A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 130
- Primary Endpoint
- length of hospital stay
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
Voiding trial protocols for each group (AVT and PVT) as well as data collection sheets were stored in sequentially numbered, opaque, sealed envelopes which were assigned after enrollment and were opened in the operating room at the completion of surgery by the surgical assistant. Attending surgeons and investigators were blinded to the individual patient study assignment. Due to the nature of the study, participants were not masked to their intervention.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
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
- catheter replacement(within 24 hours (1440 minutes) following surgical procedure)
- overnight admission(within 1 day following surgical procedure)
- time to void(within 12 hours (720 minutes) following surgical procedure)
- discomfort with voiding trial(within 12 hours (720 minutes) following surgical procedure)
Investigators
Colleen Marie Feltmate, MD
BWPO Physician
Brigham and Women's Hospital