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

Mass General Brigham

Status: Completed

Conditions: Urinary Retention; Minimally Invasive Surgical Procedure; Hysterectomy

Treatments: Other: Active voiding trial

Study type: Interventional

Funder types: Other

Identifiers

NCT04487600

2015P000902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Active Voiding Trial

Experimental group

Description:

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.

Treatment:

Other: Active voiding trial

Passive Voiding Trial

No Intervention group

Description:

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.