CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Oral carbohydrate (Outfast) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03204344
NCT03204344N/ACompleted

Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial

Dong-Xin Wang·interventional·Posted Jul 2, 2017·Updated Sep 9, 2021

In Brief

A clinical study evaluating Oral carbohydrate (Outfast) and Routine fasting for Gastrointestinal Surgery. Completed, enrolled 65 participants across 1 site.

Detailed Summary

For non-diabetic patients undergoing gastrointestinal surgery, preoperative oral carbohydrate improves postoperative recovery. The purpose of this pilot study is to investigate the impact of preoperative oral carbohydrate (outfast®) on the recovery in diabetic patients after gastrointestinal surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartAug 1, 2017
Primary CompletionMay 7, 2018
Study CompletionJun 7, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9 years ago

Interventions

Oral carbohydrate (Outfast)dietary

For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated by an endocrinologist according to patients' daily glucose controlling plan. For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated is the same way as described above.

Routine fastingother

For all patients, routine fasting (water drinking allowed) begin from 22:00 on the day before surgery until entering the operating room on the day of surgery. For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added in the 5% glucose (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, and magnesium sulfate) are added when considered necessary.