Preoperative Carbohydrate Loading in Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title:

Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486079
• Other study ID #: PreOpxBariatric
• Status: Recruiting
• Phase: Phase 4
• Start date: July 20, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: July 2020
• Source: Medical University of Gdansk
• Contact: Maciej Wilczynski
• Phone: 603383368
• Email: mwilczynski[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 31, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obtaining written and informed patient consent.

• No medical contraindications to perform a bariatric operation

• No contraindications for the use of a rich carbohydrate drink

Exclusion Criteria:

• No consent to participate in the study

• Age under 18 years

• The intolerance of the carbohydrate drink used in the test

• The contraindications to perform bioimpedance measurements of body composition

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Dietary Supplement:
• Nutricia PreOp
A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.

Locations

Country	Name	City	State
Poland	Department of General, Endocrine and Transplant Surgery Medical University of Gdansk	Gdansk	Pomerania

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21. Review. — View Citation

Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Baria — View Citation

Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9. — View Citation

Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR40 score	Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)	1st postoperatie day
Secondary	HOMA-IR	changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)	first assay one month before the operation, the second assay on the first postoperative day
Secondary	Body composition	changes in body composition will be assessed by electric bioimpedance method	first assay one month before the operation, the second assay on the first postoperative day
Secondary	Length of hospital stay	length of stay record in hours	From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days