Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

NCT03204344 | Completed DMC

• 1 other identifier: 2017[1362]
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Surgery

Keywords

Gastrointestinal surgery; Preoperative oral carbohydrate; Diabetic patients; Postoperative recovery

Outcome Measures

Primary Outcomes (1)

• Recovery of gastrointestinal function

  Time to first flatus and defecation after surgery.

  From end of surgery until the time of first flatus and defecation, assessed up to 7 days after surgery.

Secondary Outcomes (7)

• Subjective feelings

  Before anesthesia induction and at 4-6 hours after surgery.

• Blood glucose variation

  From 22:00 on the day before surgery until 24 hours after surgery.

• Insulin resistance (in part of patients)

  Assessed at 24 hours after surgery.

• Length of stay in hospital after surgery.

  From end of surgery until hospital discharge, up to 30 days after surgery.

• Incidence of postoperative complications

  From end of surgery until 30 days after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

SHAM COMPARATOR

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

Interventions

Oral carbohydrate (Outfast) DIETARY_SUPPLEMENT

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.

Intervention group

Routine fasting OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refuse to participate in the study;
• Diagnosed with diaphragmatic hernia, gastric esophageal reflux disease or pregnancy;
• Previous history of total or partial gastrectomy;
• 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;
• Preoperative pyloric and/or intestinal obstruction;
• Combined surgery on other intra-abdominal organs or other parts of the body.

Sponsors & Collaborators

• Dong-Xin Wang: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (20)

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MeSH Terms

Interventions

Carbohydrates

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor who perform postoperative follow-up is masked to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Model Details: This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: May 7, 2018
• Study Completion: June 7, 2018
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

CN (1)