Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
Recruitment status was Recruiting
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study|
- urinary retention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Procedure: Early urinary catheter removal
All patients undergoing anterior resection (rectosigmoid), low anterior resection, abdomino-perineal resection, total proctocolectomy with ileal pouch-anal anastomosis, sigmoid colectomy, and coloanal anastomosis will be included in the study. All patients will undergo standard pre-operative work-up prior to the operation. As part of the operative note, the level of the anastomosis must be documented.
- All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
- All patients will undergo bladder ultrasound prior to catheter removal.
- All patients will undergo bladder ultrasound by nursing staff six hours after catheter removal, and after voiding the first time after catheter removal, or if the patient experiences symptoms of urinary retention.
6. Patients who meet definition of urinary retention (>100cc post-void residual) will undergo intermittent straight catheterization every six hours or with symptoms. For those who refuse intermittent straight catheterization, a indwelling urinary catheter will be inserted and left in for 24 hours before removal.
7. For patients who have low urine output indicating under-resuscitation, indwelling catheters will be re-inserted and removed when ongoing resuscitation measures are completed.
8. For patients who are actively undergoing fluid resuscitation on post-operative day 3 will not have their urinary catheters removed until resuscitation and monitoring is complete.
9. Patients who report symptoms of benign prostatic hypertrophy (BPH) and/or are already on medications for BPH will be continued on those medications starting on post-operative day 1.
10. Patients who have persistent urinary retention when they are otherwise ready to be discharged home will be sent home with a leg bag and follow up in urology clinic for voiding trial in 1-2 weeks.
11. Urinalysis/urine culture will be performed for symptomatic patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186237
|Contact: Moe Jalali, MDfirstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Moe Jalali, MD 650-724-4023 email@example.com|
|Contact: Cancer Clinical Trials Office (650) 498-7061|
|Principal Investigator: Mark Lane Welton, MD|
|Sub-Investigator: Kim Felder Rhoads, MD|
|Sub-Investigator: Cindy Kin, MD|
|Principal Investigator:||Mark Lane Welton||Stanford University|