Effect of Preoperative Oral Carbohydrates on Quality of Recovery

NCT02555020 | Completed Phase 3 DMC

• 1 other identifier: 3-2015-0158
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief Summary

Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.

Conditions

Evidence of Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery score using the QoR-40 Questionnaire

  We check the QoR-40 Questionnaire at discharge day

  We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days

Study Arms (3)

Allocated to MN NPO group,

EXPERIMENTAL

1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to MN group 4. Patients were NPO from mid night (MN) to Surgery

Dietary Supplement: Allocated to MN NPO group,

Allocated to Placebo group

PLACEBO COMPARATOR

1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to Placebo group 4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.

Dietary Supplement: Allocated to Placebo group

Allocated to Carbohydrated group

ACTIVE COMPARATOR

1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to Carbohydrated group 4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Dietary Supplement: Allocated to Carbohydrated group

Interventions

Allocated to Carbohydrated group DIETARY_SUPPLEMENT

Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Allocated to Carbohydrated group

Allocated to Placebo group DIETARY_SUPPLEMENT

Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.

Allocated to Placebo group

Allocated to MN NPO group, DIETARY_SUPPLEMENT

Patients received NPO from MN.

Allocated to MN NPO group,

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (I/II)
• Laparoscopic cholecystectomy.
• KAROFSKY PERFORMANCE SCALE \>70,
• No history of major operation

You may not qualify if:

• DM patients
• GE reflux Hx patients.
• No- compliance,
• Previous Abdominal Surgery History

Sponsors & Collaborators

• Yonsei University: lead

Related Publications (1)

• Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Cholecystectomy: A Randomized, Double Blind, Placebo-Controlled Trial. World J Surg. 2018 Oct;42(10):3150-3157. doi: 10.1007/s00268-018-4717-4.

  PMID: 29915988 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GangNam Severance Hospital

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 21, 2015
• Study Start: September 1, 2015
• Primary Completion: December 22, 2016
• Study Completion: December 23, 2016
• Last Updated: September 18, 2017

Record last verified: 2017-09