NCT05913245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

May 30, 2023

Last Update Submit

June 17, 2023

Conditions

AnesthesiaUrologic CancerSurgery

Keywords

cystectomyfastingpreoperative carbohydrate treatment

Outcome Measures

Primary Outcomes (1)

  • Insulin resistance

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

    1 Day of surgery

Secondary Outcomes (3)

  • To determine the recovery time of intestinal activity by measuring time to first bowel movement.

    1 week

  • 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.

    Up to 30 days

  • Insulin resistance

    Postoperative day #1

Study Arms (3)

Fasting arm

NO INTERVENTION

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

Water arm

ACTIVE COMPARATOR

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

Other: Water

Carbohydrate loading arm

EXPERIMENTAL

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%).

Dietary Supplement: Maltodextrin 12.5%

Interventions

Maltodextrin 12.5%DIETARY_SUPPLEMENT

Preoperative Maltodextrin 12.5%

Carbohydrate loading arm
WaterOTHER

Preoperative water

Water arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Patients older than 18 years old proposed for radical cystectomy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Pública Andaluza para la Gestión de Investigación de Salud en Sevilla

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Urologic NeoplasmsFasting

Interventions

Water

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Clara Rosso, PhD

    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    STUDY CHAIR

Central Study Contacts

Daniel López-Herrera Rodríguez, PhD

CONTACT

0034-955012276dalohero@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 22, 2023

Study Start

March 30, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication and with no end date.
Access Criteria
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations

ES(1)