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Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy

Primary Purpose

Anesthesia, Urologic Cancer, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Maltodextrin 12.5%
Water
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring cystectomy, fasting, preoperative carbohydrate treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent. Patients older than 18 years old proposed for radical cystectomy. Exclusion Criteria: American Society of Anesthesiologists (ASA) classification grade: IV Renal failure (creatinine levels above 3 mg/dL or dialysis) Liver failure (Child-Pugh B or higher) Gastroesophageal reflux disease. Gastrointestinal obstruction. Ongoing treatment with corticosteroids. Previous infections within the last 3 months.

Sites / Locations

  • Fundación Pública Andaluza para la Gestión de Investigación de Salud en SevillaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Fasting arm

Water arm

Carbohydrate loading arm

Arm Description

Patients included in the fasting arm will not drink or eat anything after the dinner of the night before the surgery.

Patients included in the water intake arm will drink the same amount of mililiters than the carbohydrate loading drink.

Patients included in the intake arm of carbohydrate loading treatment should take 400ml the night before the intervention and 200ml the two hours before the intervention. The hydrocarbonate drink provided will be Sugarmix (Maltodextrin 12.5%).

Outcomes

Primary Outcome Measures

Insulin resistance
Determinate the insulin resistance measured by the homeostatic model assessment (HOMA) index.

Secondary Outcome Measures

To determine the recovery time of intestinal activity by measuring time to first bowel movement.
Bowel movement
To compare and determine whether there are differences between the incidence of infection of surgical wounds, the incidence of postoperative complications and the length of hospital stay in the three groups of patients undergoing this type of surgery.
Complications
Insulin resistance
Determinate the insulin resistance measured by the homeostatic model assessment

Full Information

First Posted
May 30, 2023
Last Updated
June 17, 2023
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT05913245
Brief Title
Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy
Official Title
Impact of the Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
In recent years, the world of anesthesiology is questioning one of its great dogmas: Are so many hours of strict fasting necessary in patients who are candidates for elective surgeries? The main objective of our clinical trial will be demonstrate whether preoperative oral loading with hydrocarbonate beverages reduces the time of return of intestinal function in the postoperative period compared to water administration and strict fasting in patients undergoing elective radical cystectomy.
Detailed Description
Many anaesthesiology societies now recommend intake of clear fluids (water, tea or coffee without milk, juices without pulp) up to two hours before induction of anaesthesia for most patients undergoing elective surgery. This change the traditional practice of overnight fasting, while reducing thirst in the hours before surgery and seems to attenuate the response to the stress that results from a major operation, such as activation of endocrine and inflammatory systems which leads to tissue catabolism and insulin resistance. Among all the complications, one of the most frequent in patients undergoing mayor surgeries is undoubtedly paralytic ileus. The Enhanced Recovery After Surgery (ERAS) guidelines emphasize the importance of preventing this event. To prevent ileus, prokinetic agents such as metoclopramide are used, which although it has not been shown to shorten the period until the first flatulence or the first peristaltic movement, decrease nausea and vomiting. Chewing gum is another measure that is carried out, since it stimulates peristalsis and this measure if it had significant effects in time until first flatulence and in time until first peristaltic movement. In recent years there has been a great change in the perioperative management of patients who will undergo a radical cystectomy. The weight of traditional perioperative care has been an important barrier to the implementation of Fast Track (FT) protocols, since it is difficult to change a therapeutic strategy that has been carried out for decades. The positive results obtained in colorectal surgery led to Fast Track being implemented in other types of surgery similar to colorectal surgery such as radical cystectomy. Although there is apparently widespread enthusiasm for the implementation of Fast Track protocols, evidence of the use of this type of protocols in cystectomy is not robust, numerous studies claim that there is a big difference between the application of FT and the application of traditional measures in terms of length of hospital stay or complications. Because of this, more large-volume randomized experimental studies of patients are needed. This randomized double blind placebo-controlled trial of preoperative oral carbohydrate (CHO) treatment in patients undergoing elective radical cystectomy will investigate whether this treatment reduced the time of return of intestinal function. Secondary outcomes will be the incidence of infection of surgical wounds, the incidence of postoperative complications, the length of hospital stay and early postoperative fatigue in the three groups of patients undergoing this type of surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Urologic Cancer, Surgery
Keywords
cystectomy, fasting, preoperative carbohydrate treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting arm
Arm Type
No Intervention
Arm Description
Patients included in the fasting arm will not drink or eat anything after the dinner of the night before the surgery.
Arm Title
Water arm
Arm Type
Active Comparator
Arm Description
Patients included in the water intake arm will drink the same amount of mililiters than the carbohydrate loading drink.
Arm Title
Carbohydrate loading arm
Arm Type
Experimental
Arm Description
Patients included in the intake arm of carbohydrate loading treatment should take 400ml the night before the intervention and 200ml the two hours before the intervention. The hydrocarbonate drink provided will be Sugarmix (Maltodextrin 12.5%).
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin 12.5%
Intervention Description
Preoperative Maltodextrin 12.5%
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Preoperative water
Primary Outcome Measure Information:
Title
Insulin resistance
Description
Determinate the insulin resistance measured by the homeostatic model assessment (HOMA) index.
Time Frame
1 Day of surgery
Secondary Outcome Measure Information:
Title
To determine the recovery time of intestinal activity by measuring time to first bowel movement.
Description
Bowel movement
Time Frame
1 week
Title
To compare and determine whether there are differences between the incidence of infection of surgical wounds, the incidence of postoperative complications and the length of hospital stay in the three groups of patients undergoing this type of surgery.
Description
Complications
Time Frame
Up to 30 days
Title
Insulin resistance
Description
Determinate the insulin resistance measured by the homeostatic model assessment
Time Frame
Postoperative day #1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent. Patients older than 18 years old proposed for radical cystectomy. Exclusion Criteria: American Society of Anesthesiologists (ASA) classification grade: IV Renal failure (creatinine levels above 3 mg/dL or dialysis) Liver failure (Child-Pugh B or higher) Gastroesophageal reflux disease. Gastrointestinal obstruction. Ongoing treatment with corticosteroids. Previous infections within the last 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel López-Herrera Rodríguez, PhD
Phone
0034-955012276
Email
dalohero@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Rosso, PhD
Organizational Affiliation
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Official's Role
Study Chair
Facility Information:
Facility Name
Fundación Pública Andaluza para la Gestión de Investigación de Salud en Sevilla
City
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial. Study Protocol, Statistical Analysis Plan, Inform Consent Form, Clinical Study Report and Analytic Code will also be available.
IPD Sharing Time Frame
Immediately following publication and with no end date.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Learn more about this trial

Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy

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