Postoperative Bladder Testing After Total Laparoscopic Hysterectomy

June 2, 2018 updated by: Suketu Mansuria, University of Pittsburgh

A Randomized, Controlled Trial Evaluating 2 Techniques of Postoperative Bladder Testing for Patients Undergoing Same-day Total Laparoscopic Hysterectomy

The objective of this study is to determine if backfilling the bladder immediately post-operatively, prior to removal of the foley catheter, in patients undergoing same-day total laparoscopic hysterectomy will hasten time to first spontaneous void and time to discharge

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, a paradigm shift from traditional perioperative care models to "Enhanced Recovery After Surgery (ERAS)" has taken place across a wide range of surgical subspecialties including minimally-invasive gynecologic surgery. Many gynecologic procedures that once required hospital admission are now being performed as outpatient procedures. To optimize same-day discharge through the ERAS pathways, protocols call for early removal of urinary catheters following gynecologic surgery. Studies in urogynecologic literature have shown that a backfill-assisted voiding trial is superior to a spontaneous voiding trial in patients undergoing transvaginal surgery. However, there are limited studies published in literature focusing on minimally invasive gynecologic procedures, specifically laparoscopic hysterectomies. A successful spontaneous voiding trial is usually a postoperative criteria prior to discharge after same-day total laparoscopic hysterectomy. Through this randomized controlled trial, the investigators aim to compare two techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy. This study would provide valuable data on improved measures for predicting voiding efficiency, time to first void, and time to discharge for patients undergoing same-day total laparoscopic hysterectomies. Ultimately, the investigators predict that backfilling the bladder immediately postoperatively, prior to removal of the foley catheter, will hasten time to first spontaneous void and reduce the amount of time spent in the recovery room.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

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
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital, UPMC

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-75 years of age
  • Ability to comprehend English
  • Women undergoing same-day laparoscopic hysterectomy through the Enhanced Recovery after Surgery (ERAS) protocol at Magee-Womens Hospital (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy)

Exclusion Criteria:

  • Women who are unable to give informed consent
  • History of prior or concurrent urogynecologic procedures performed including mid-urethral sling, rectocele/cystocele repairs, burch urethropexy, sacrospinous ligament fixation, uterosacral vaginal vault suspension, sacrocolpopexy
  • History of multiple sclerosis
  • Known malignancy of the bladder
  • Bladder or ureteral injury that occurred intra-operatively
  • Women who are being treated for an active urinary tract infection at the time of surgery
  • Women admitted overnight who fail to go home the same day after total laparoscopic hysterectomy

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bladder Backfilled group
Subjects randomized to the bladder backfilled group (Group A) will have 200 mL of normal saline instilled into their bladders prior to removal of the foley catheter. The foley catheter will subsequently be removed
Procedure: InstilIing normal saline into bladder
Backfilling the bladder with 200 mL of normal saline immediately postoperatively, prior to foley catheter removal, after same-day total laparoscopic hysterectomy can potentially increase time to first spontaneous void and time to discharge.
Procedure: Removal of foley catheter
Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy
Placebo Comparator: Control group
Subjects randomized to the control group (Group B) will just have their foley catheters removed at the end of the surgery. This is routinely done post-operatively after routine gynecologic surgery.
Procedure: Removal of foley catheter
Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first spontaneous void
Time Frame: From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks
Our primary hypothesis is that patients who undergo same-day total laparoscopic hysterectomy that are randomized into the group who have their bladders backfilled with 200 cc normal saline post-operatively, prior to removal of the foley catheter will have a shorter time to first spontaneous void.
From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to discharge from the hospital after same-day laparoscopic hysterectomy
Time Frame: From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks
We hypothesize that patients who undergo same-day total laparoscopic hysterectomy that are randomized into the group who have their bladders filled with 200 cc normal saline post-operatively, prior to removal of the foley catheter, will have a shorter time to discharge. We will be recording the amount of time patients spend in the post-anesthesia care unit (PACU)
From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative urinary retention rates
Time Frame: From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks
We will also evaluate the rates of postoperative urinary retention in patients who undergo same-day total laparoscopic hysterectomy through the Enhanced Recovery After Surgery (ERAS) protocol.
From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Suketu Mansuria, MD, University of Pittsburgh Medical Center

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)

June 8, 2017

Primary Completion (Actual)

May 4, 2018

Study Completion (Actual)

May 4, 2018

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 2, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO17010292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Authorized representatives of Magee-Womens Hospital of UPMC may have access to research data/documents for the purpose of research. These 'external persons' may include other investigators from both inside and outside Magee-Womens Hospital of UPMC who are conducting similar research after IRB approval. The data that would be shared would be de-identified research data/materials. The investigators currently do not have a data sharing plan with individuals other than the current investigators/research staff involved with this research project. Should the investigators decide to share data in the future, the investigators will contact the Office of Research before sharing de-identified research data/materials to determine whether an agreement needs to be executed.

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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