient pain via Visual Analogue Scale
timeFrame: Participants will be evaluated daily till discharge, an expected average of 6 days
measure: Reduction of postoperative complications
timeFrame: Participants will be evaluated daily till discharge, an expected average of 6 days
measure: Changes in triglyceride level
timeFrame: 0hr (induction of general anesthesia), 24hr
Other outcomes:
Locations:
city: SeongNam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: GyeongGi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sung-Bum Kang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: