PMID- 28582271
OWN - NLM
STAT- MEDLINE
DCOM- 20190401
LR  - 20190401
IS  - 1528-1140 (Electronic)
IS  - 0003-4932 (Linking)
VI  - 267
IP  - 4
DP  - 2018 Apr
TI  - Preoperative Oral Carbohydrate Load Versus Placebo in Major Elective Abdominal 
      Surgery (PROCY): A Randomized, Placebo-controlled, Multicenter, Phase III Trial.
PG  - 623-630
LID - 10.1097/SLA.0000000000002325 [doi]
AB  - 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.
FAU - Gianotti, Luca
AU  - Gianotti L
AD  - School of Medicine and Surgery, Milano-Bicocca University, San Gerardo Hospital, 
      Monza, Italy.
FAU - Biffi, Roberto
AU  - Biffi R
AD  - Department of Gastrointestinal Surgery, European Institute of Oncology, Milan, 
      Italy.
FAU - Sandini, Marta
AU  - Sandini M
AD  - School of Medicine and Surgery, Milano-Bicocca University, San Gerardo Hospital, 
      Monza, Italy.
FAU - Marrelli, Daniele
AU  - Marrelli D
AD  - Department of Medicine, Surgery and Neurosciences, Unit of Surgical Oncology, 
      University of Siena, Siena, Italy.
FAU - Vignali, Andrea
AU  - Vignali A
AD  - Department of Gastrointestinal Surgery, San Raffaele Scientific Institute, Vita e 
      Salute University, Milan, Italy.
FAU - Caccialanza, Riccardo
AU  - Caccialanza R
AD  - Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, 
      Italy.
FAU - Vigano, Jacopo
AU  - Vigano J
AD  - Department of Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
FAU - Sabbatini, Annarita
AU  - Sabbatini A
AD  - Department of Gastrointestinal Surgery, European Institute of Oncology, Milan, 
      Italy.
FAU - Di Mare, Giulio
AU  - Di Mare G
AD  - Department of Medicine, Surgery and Neurosciences, Unit of Surgical Oncology, 
      University of Siena, Siena, Italy.
FAU - Alessiani, Mario
AU  - Alessiani M
AD  - Department of Surgery, ASST Pavia and Department of Clinical and Surgical 
      Sciences, University of Pavia, Pavia, Italy.
FAU - Antomarchi, Francesco
AU  - Antomarchi F
AD  - Department of Urology, San Gerardo Hospital, Monza, Italy.
FAU - Valsecchi, Maria Grazia
AU  - Valsecchi MG
AD  - Centre of Biostatistics for Clinical Epidemiology, School of Medicine and 
      Surgery, Milano-Bicocca University, Monza, Italy.
FAU - Bernasconi, Davide P
AU  - Bernasconi DP
AD  - Centre of Biostatistics for Clinical Epidemiology, School of Medicine and 
      Surgery, Milano-Bicocca University, Monza, Italy.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ann Surg
JT  - Annals of surgery
JID - 0372354
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Abdomen/*surgery
MH  - Administration, Oral
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - *Diet, Carbohydrate Loading
MH  - Elective Surgical Procedures/*adverse effects
MH  - Female
MH  - Humans
MH  - Hyperglycemia/drug therapy
MH  - Hypoglycemic Agents/therapeutic use
MH  - *Infection Control
MH  - Insulin/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/blood/*prevention & control
MH  - Preoperative Care/*methods
MH  - Prospective Studies
MH  - Risk Factors
EDAT- 2017/06/06 06:00
MHDA- 2019/04/02 06:00
CRDT- 2017/06/06 06:00
PHST- 2017/06/06 06:00 [pubmed]
PHST- 2019/04/02 06:00 [medline]
PHST- 2017/06/06 06:00 [entrez]
AID - 10.1097/SLA.0000000000002325 [doi]
PST - ppublish
SO  - Ann Surg. 2018 Apr;267(4):623-630. doi: 10.1097/SLA.0000000000002325.