Bladder CancerNCT01489800
The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
A study testing Clear liquid diet in people with Bladder Cancer and Complications, run by Columbia University at 2 sites in United States.
Trial summary
Complications after radical cystectomy for bladder cancer range from 30-40%, many of which are related to bowel function. Patients usually wait to eat until return of bowel function, although there is evidence that after primary intestinal or colonic surgery, patients may take food ad lib immediately, and that this is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Complications
- What is being tested?
- Clear liquid diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jan 2015
- 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
- Age >=18
- Bladder cancer
- Elect radical cystectomy and urinary diversion as treatment
- Able to provide informed consent
Who cannot join
- Radical cystectomy for reason other than bladder cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Hospital - Cornell
New York, New York, 10021
Columbia Univeristy Medical Center
New York, New York, 10032
About this study
Complications after radical cystectomy for bladder cancer range from 30-40%, many of which are related to bowel function. Patients usually wait to eat until return of bowel function, although there is evidence that after primary intestinal or colonic surgery, patients may take food ad lib immediately, and that this is is associated with lower complication rate and shorter length of stay. The investigators hypothesize that early access to oral enteral nutrition (food at will) after cystectomy and urinary diversion will reduce the complication rate both in-hospital and within 90 days after hospital discharge.
Read the detailed description
Subjects preparing to undergo radical cystectomy and urinary diversion for bladder cancer that provide informed consent will be randomized into 1 of 2 study arms. The experimental arm will be offered clear liquid diet 24 hours after extubation and advanced to regular diet 24 hours later if clear liquids are well tolerated. The standard/control arm will receive a clear liquid diet at the time of return of bowel function, determined by significant flatus or bowel movements.
Information related to time to return of bowel function, frequency of nausea/vomiting, hospital complications and length of stay will be recorded. Patients will be followed with phone calls and chart reviews at 30, 60 and 90 days following surgery. Additional hospital admissions and/or complications will be determined with those phone calls.
- Conditions
- Bladder Cancer, Complications
- Being tested
- Clear liquid diet
- Keywords
- feeding, complications, radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear liquid dietBehavioural
Also called liquid diet
clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Early Feeding | Experimental | Introduction of clear liquid diet 24 hours after extubation with advancement to regular diet 24 hours thereafter if there is no significant nausea or vomiting. Receives: Behavioral: Clear liquid diet |
| Control Feeding | No intervention | Standard of care with introduction of clear liquid diet at time of return of bowel function as determined by flatus. Advancement to full diet 24 later if clear diet well tolerated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
powered to detect 50% reduction in complication rate, from 40% down to 20%
Measured: 90 day
Secondary outcomes (1)
Primary Hospital Length of Stay
time from admission for surgery until discharge after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell C. Benson, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489800
- Sponsor's protocol ID
- AAAI0046
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2011
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang SS, Cookson MS, Baumgartner RG, Wells N, Smith JA Jr. Analysis of early complications after radical cystectomy: results of a collaborative care pathway. J Urol. 2002 May;167(5):2012-6.
PubMed 11956429Lassen K, Kjaeve J, Fetveit T, Trano G, Sigurdsson HK, Horn A, Revhaug A. Allowing normal food at will after major upper gastrointestinal surgery does not increase morbidity: a randomized multicenter trial. Ann Surg. 2008 May;247(5):721-9. doi: 10.1097/SLA.0b013e31815cca68.
PubMed 18438106Pruthi RS, Nielsen M, Smith A, Nix J, Schultz H, Wallen EM. Fast track program in patients undergoing radical cystectomy: results in 362 consecutive patients. J Am Coll Surg. 2010 Jan;210(1):93-9. doi: 10.1016/j.jamcollsurg.2009.09.026. Epub 2009 Oct 28.
PubMed 20123338Deibert CM, Silva MV, RoyChoudhury A, McKiernan JM, Scherr DS, Seres D, Benson MC. A Prospective Randomized Trial of the Effects of Early Enteral Feeding After Radical Cystectomy. Urology. 2016 Oct;96:69-73. doi: 10.1016/j.urology.2016.06.045. Epub 2016 Jul 8.
PubMed 27402372
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT01489800
- Acronym / sponsor ID
- AAAI0046
- Conditions
- Bladder Cancer, Complications
- Keywords
- feeding, complications, radical cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Dec 2011 (estimated)
- 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.
Complications after radical cystectomy for bladder cancer range from 30-40%, many of which are related to bowel function. Patients usually wait to eat until return of bowel function, although there is evidence that after primary intestinal or colonic surgery, patients may take food ad lib immediately, and that this is is associated with lower complication rate and shorter length of stay. The investigators hypothesize that early access to oral enteral nutrition (food at will) after cystectomy and urinary diversion will reduce the complication rate both in-hospital and within 90 days after hospital discharge.
Detailed description
Subjects preparing to undergo radical cystectomy and urinary diversion for bladder cancer that provide informed consent will be randomized into 1 of 2 study arms. The experimental arm will be offered clear liquid diet 24 hours after extubation and advanced to regular diet 24 hours later if clear liquids are well tolerated. The standard/control arm will receive a clear liquid diet at the time of return of bowel function, determined by significant flatus or bowel movements.
Information related to time to return of bowel function, frequency of nausea/vomiting, hospital complications and length of stay will be recorded. Patients will be followed with phone calls and chart reviews at 30, 60 and 90 days following surgery. Additional hospital admissions and/or complications will be determined with those phone calls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Feeding | Experimental | Behavioral: Clear liquid dietIntroduction of clear liquid diet 24 hours after extubation with advancement to regular diet 24 hours thereafter if there is no significant nausea or vomiting. |
| Control Feeding | No intervention | –Standard of care with introduction of clear liquid diet at time of return of bowel function as determined by flatus. Advancement to full diet 24 later if clear diet well tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18
- Bladder cancer
- Elect radical cystectomy and urinary diversion as treatment
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Radical cystectomy for reason other than bladder cancer
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 |
|---|---|---|
| Clear liquid dietAlso: liquid dietclear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm. | Behavioural | Early Feeding |
Primary outcome
Complication rate
Time frame: 90 day
powered to detect 50% reduction in complication rate, from 40% down to 20%
1 secondary outcome
Primary Hospital Length of Stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 11956429Chang SS, Cookson MS, Baumgartner RG, Wells N, Smith JA Jr. Analysis of early complications after radical cystectomy: results of a collaborative care pathway. J Urol. 2002 May;167(5):2012-6.
- Background: PubMed 18438106Lassen K, Kjaeve J, Fetveit T, Trano G, Sigurdsson HK, Horn A, Revhaug A. Allowing normal food at will after major upper gastrointestinal surgery does not increase morbidity: a randomized multicenter trial. Ann Surg. 2008 May;247(5):721-9. doi: 10.1097/SLA.0b013e31815cca68.
- Background: PubMed 20123338Pruthi RS, Nielsen M, Smith A, Nix J, Schultz H, Wallen EM. Fast track program in patients undergoing radical cystectomy: results in 362 consecutive patients. J Am Coll Surg. 2010 Jan;210(1):93-9. doi: 10.1016/j.jamcollsurg.2009.09.026. Epub 2009 Oct 28.
- Results publication: PubMed 27402372Deibert CM, Silva MV, RoyChoudhury A, McKiernan JM, Scherr DS, Seres D, Benson MC. A Prospective Randomized Trial of the Effects of Early Enteral Feeding After Radical Cystectomy. Urology. 2016 Oct;96:69-73. doi: 10.1016/j.urology.2016.06.045. Epub 2016 Jul 8.
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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.
Mitchell C. Benson, M.D. principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear liquid diet in people with Bladder Cancer and Complications, run by Columbia University at 2 sites in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489800, which also lists 4 linked publications.
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 17 Aug 2021.