Optimal Management of Urinary Catheter in Gyn Onc

March 15, 2023 updated by: Eav Lim, WellSpan Health

Optimal Management and Timing of Removal of Urinary Catheter Following Pelvic Surgery by the Gynecologic Oncology Surgeon

This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Wellspan York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients who meets the eligibility criteria, undergoing pelvic surgery by a gynecologic oncologist. Simple and radical procedures included.

Description

Inclusion Criteria:

  • Age above 18
  • female gender
  • undergoing pelvic surgery for benign or malignant indications by a gynecologic oncologist

Exclusion Criteria:

  • Age less than 18 years of age at the time of surgery
  • pregnant
  • individual is a prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Minimal invasive surgery
removal of urinary catheter postoperatively
Other: Early removal of urinary catheter postoperatively
removal of urinary catheter less than 24 hours after surgery
Other: Late removal of urinary catheter postoperatively
removal of urinary catheter greater than 24 hours after surgery
Laparotomy
removal of urinary catheter postoperatively
Other: Early removal of urinary catheter postoperatively
removal of urinary catheter less than 24 hours after surgery
Other: Late removal of urinary catheter postoperatively
removal of urinary catheter greater than 24 hours after surgery
Simple surgery
removal of urinary catheter postoperatively
Other: Early removal of urinary catheter postoperatively
removal of urinary catheter less than 24 hours after surgery
Other: Late removal of urinary catheter postoperatively
removal of urinary catheter greater than 24 hours after surgery
Radical surgery
removal of urinary catheter postoperatively
Other: Early removal of urinary catheter postoperatively
removal of urinary catheter less than 24 hours after surgery
Other: Late removal of urinary catheter postoperatively
removal of urinary catheter greater than 24 hours after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary retention rate after urinary catheter removal postoperatively
Time Frame: 30 days after surgery
urinary retention rate will be measured as need for re-catheterization postoperatively
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WellSpan Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Actual)

March 14, 2023

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1946054-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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