Bladder Cancer
Conditions
Keywords
Radical Cystectomy, Perioperative Fluid Management, EV1000, 14-069
Brief summary
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.
Interventions
OTHERfluid management guided by the EV1000
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative ileus (POI) | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications | 1 year post operatively | 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. |
| compare total volume of fluid | the first 72 hours | given intraoperatively and during the first 72 hrs postoperatively |
Countries
United States
Outcome results
None listed