AnesthesiaNCT05913245
Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy
A study testing Maltodextrin 12.5% and Water in people with Anesthesia and Urologic Cancer, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Urologic Cancer, Surgery
- What is being tested?
- Maltodextrin 12.5% and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients older than 18 years old proposed for radical cystectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundación Pública Andaluza para la Gestión de Investigación de Salud en Sevilla
Seville, 41013
About this study
Official title: Impact of the Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy: a Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Anesthesia, Urologic Cancer, Surgery
- Being tested
- Maltodextrin 12.5%, Water
- Keywords
- cystectomy, fasting, preoperative carbohydrate treatment
- Medical subject headings
- Urologic Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin 12.5%Dietary supplement
Preoperative Maltodextrin 12.5%
WaterOther
Preoperative water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%). Receives: Dietary Supplement: Maltodextrin 12.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Determinate the insulin resistance measured by the homeostatic model assessment (HOMA) index.
Measured: 1 Day of surgery
Secondary outcomes (3)
To determine the recovery time of intestinal activity by measuring time to first bowel movement.
Bowel movement
Measured: 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.
Complications
Measured: Up to 30 days
Insulin resistance
Determinate the insulin resistance measured by the homeostatic model assessment
Measured: Postoperative day #1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 Mar 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel López-Herrera Rodriguez, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Investigators
- Clara Rosso, PhD, Study chair, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913245
- Sponsor's protocol ID
- 1738-N-22
- Status last verified
- Jun 2023
- First submitted
- 30 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Preoperative Carbohydrate Loading for Enhancing Recovery After Radical Cystectomy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05913245
- Acronym / sponsor ID
- 1738-N-22
- Conditions
- Anesthesia, Urologic Cancer, Surgery
- Keywords
- cystectomy, fasting, preoperative carbohydrate treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: WaterPatients included in the water intake arm will drink the same amount of mililiters than the carbohydrate loading drink. |
| Carbohydrate loading arm | Experimental | Dietary Supplement: Maltodextrin 12.5%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%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent.
- Patients older than 18 years old proposed for radical cystectomy.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin 12.5%Preoperative Maltodextrin 12.5% | Dietary supplement | Carbohydrate loading arm |
| WaterPreoperative water | Other | Water arm |
Primary outcome
Insulin resistance
Time frame: 1 Day of surgery
Determinate the insulin resistance measured by the homeostatic model assessment (HOMA) index.
3 secondary outcomes
To determine the recovery time of intestinal activity by measuring time to first bowel movement.
Time frame: 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.
Time frame: Up to 30 days
Insulin resistance
Time frame: Postoperative day #1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Rosso, PhD study chair
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin 12.5% and Water in people with Anesthesia and Urologic Cancer, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel López-Herrera Rodríguez, PhD (0034-955012276, dalohero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: 1 Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.