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

NCT ID: NCT04098809

Last Updated: 2019-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2018-11-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Catheter 16 French

16 French urinary catheter

Group Type ACTIVE_COMPARATOR

16 French urinary catheter

Intervention Type DEVICE

16 French urinary catheter

Catheter 20 French

20 French urinary catheter

Group Type ACTIVE_COMPARATOR

20 French urinary catheter

Intervention Type DEVICE

20 French urinary catheter

Interventions

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16 French urinary catheter

16 French urinary catheter

Intervention Type DEVICE

20 French urinary catheter

20 French urinary catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Corman, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

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Virginia Mason Medical center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB17-095

Identifier Type: -

Identifier Source: org_study_id