Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail

Medical University of Gdansk1 site in 1 country400 target enrollmentJuly 20, 2020

ConditionsObesity, Morbid

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Obesity, Morbid
Sponsor: Medical University of Gdansk
Enrollment: 400
Locations: 1
Primary Endpoint: QoR40 score
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

Registry

clinicaltrials.gov

Start Date

July 20, 2020

End Date

October 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Medical University of Gdansk

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Obtaining written and informed patient consent.
•No medical contraindications to perform a bariatric operation
•No contraindications for the use of a rich carbohydrate drink

Exclusion Criteria

•No consent to participate in the study
•Age under 18 years
•The intolerance of the carbohydrate drink used in the test
•The contraindications to perform bioimpedance measurements of body composition

Outcomes

Primary Outcomes

QoR40 score

Time Frame: 1st postoperatie day

Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)

Secondary Outcomes

Length of hospital stay(From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days)
HOMA-IR(first assay one month before the operation, the second assay on the first postoperative day)
Body composition(first assay one month before the operation, the second assay on the first postoperative day)