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Completed

NCT Number: NCT03955419

Preoperative Oral Carbohydrate Loading in Gynecologic Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

NO-NPO (Daesang WelLife Co., Ltd., Korea)

Dietary Supplement

800 mL of carbohydrate beverage consists of 12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg.

Primary outcomes

  1. Quality of recovery (QoR)-15 score

    Time frame: 2 days after surgery

    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.

Secondary outcomes

  1. time to readiness to discharge (TRD)

    Time frame: 2 days after surgery

    This measures the time when the patients are ready to discharge from the hospital after surgery. It assesses five criteria: (1) tolerance of oral intake, (2) recovery of lower gastrointestinal function, (3) adequate pain control with oral analgesia, (4) ability to mobilize and perform self-care, and (5) clinical examination and laboratory tests. TRD is defined by the time from the operation end time to the time when time to readiness to discharge criteria is fulfilled.

Sponsors and collaborators

Lead sponsor

Eunah Cho, MD

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2019
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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