Preoperative Oral Carbohydrate Load Versus Placebo in Major Elective Abdominal Surgery (PROCY): A Randomized, Placebo-controlled, Multicenter, Phase III Trial

Ann Surg. 2018 Apr;267(4):623-630. doi: 10.1097/SLA.0000000000002325.

Abstract

Objective: To explore whether preoperative oral carbohydrate (CHO) loading could achieve a reduction in the occurrence of postoperative infections.

Background: Hyperglycemia may increase the risk of infection. Preoperative CHO loading can achieve postoperative glycemic control.

Methods: This was a randomized, controlled, multicenter, open-label trial. Nondiabetic adult patients who were candidates for elective major abdominal operation were randomized (1:1) to a CHO (preoperative oral intake of 800 mL of water containing 100 g of CHO) or placebo group (intake of 800 mL of water). The blood glucose level was measured every 4 hours for 4 days. Insulin was administered when the blood glucose level was >180 mg/dL. The primary endpoint was the occurrence of postoperative infection. The secondary endpoint was the number of patients needing insulin.

Results: From January 2011 through December 2015, 880 patients were randomly allocated to the CHO (n = 438) or placebo (n = 442) group. From each group, 331 patients were available for the analysis. Postoperative infection occurred in 16.3% (54/331) of CHO group patients and 16.0% (53/331) of placebo group patients (relative risk 1.019, 95% confidence interval 0.720-1.442, P = 1.00). Insulin was needed in 8 (2.4%) CHO group patients and 53 (16.0%) placebo group patients (relative risk 0.15, 95% confidence interval 0.07-0.31, P < 0.001).

Conclusions: Oral preoperative CHO load is effective for avoiding a blood glucose level >180 mg/dL, but without affecting the risk of postoperative infectious complication.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdomen / surgery*
  • Administration, Oral
  • Aged
  • Blood Glucose / metabolism
  • Diet, Carbohydrate Loading*
  • Elective Surgical Procedures / adverse effects*
  • Female
  • Humans
  • Hyperglycemia / drug therapy
  • Hypoglycemic Agents / therapeutic use
  • Infection Control*
  • Insulin / therapeutic use
  • Male
  • Middle Aged
  • Postoperative Complications / blood
  • Postoperative Complications / prevention & control*
  • Preoperative Care / methods*
  • Prospective Studies
  • Risk Factors

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin