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Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Primary Purpose

Insulin Resistance, Postoperative Complication

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oral rehydration solution
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Early Recovery After Surgery, Oral rehydration solution, Insulin resistance, Postoperative complication

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ORS group

Non-ORS group

Arm Description

Oral rehydration solution (ORS) treated group

Oral rehydration solution (ORS) untreated group

Outcomes

Primary Outcome Measures

Changes in HOMA-IR levels
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

Changes in Insulin levels
Changes in glucose level
Changes in cortisol level
Assessment of patient pain via Visual Analogue Scale
Reduction of postoperative complications
Changes in triglyceride level

Full Information

First Posted
January 20, 2014
Last Updated
April 25, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02062788
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
patient enrollment was failed.
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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. The change in HOMA-IR with shorter preoperative Nothing by mouth (NPO) period in ERAS patients HOMA-IR Index equation (evaluation of Insulin resistance) = Insulin (μU/ml) X blood glucose (mg/dl) / 405 HOMA-IR was statistically proven to have been lowered in patients who received ORS 2hr prior to surgery. 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 Additional benefits of shorter preoperative fasting Relieve of stress of fasting Help stabilize post-op triglyceride, cortisol, and glucose levels Reduce infectious complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Postoperative Complication
Keywords
Early Recovery After Surgery, Oral rehydration solution, Insulin resistance, Postoperative complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORS group
Arm Type
Experimental
Arm Description
Oral rehydration solution (ORS) treated group
Arm Title
Non-ORS group
Arm Type
No Intervention
Arm Description
Oral rehydration solution (ORS) untreated group
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral rehydration solution
Other Intervention Name(s)
NoNPO (Daesang)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in HOMA-IR levels
Description
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
Time Frame
6hr, 24hr, 48hr
Secondary Outcome Measure Information:
Title
Changes in Insulin levels
Time Frame
0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
Title
Changes in glucose level
Time Frame
0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
Title
Changes in cortisol level
Time Frame
0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr
Title
Assessment of patient pain via Visual Analogue Scale
Time Frame
Participants will be evaluated daily till discharge, an expected average of 6 days
Title
Reduction of postoperative complications
Time Frame
Participants will be evaluated daily till discharge, an expected average of 6 days
Title
Changes in triglyceride level
Time Frame
0hr (induction of general anesthesia), 24hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Bum Kang, Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
SeongNam
State/Province
GyeongGi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Evaluation of Preoperative Oral Rehydration Solution in Colectomy

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