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Insulin ResistancePhase 3NCT02062788

Evaluation of Preoperative Oral Rehydration Solution in Colectomy

A Phase 3 study testing Oral rehydration solution in people with Insulin Resistance and Postoperative Complication, run by Seoul National University Hospital at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Oral rehydration solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
Feb 2014to Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

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

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.

Read the 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
  3. HOMA-IR Index equation (evaluation of Insulin resistance) = Insulin (μU/ml) X blood glucose (mg/dl) / 405
  4. HOMA-IR was statistically proven to have been lowered in patients who received ORS 2hr prior to surgery.
  5. 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
  1. Additional benefits of shorter preoperative fasting
  2. Relieve of stress of fasting
  3. Help stabilize post-op triglyceride, cortisol, and glucose levels
  4. Reduce infectious complications
Being tested
Oral rehydration solution
Keywords
Early Recovery After Surgery, Oral rehydration solution, Insulin resistance, Postoperative complication
Medical subject headings
Insulin Resistance, Postoperative Complications, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral rehydration solutionDietary supplement

    Also called NoNPO (Daesang)

    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

Study groups in NCT02062788
Study groupRoleWhat they receive
ORS groupExperimentalOral rehydration solution (ORS) treated group
Receives: Dietary Supplement: Oral rehydration solution
Non-ORS groupNo interventionOral rehydration solution (ORS) untreated group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6hr, 24hr, 48hr

Secondary outcomes (6)

  1. Changes in Insulin levels

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

  2. Changes in glucose level

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

  3. Changes in cortisol level

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

  4. Assessment of patient pain via Visual Analogue Scale

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

  5. Reduction of postoperative complications

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

  6. Changes in triglyceride level

    Measured: 0hr (induction of general anesthesia), 24hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Why it stopped: patient enrollment was failed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02062788
Sponsor's protocol ID
ORS-colectomy
Other IDs
B-1310/224-007
Status last verified
Apr 2017
First submitted
20 Jan 2014
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral rehydration solution in people with Insulin Resistance and Postoperative Complication, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: patient enrollment was failed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HOMA-IR levels (time frame: 6hr, 24hr, 48hr). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02062788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.

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