The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial

July 24, 2020 updated by: Colleen Marie Feltmate, MD, Brigham and Women's Hospital

A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy

The aim of this study is to investigate the impact of an active voiding trial compared to a passive voiding trial on time to discharge following a planned same day discharge laparoscopic hysterectomy. The investigators hypothesize that performing an active voiding trial will assess urinary function and lead to a reduction in length of stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following laparoscopic surgery with hysterectomy, there is no standard method for assuring urinary function prior to discharge. Total laparoscopic hysterectomy (TLH) has been demonstrated to be safe with a reduction in post-operative morbidity and length of hospital stay with no difference in cancer related outcomes in endometrial cancer. Furthermore, the investigators have demonstrated that following the adoption of same day discharge, there was no difference in composite complication rates or readmissions. Awaiting a passive void trial may impact time to discharge as well as same day discharge; however, this has not been clearly studied in this patient population. The aim of this study is to determine the difference in time to discharge following an active voiding trial with bladder backfill in the post-operative recovery unit compared to a passive voiding trial with removal of the Foley catheter in the operating room at the end of the procedure. Secondary outcomes include time to void, catheter replacement, discomfort with the voiding trial, and overnight admission.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic oncology surgeon for either benign or malignant disease
  • planned same day discharge surgery

Exclusion Criteria:

  • history of significant urinary dysfunction (such as home catheterization) or neurologic dysfunction precluding spontaneous voiding
  • bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of bilateral parametria)
  • surgical cases converted to laparotomy or open surgery
  • Surgical or medical contra-indications (based on the surgeons or anesthesiologists' recommendations) to same day discharge requiring inpatient admission

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Voiding Trial
At the completion of surgery, a Foley catheter was left in place. When the patient was determined to be ambulatory by the recovery room nurse, the bladder was backfilled with 300cc of sterile normal saline. Voiding 200cc or (2/3) of the backfill amount was considered passing.
Other: Active voiding trial
No Intervention: Passive Voiding Trial
At the completion of surgery, a Foley catheter was removed in the operating room. Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice. At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)
Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit
within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to void
Time Frame: within 12 hours (720 minutes) following surgical procedure
Time (minutes) from Foley catheter removal to adequate voiding
within 12 hours (720 minutes) following surgical procedure
catheter replacement
Time Frame: within 24 hours (1440 minutes) following surgical procedure
failed trial of void (unable to void adequate volume 2/3rd of backfill or 200cc) requiring replacement of a Foley catheter for post-operative urinary retention
within 24 hours (1440 minutes) following surgical procedure
discomfort with voiding trial
Time Frame: within 12 hours (720 minutes) following surgical procedure
average pain scale as measured by Wong-Baker FACES Pain Rating Scale ranging from 0 to 10 with 0 being no pain and 10 being the worst pain.
within 12 hours (720 minutes) following surgical procedure
overnight admission
Time Frame: within 1 day following surgical procedure
planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)
within 1 day following surgical procedure

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2017

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

August 4, 2017

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P000902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified patient data and voiding protocols will be made available upon request via email to other researchers

IPD Sharing Time Frame

Data will be available upon request until the time of publication.

IPD Sharing Access Criteria

requests should be made via the study contact email.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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