Preoperative Oral Carbohydrate Loading in Gynecologic Surgery
Randomized Controlled Trial Comparing Preoperative Oral Carbohydrate Loading With Standard Overnight Fasting in Gynecologic Surgery.
1 other identifier
interventional
88
1 country
1
Brief Summary
The advantage of carbohydrate loading in minimally invasive surgeries are not well established. We designed this study to evaluate whether preoperative oral carbohydrate improve postoperative recovery after laparoscopic gynecologic surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
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
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedMay 11, 2020
May 1, 2020
8 months
May 16, 2019
May 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of recovery (QoR)-15 score
This score measures the quality of recovery after surgery in 2 dimensions, which are the physical well-being (in 9 items) and mental well-being (6 items). Each item is rated from 0 (poor) to 10 (excellent). A sum of each score represents the QoR of the patients.
2 days after surgery
Secondary Outcomes (1)
time to readiness to discharge (TRD)
2 days after surgery
Study Arms (2)
Control group
NO INTERVENTIONParticipants in the control group will be fasted from midnight until surgery.
Study group
EXPERIMENTALParticipants will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg). They will drink this beverage freely, starting from the evening before surgery until 2 hours before surgery.
Interventions
800 mL of carbohydrate beverage consists of 12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg.
Eligibility Criteria
You may qualify if:
- age between 18 and 70 years American Society of Anesthesiologists physical status (ASAPS) classification I-II absence of pregnancy or lactation at the time of surgery.
You may not qualify if:
- suspicious delayed gastric emptying such as GERD or gastrointestinal surgery metabolic disorders such as diabetes known contraindications to NSAID or opioid physically disabled severe psychiatric or mental disorders alcoholism, drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eunah Cho, MDlead
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Related Publications (1)
Cho EA, Lee NH, Ahn JH, Choi WJ, Byun JH, Song T. Preoperative Oral Carbohydrate Loading in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 May;28(5):1086-1094.e1. doi: 10.1016/j.jmig.2020.12.002. Epub 2020 Dec 10.
PMID: 33310170DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eunah Cho, M.Dm.
Kangbuk Samsung Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 20, 2019
Study Start
July 25, 2019
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
May 11, 2020
Record last verified: 2020-05