NCT03955419

Preoperative Oral Carbohydrate Loading in Gynecologic Surgery

Randomized Controlled Trial Comparing Preoperative Oral Carbohydrate Loading With Standard Overnight Fasting in Gynecologic Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Eunah Cho, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be conducted in the female adult patient scheduled for laparoscopic gynecologic surgery for benign or premalignant condition. Patients with American Society of Anesthesiologist physical status classification I-II, not pregnant or on lactation will be included. Patients with underlying disease that will delay gastric emptying (GERD, history of gastrointestinal surgery, diabetes), or contraindicated to NSAID or opioid, psychiatric or mental disorders, alcoholism, or drug abuse will be excluded. Participants will be randomized into 2 group: the control group and the study group. Randomization will be conducted via random block with stratification generated by the http://www.randomization.com with 1:1 allocation. The sequence will be kept in opaque, sealed envelopes until the day before the study date. One investigator, not involved in the outcome assessment, opened the envelope on the day before the surgery, and allocated participants in each group. After having regular diet until the evening before surgery, participants allocate in the control group were kept fasted from midnight until surgery. Participants in the study group will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg). The participants in the study group will freely drink carbohydrate beverage starting from the evening before surgery up to 2 hours before surgery. The postoperative quality of recovery (QoR) score, time to readiness to discharge, patient satisfaction, postoperative nausea and vomiting, change in body weight, and insulin resistance will be assessed.

Conditions

• Postoperative Recovery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NO-NPO (Daesang WelLife Co., Ltd., Korea)	800 mL of carbohydrate beverage consists of 12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg.

Timeline

• Start date: 2019-07-25
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2019-05-20
• Last updated: 2020-05-11

Locations

1 site across 1 country: South Korea