Preoperative Oral Carbohydrate and Postoperative Recovery in Diabetic Patients

Gastrointestinal Surgery Clinical Trial

Official title:

Impact of Preoperative Oral Carbohydrate on Recovery in Diabetic Patients After Gastrointestinal Surgery: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204344
• Other study ID #: 2017[1362]
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 7, 2018

Study information

• Verified date: September 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Surgery

Intervention

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.

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dong-Xin Wang

Country where clinical trial is conducted

China, 

References & Publications (20)

Alfonsi P, Slim K, Chauvin M, Mariani P, Faucheron JL, Fletcher D; Working Group of Société française d'anesthésie et réanimation (SFAR); Société française de chirurgie digestive (SFCD). French guidelines for enhanced recovery after elective colorectal surgery. J Visc Surg. 2014 Feb;151(1):65-79. doi: 10.1016/j.jviscsurg.2013.10.006. Epub 2013 Dec 27. — View Citation

An GQ, Zhao XL, Gao YC, Wang GY, Yu YM. [Effects of preoperative carbohydrate loading on the changes in serum tumor necrosis factor receptors 1 and 2 and insulin resistance in patients of colon carcinoma]. Zhonghua Yi Xue Za Zhi. 2008 Jul 29;88(29):2041-4. Chinese. — View Citation

Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7. — View Citation

Faria MS, de Aguilar-Nascimento JE, Pimenta OS, Alvarenga LC Jr, Dock-Nascimento DB, Slhessarenko N. Preoperative fasting of 2 hours minimizes insulin resistance and organic response to trauma after video-cholecystectomy: a randomized, controlled, clinical trial. World J Surg. 2009 Jun;33(6):1158-64. doi: 10.1007/s00268-009-0010-x. — View Citation

Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebø LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30. Review. — View Citation

Gustafsson UO, Nygren J, Thorell A, Soop M, Hellström PM, Ljungqvist O, Hagström-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7. — View Citation

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. — View Citation

Helminen H, Viitanen H, Sajanti J. Effect of preoperative intravenous carbohydrate loading on preoperative discomfort in elective surgery patients. Eur J Anaesthesiol. 2009 Feb;26(2):123-7. doi: 10.1097/EJA.0b013e328319be16. — View Citation

Horowitz M, O'Donovan D, Jones KL, Feinle C, Rayner CK, Samsom M. Gastric emptying in diabetes: clinical significance and treatment. Diabet Med. 2002 Mar;19(3):177-94. Review. — View Citation

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. — View Citation

Makuuchi R, Sugisawa N, Kaji S, Hikage M, Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol. 2017 Jan;43(1):210-217. doi: 10.1016/j.ejso.2016.07.140. Epub 2016 Aug 10. — View Citation

Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. — View Citation

Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damião A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66. — View Citation

Sada F, Krasniqi A, Hamza A, Gecaj-Gashi A, Bicaj B, Kavaja F. A randomized trial of preoperative oral carbohydrates in abdominal surgery. BMC Anesthesiol. 2014 Oct 17;14:93. doi: 10.1186/1471-2253-14-93. eCollection 2014. — View Citation

Singh BN, Dahiya D, Bagaria D, Saini V, Kaman L, Kaje V, Vagadiya A, Sarin S, Edwards R, Attri V, Jain K. Effects of preoperative carbohydrates drinks on immediate postoperative outcome after day care laparoscopic cholecystectomy. Surg Endosc. 2015 Nov;29(11):3267-72. doi: 10.1007/s00464-015-4071-7. Epub 2015 Jan 22. — View Citation

Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;(8):CD009161. doi: 10.1002/14651858.CD009161.pub2. Review. — View Citation

Viganò J, Cereda E, Caccialanza R, Carini R, Cameletti B, Spampinato M, Dionigi P. Effects of preoperative oral carbohydrate supplementation on postoperative metabolic stress response of patients undergoing elective abdominal surgery. World J Surg. 2012 Aug;36(8):1738-43. doi: 10.1007/s00268-012-1590-4. — View Citation

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. — View Citation

Zelic M, Štimac D, Mendrila D, Tokmadžic VS, Fišic E, Uravic M, Šustic A. Preoperative oral feeding reduces stress response after laparoscopic cholecystectomy. Hepatogastroenterology. 2013 Oct;60(127):1602-6. — View Citation

Zelic M, Stimac D, Mendrila D, Tokmadžic VS, Fišic E, Uravic M, Sustic A. Influence of preoperative oral feeding on stress response after resection for colon cancer. Hepatogastroenterology. 2012 Jul-Aug;59(117):1385-9. doi: 10.5754/hge10556. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Blood glucose variation	Difference between the highest and the lowest blood glucose levels.	From 22:00 on the day before surgery until 24 hours after surgery.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	All cause 30-day mortality	All cause 30-day mortality	At 30 days after surgery