Preoperative Oral Carbohydrate Loading in Gynecologic Surgery

Postoperative Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955419
• Other study ID #: KBSMC 2019-04-015-001
• Status: Completed
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Recovery

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eunah Cho, MD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to readiness to discharge (TRD)	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.	2 days after surgery