Postoperative Bladder Testing After Total Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Enhanced Recovery After Surgery; Laparoscopic Hysterectomy
• Interventions: Procedure: InstilIing normal saline into bladder; Procedure: Removal of foley catheter

• Registration Number: NCT03126162
• Lead Sponsor: University of Pittsburgh

Brief 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

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 Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Start: 2017-06-08
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-02
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder Backfilled group	Removal of foley catheter	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
Control group	Removal of foley catheter	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.
Bladder Backfilled group	InstilIing normal saline into bladder	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

Primary Outcome Measures

Name	Time	Method
Time to first spontaneous void	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 Outcome Measures

Name	Time	Method
Time to discharge from the hospital after same-day laparoscopic hysterectomy	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)

Trial Locations

Locations (1)

Magee-Womens Hospital, UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States