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

Not Applicable

Completed

• Conditions: Urinary Retention; Hysterectomy; Minimally Invasive Surgical Procedure
• Interventions: Other: Active voiding trial

• Registration Number: NCT04487600
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Voiding Trial	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.

Primary Outcome Measures

Name	Time	Method
length of hospital stay	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

Secondary Outcome Measures

Name	Time	Method
catheter replacement	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
overnight admission	within 1 day following surgical procedure	planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)
time to void	within 12 hours (720 minutes) following surgical procedure	Time (minutes) from Foley catheter removal to adequate voiding
discomfort with voiding trial	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.