Prostate Cancer Clinical Trial

Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy

Summary

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.

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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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

52

Study ID:

NCT04098809

Recruitment Status:

Completed

Sponsor:

Benaroya Research Institute

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There is 1 Location for this study

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Virginia Mason Medical center
Seattle Washington, 98101, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

52

Study ID:

NCT04098809

Recruitment Status:

Completed

Sponsor:


Benaroya Research Institute

How clear is this clinincal trial information?

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