Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
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About
This study is designed to assess the effect of catheter size on postoperative catheter pain, urinary continence, urinary flow rates, post void residuals, International Prostate Symptom Scores (IPSS), and Quality of Life (QoL) score, as well as long term complications after robotic assisted laparoscopic prostatectomy.
Full description
Subjects identified to receive a robotic assisted laparoscopic prostatectomy.were randomized to either a 16 French or 20 French catheter at the completion of the prostatectomy. All prostatectomies were performed by one of three surgeons at the investigator's institution. Preoperative demographics and operative data were recorded for each group. Catheters remained in place for 7-14 days. Subjects were asked on postoperative day 7 to report their catheter-related pain and amount of opioid medication used. Urinary symptoms and quality of life scores and pads per day were recorded at 6 weeks and 12 weeks post-operatively.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Identified as candidate for robotic assisted laparoscopic prostatectomy
Exclusion criteria
- Having filled a prescription for opioid medication in last 2 months.
- Known latex allergy
- Known pre-operatively that catheter placement will exceed 14 days
- History of pelvic radiation
- Significant deviation from normal operative protocol
Trial design
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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