Optimal Management of Urinary Catheter in Gyn Onc

NCT05538273 | Withdrawn

• 1 other identifier: 1946054-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Retention

Keywords

urinary retention; postoperative; urinary complications; pelvic surgery; hysterectomy; gynecologic oncology

Outcome Measures

Primary Outcomes (1)

• Urinary retention rate after urinary catheter removal postoperatively

  urinary retention rate will be measured as need for re-catheterization postoperatively

  30 days after surgery

Study Arms (4)

Minimal invasive surgery

removal of urinary catheter postoperatively

Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively

Laparotomy

removal of urinary catheter postoperatively

Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively

Simple surgery

removal of urinary catheter postoperatively

Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively

Radical surgery

removal of urinary catheter postoperatively

Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively

Interventions

Early removal of urinary catheter postoperatively OTHER

removal of urinary catheter less than 24 hours after surgery

Laparotomy; Minimal invasive surgery; Radical surgery; Simple surgery

Late removal of urinary catheter postoperatively OTHER

removal of urinary catheter greater than 24 hours after surgery

Laparotomy; Minimal invasive surgery; Radical surgery; Simple surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Director, Gynecology Oncology

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: September 8, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)