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Preoperative Oral Carbohydrate Loading in Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT03955419
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Eunah Cho, MD, Kangbuk Samsung Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Recovery Dietary Supplement: NO-NPO (Daesang WelLife Co., Ltd., Korea) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial Comparing Preoperative Oral Carbohydrate Loading With Standard Overnight Fasting in Gynecologic Surgery.
Actual Study Start Date : July 25, 2019
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 30, 2020
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Participants in the control group will be fasted from midnight until surgery.
Experimental: Study group
Participants 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with indication for laparoscopic gynecologic surgery for benign or premalignant gynecologic conditions
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955419


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Sponsors and Collaborators
Eunah Cho, MD
Investigators
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Principal Investigator: Eunah Cho, M.Dm. Kangbuk Samsung Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eunah Cho, MD, Clinical Assistant Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT03955419    
Other Study ID Numbers: KBSMC 2019-04-015-001
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No