NCT02062788

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

January 20, 2014

Last Update Submit

April 25, 2017

Conditions

Insulin ResistancePostoperative Complication

Keywords

Early Recovery After SurgeryOral rehydration solutionInsulin resistancePostoperative complication

Outcome Measures

Primary Outcomes (1)

  • 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

    6hr, 24hr, 48hr

Secondary Outcomes (6)

  • Changes in Insulin levels

    0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr

  • Changes in glucose level

    0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr

  • Changes in cortisol level

    0hr (induction of general anaesthesia), postop 6hr, 24hr, 48hr

  • Assessment of patient pain via Visual Analogue Scale

    Participants will be evaluated daily till discharge, an expected average of 6 days

  • Reduction of postoperative complications

    Participants will be evaluated daily till discharge, an expected average of 6 days

  • +1 more secondary outcomes

Study Arms (2)

ORS group

EXPERIMENTAL

Oral rehydration solution (ORS) treated group

Dietary Supplement: Oral rehydration solution

Non-ORS group

NO INTERVENTION

Oral rehydration solution (ORS) untreated group

Interventions

Oral rehydration solutionDIETARY_SUPPLEMENT

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

Also known as: NoNPO (Daesang)
ORS group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Insulin ResistancePostoperative ComplicationsOsteoarthritis

Interventions

World Health Organization oral rehydration solution

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sung-Bum Kang, Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 20, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

KR(1)