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Laparoscopic HysterectomyNCT03126162

Postoperative Bladder Testing After Total Laparoscopic Hysterectomy

A study testing InstilIing normal saline into bladder and Removal of foley catheter in people with Laparoscopic Hysterectomy and Enhanced Recovery After Surgery, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
InstilIing normal saline into bladder and Removal of foley catheter
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
1 siteUnited States
Study dates
8 Jun 2017to 4 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Magee-Womens Hospital, UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
InstilIing normal saline into bladder, Removal of foley catheter
Keywords
minimally invasive gynecologic surgery, same-day discharge, bladder testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InstilIing normal saline into bladderProcedure or surgery

    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.

  • Removal of foley catheterProcedure or surgery

    Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy

Study groups in NCT03126162
Study groupRoleWhat they receive
Bladder Backfilled groupExperimentalSubjects 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
Receives: Procedure: InstilIing normal saline into bladder; Procedure: Removal of foley catheter
Control groupPlacebo comparatorSubjects 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.
Receives: Procedure: Removal of foley catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first spontaneous void

    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.

    Measured: From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Secondary outcomes (1)

  1. Time to discharge from the hospital after same-day laparoscopic hysterectomy

    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)

    Measured: From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start8 Jun 2017
  3. Primary completion4 May 2018
  4. Study completion4 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy
Masking
Single blind
Who is masked
Participant
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126162
Sponsor's protocol ID
PRO17010292
Status last verified
Jun 2018
First submitted
14 Apr 2017
Last updated
6 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.

    PubMed 27521884

  • Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries: Effect of Care Standardization. Obstet Gynecol. 2016 Sep;128(3):457-66. doi: 10.1097/AOG.0000000000001555.

    PubMed 27500337

  • Kalogera E, Bakkum-Gamez JN, Jankowski CJ, Trabuco E, Lovely JK, Dhanorker S, Grubbs PL, Weaver AL, Haas LR, Borah BJ, Bursiek AA, Walsh MT, Cliby WA, Dowdy SC. Enhanced recovery in gynecologic surgery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):319-328. doi: 10.1097/AOG.0b013e31829aa780.

    PubMed 23969801

  • Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.

    PubMed 18060956

  • Chao L, Mansuria S. Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):879-887. doi: 10.1097/AOG.0000000000003191.

    PubMed 30969209

Questions about this trial

What is this clinical trial studying?

A study testing InstilIing normal saline into bladder and Removal of foley catheter in people with Laparoscopic Hysterectomy and Enhanced Recovery After Surgery, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126162, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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