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Completed

NCT Number: NCT03126162

Postoperative Bladder Testing After 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

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee-Womens Hospital, UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InstilIing normal saline into bladder

Procedure

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 catheter

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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