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Trial record 4 of 4 for:    21668975 [PUBMED-IDS]

Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03204344
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Surgery Dietary Supplement: Oral carbohydrate (Outfast) Other: Routine fasting Not Applicable

Detailed Description:
Studies show that avoiding long-time fasting by oral carbohydrates 2 hours before surgery attenuates discomfort and anxiety; it also reduces stress, insulin resistance and catabolism in patients undergoing gastrointestinal surgery, resulting in earlier recovery of gastrointestinal function and short length of hospital stay after surgery. However, for diabetic patients scheduled to undergo gastrointestinal surgery, the risks and benefits of preopertive oral carbohydrate remain unclear. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor who perform postoperative follow-up is masked to group assignment.
Primary Purpose: Prevention
Official Title: Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Intervention group

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.

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.

Dietary Supplement: Oral carbohydrate (Outfast)

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.


Sham Comparator: Control group

For all patients, routine fasting (drinking water allowed) begins from 22:00 on the day before surgery, water fasting begins from 6:00 on the day of surgery.

For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided from 6:00. 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 (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, magnesium sulfate) are added when becessary.

Other: Routine fasting

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.





Primary Outcome Measures :
  1. Recovery of gastrointestinal function [ Time Frame: From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery. ]
    Time to first flatus and defecation after surgery.


Secondary Outcome Measures :
  1. Subjective feelings [ Time Frame: Before anesthesia induction and at 4-6 hours after surgery. ]
    Four subjective feelings, including the degree of being thirsty, hungry, tired and anxious, are assessed with Numeric Rating Scale (NRS, an 11-point scale where 0 = no feeling at all and 10 = the worst feeling).

  2. Blood glucose variation [ Time Frame: From 22:00 on the day before surgery until 24 hours after surgery. ]
    Difference between the highest and the lowest blood glucose levels.

  3. Insulin resistance [ Time Frame: Assessed at 24 hours after surgery. ]
    Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation.

  4. Length of stay in hospital after surgery. [ Time Frame: From end of surgery until hospital discharge, up to 30 days after surgery. ]
    Length of stay in hospital after surgery.

  5. Incidence of postoperative complications [ Time Frame: From end of surgery until 30 days after surgery ]
    Postoperative complications are defined as newly occurred medical conditions that have harmful effects on patients' recovery and require therapeutic intervention.

  6. Time to first walking in the ground and distance of walking after surgery. [ Time Frame: During the first 5 days after surgery ]
    Time to first walking in the ground and distance of walking after surgery.

  7. All cause 30-day mortality [ Time Frame: At 30 days after surgery ]
    All cause 30-day mortality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 18 years and beyond;
  2. Diagnosed with type 2 diabetes before surgery;
  3. Scheduled to undergo elective gastrointestinal surgery with anticipated duration of 2 hours or more;
  4. Provide signed writen informed consents.

Exclusion Criteria:

  1. Refuse to participate in the study;
  2. Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
  3. Previous history of total or partial gastrectomy;
  4. Preoperative New York Heart Assocition (NYHA) class IV, renal failure (requirement of renal replacement therapy), severe hepatic disease (Child-Pugh class C), or American Society of Anesthesiologists (ASA) class IV or higher;
  5. Preoperative pyloric and/or intestinal obstruction;
  6. Combined surgery on other intra-abdominal organs or other parts of the body.

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): NCT03204344


Contacts
Contact: Dong-Xin Wang, MD, PhD 8610 83572784 wangdongxin@hotmail.com
Contact: Xue Li, MD 8610 83572460 3999165@163.com

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    8610 83572784    wangdongxin@hotmail.com   
Contact: Xue Li, MD    8610 83572460    3999165@163.com   
Principal Investigator: Xue Li, MD         
Sponsors and Collaborators
Dong-Xin Wang
Investigators
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital

Publications:

Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03204344     History of Changes
Other Study ID Numbers: 2017[1362]
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be available by contacting Dr. Xue Li (lixuepku@hotmail.com) after the trial is completed.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Gastrointestinal surgery
Preoperative oral carbohydrate
Diabetic patients
Postoperative recovery

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Magnesium Sulfate
Hypoglycemic Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents