NCT02741531

Brief Summary

The purpose of this study is to determine if partially filling the bladder after laparoscopic/robotic gynecologic surgery (for benign disease) shortens the time required to spontaneously void for patients to determine if this subsequently shortens patient stay times in the Post Anesthesia Care Unit (PACU) following surgery. This intervention would be compared to the current standard of care, which involves removing the patient's Foley catheter with an empty bladder and then giving the patient up to 6 hours to void in the PACU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2017

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

March 30, 2016

Last Update Submit

May 18, 2023

Conditions

HysterectomyMyomectomy

Outcome Measures

Primary Outcomes (1)

  • Time to Void

    the time (in minutes) between when the patient's foley is removed and when the patient is able to void in the PACU.

    peri-operative

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in this group will have their bladder filled with 150 cubic centimeters (cc) of saline solution prior to being moved to the PACU.

Other: Bladder filled with saline solutionOther: saline solution

Control

NO INTERVENTION

patients in this group will have their bladders drained completely prior to being moved to the PACU as is the current standard of care.

Interventions

Bladder filled with saline solutionOTHER

Patients in this arm will have their bladders filled with 150 cc of saline solution.

Intervention
saline solutionOTHER

Saline solution will be used to partially fill patients' bladders

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale or person with female sexual reproduction organs
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hysterectomy or myomectomy planned for a benign gynecologic reason. (This means that there is no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain. Benign reason for myomectomy would be fibroids)
  • Patient is scheduled to have surgery with one of the minimally invasive gynecologic surgeons at George Washington University Hospital (GWUH)
  • Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH) or robotic assisted or laparoscopic myomectomy.
  • Patient is capable of informed consent.
  • The patient has no baseline urinary disease.

You may not qualify if:

  • Hysterectomy or myomectomy is indicated for malignancy
  • Hysterectomy or myomectomy is not being performed via robotic or laparoscopic method
  • Patient is not capable of providing informed consent
  • Patient has urinary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

  • Moawad G, Tyan P, Marfori C, Abi Khalil E, Park D. Effect of postoperative partial bladder filling after minimally invasive hysterectomy on postanesthesia care unit discharge and cost: a single-blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Apr;220(4):367.e1-367.e7. doi: 10.1016/j.ajog.2018.12.034. Epub 2019 Jan 9.

    PMID: 30639089DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 18, 2016

Study Start

March 1, 2016

Primary Completion

July 27, 2017

Study Completion

July 27, 2017

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

US(1)