Bladder Cancer Clinical Trial
Official title:
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
NCT number | NCT02145871 |
Other study ID # | 14-069 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 21, 2014 |
Est. completion date | March 14, 2024 |
Verified date | March 2024 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to help us learn what is the best amount of fluid to give to patients during bladder surgery in order to avoid delayed bowel function after surgery, which could prolong hospital stay.
Status | Completed |
Enrollment | 282 |
Est. completion date | March 14, 2024 |
Est. primary completion date | March 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Adults (21 years old or greater) who are able to provide informed consent - Patients who undergo an open, elective radical cystectomy Exclusion Criteria: - Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia - Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test = 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery) - Presence of ascites, because increased abdominal pressure interferes with EV1000 reading accuracy - BMI > 45 or <17, because increased abdominal pressure interferes with EV1000 reading accuracy |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Cancer Center @ Commack | Commack | New York |
United States | Memorial Sloan Kettering Westchester | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of postoperative ileus (POI) | POI will be defined as intolerance of oral intake by postoperative day 5, or the cessation of diet and/or placement of an NGT for clinical signs or symptoms associated with POI, including one or more of the following: nausea, emesis, abdominal bloating or distension, or excessive burping. Rate of ileus will be compared between the treatment groups using the chi-square test. A 95% confidence interval for the difference in ileus rate will also be reported. | 3 years | |
Secondary | complications | Overall rate of grade 2-5 1-year complications, and rate of grade 2-5 gastrointestinal, pulmonary, renal, hematologic and cardiac complications will also be compared using the chi-square test. Based rate of grade 2-5 gastrointestinal, pulmonary, renal, hematologic and cardiac complications will also be compared using the chi-square test. | 1 year post operatively | |
Secondary | compare total volume of fluid | given intraoperatively and during the first 72 hrs postoperatively | the first 72 hours |
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