Enhanced Recovery After Surgery, Laparoscopic Hysterectomy
Conditions
Keywords
minimally invasive gynecologic surgery, same-day discharge, bladder testing
Brief summary
The objective of this study is to determine if backfilling the bladder immediately post-operatively, prior to removal of the foley catheter, in patients undergoing same-day total laparoscopic hysterectomy will hasten time to first spontaneous void and time to discharge
Detailed description
In recent years, a paradigm shift from traditional perioperative care models to Enhanced Recovery After Surgery (ERAS) has taken place across a wide range of surgical subspecialties including minimally-invasive gynecologic surgery. Many gynecologic procedures that once required hospital admission are now being performed as outpatient procedures. To optimize same-day discharge through the ERAS pathways, protocols call for early removal of urinary catheters following gynecologic surgery. Studies in urogynecologic literature have shown that a backfill-assisted voiding trial is superior to a spontaneous voiding trial in patients undergoing transvaginal surgery. However, there are limited studies published in literature focusing on minimally invasive gynecologic procedures, specifically laparoscopic hysterectomies. A successful spontaneous voiding trial is usually a postoperative criteria prior to discharge after same-day total laparoscopic hysterectomy. Through this randomized controlled trial, the investigators aim to compare two techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy. This study would provide valuable data on improved measures for predicting voiding efficiency, time to first void, and time to discharge for patients undergoing same-day total laparoscopic hysterectomies. Ultimately, the investigators predict that backfilling the bladder immediately postoperatively, prior to removal of the foley catheter, will hasten time to first spontaneous void and reduce the amount of time spent in the recovery room.
Interventions
PROCEDUREInstilIing normal saline into bladder
Backfilling the bladder with 200 mL of normal saline immediately postoperatively, prior to foley catheter removal, after same-day total laparoscopic hysterectomy can potentially increase time to first spontaneous void and time to discharge.
PROCEDURERemoval of foley catheter
Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be randomly assigned to one of two groups - A) bladder backfilled group or B) control group. This is a blinded study and the participant will not know which group they were assigned to.
Intervention model description
A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-75 years of age * Ability to comprehend English * Women undergoing same-day laparoscopic hysterectomy through the Enhanced Recovery after Surgery (ERAS) protocol at Magee-Womens Hospital (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy)
Exclusion criteria
* Women who are unable to give informed consent * History of prior or concurrent urogynecologic procedures performed including mid-urethral sling, rectocele/cystocele repairs, burch urethropexy, sacrospinous ligament fixation, uterosacral vaginal vault suspension, sacrocolpopexy * History of multiple sclerosis * Known malignancy of the bladder * Bladder or ureteral injury that occurred intra-operatively * Women who are being treated for an active urinary tract infection at the time of surgery * Women admitted overnight who fail to go home the same day after total laparoscopic hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first spontaneous void | From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks | Our primary hypothesis is that patients who undergo same-day total laparoscopic hysterectomy that are randomized into the group who have their bladders backfilled with 200 cc normal saline post-operatively, prior to removal of the foley catheter will have a shorter time to first spontaneous void. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge from the hospital after same-day laparoscopic hysterectomy | From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks | We hypothesize that patients who undergo same-day total laparoscopic hysterectomy that are randomized into the group who have their bladders filled with 200 cc normal saline post-operatively, prior to removal of the foley catheter, will have a shorter time to discharge. We will be recording the amount of time patients spend in the post-anesthesia care unit (PACU) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-operative urinary retention rates | From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks | We will also evaluate the rates of postoperative urinary retention in patients who undergo same-day total laparoscopic hysterectomy through the Enhanced Recovery After Surgery (ERAS) protocol. |
Countries
United States
Outcome results
None listed