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

Brigham and Women's Hospital130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

130

Conditions

Minimally Invasive Surgical Procedure Hysterectomy Urinary Retention

Interventions

Active voiding trialOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (minutes) from the completion of surgery to discharge from the post-operative recovery unit

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)

Secondary Outcomes

time to void

Time (minutes) from Foley catheter removal to adequate voiding

Time frame: 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

Time frame: 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.

Time frame: within 12 hours (720 minutes) following surgical procedure

overnight admission

planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)

Time frame: within 1 day following surgical procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.