NCT Number: NCT04487600
The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial
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.
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Notify MeKey information
Conditions
Age range
18 year–99 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
length of hospital stay
Time frame: 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 outcomes
-
time to void
Time frame: within 12 hours (720 minutes) following surgical procedure
Time (minutes) from Foley catheter removal to adequate voiding
-
catheter replacement
Time frame: 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
-
discomfort with voiding trial
Time frame: 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.
-
overnight admission
Time frame: within 1 day following surgical procedure
planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)
Sponsors and collaborators
Lead sponsor
Brigham and Women's Hospital
Other
Registry information
Official study title
A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jul 27, 2020
- Registry last updated
- Nov 24, 2025
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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