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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective feelings | 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). | Before anesthesia induction and at 4-6 hours after surgery. |
| Blood glucose variation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20101593 | Background | Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963. | |
| 15739210 | Background | Hausel J, Nygren J, Thorell A, Lagerkranser M, Ljungqvist O. Randomized clinical trial of the effects of oral preoperative carbohydrates on postoperative nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2005 Apr;92(4):415-21. doi: 10.1002/bjs.4901. |
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IPD will be available by contacting Dr. Xue Li (lixuepku@hotmail.com) after the trial is completed.
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| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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This is a outcomes assessor-blinded, randomized controlled trial with two parallel arms.
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Outcomes assessor who perform postoperative follow-up is masked to group assignment.
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| 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. |
|
Difference between the highest and the lowest blood glucose levels. |
| From 22:00 on the day before surgery until 24 hours after surgery. |
| Insulin resistance (in part of patients) | Insulin resistance is calculated with the Homeostatic model assessment-insulin resistance (HOMA-IR) equation. | Assessed at 24 hours after surgery. |
| Length of stay in hospital 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 | Postoperative complications are defined as newly occurred medical conditions that have harmful effects on patients' recovery and require therapeutic intervention. | From end of surgery until 30 days after surgery |
| Time to first walking in the ground and distance of walking after surgery. | Time to first walking in the ground and distance of walking after surgery. | During the first 5 days after surgery |
| All cause 30-day mortality | All cause 30-day mortality | At 30 days after surgery |
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| 24634929 | Background | Zelic M, Stimac D, Mendrila D, Tokmadzic VS, Fisic E, Uravic M, Sustic A. Preoperative oral feeding reduces stress response after laparoscopic cholecystectomy. Hepatogastroenterology. 2013 Oct;60(127):1602-6. |
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| 23406311 | Background | Lidder P, Thomas S, Fleming S, Hosie K, Shaw S, Lewis S. A randomized placebo controlled trial of preoperative carbohydrate drinks and early postoperative nutritional supplement drinks in colorectal surgery. Colorectal Dis. 2013 Jun;15(6):737-45. doi: 10.1111/codi.12130. |
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