Clinical trial NCT04487600: The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial
Official title: A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimally Invasive Surgical Procedure
Hysterectomy
Urinary Retention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who were scheduled to undergo a same day discharge laparoscopic hysterectomy were assessed for eligibility to participate in this study. A computer generated blocked randomization schema was utilized with alternating block sizes to determine study groups. Participants were randomized 1:1 to each study group (active voiding trial vs. passive voiding trial). There was no cross-over between arms. If the participant did not receive the study intervention as allocated they were withdrawn from the study.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: length of hospital stay
timeFrame: 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)
Secondary outcomes:
measure: time to void
timeFrame: within 12 hours (720 minutes) following surgical procedure
measure: catheter replacement
timeFrame: within 24 hours (1440 minutes) following surgical procedure
measure: discomfort with voiding trial
timeFrame: within 12 hours (720 minutes) following surgical procedure
measure: overnight admission
timeFrame: within 1 day following surgical procedure
Other outcomes:
Locations:
Study officials:
References:
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