Evaluation of Preoperative Oral Rehydration Solution in Colectomy

NCT ID: NCT02062788

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-01-31

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

Conditions

Insulin Resistance; Postoperative Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ORS group

Oral rehydration solution (ORS) treated group

Group Type: EXPERIMENTAL

Oral rehydration solution

Intervention Type: DIETARY_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

Non-ORS group

Oral rehydration solution (ORS) untreated group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NoNPO (Daesang)

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung-Bum Kang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Bum Kang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-1310/224-007

Identifier Type: OTHER

Identifier Source: secondary_id

ORS-colectomy

Identifier Type: -

Identifier Source: org_study_id