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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy

Conditions
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Minimally Invasive Surgical Procedure, Hysterectomy, Urinary Retention

Intervention / Treatment
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* Other: Active voiding trial


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Voiding Trial<br>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. | Other: Active voiding trial<br> <br> |
| No Intervention: Passive Voiding Trial<br>At the completion of surgery, a Foley catheter was removed in the operating room. Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice. At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to void | Time (minutes) from Foley catheter removal to adequate voiding | within 12 hours (720 minutes) following surgical procedure | 
| catheter replacement | 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 | within 24 hours (1440 minutes) following surgical procedure | 
| discomfort with voiding trial | 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. | within 12 hours (720 minutes) following surgical procedure | 
| overnight admission | planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU) | within 1 day following surgical procedure |