Same-day discharge after laparoscopic hysterectomy is being practiced by an increasing number of providers.1–4 Not only is same-day discharge well tolerated, it is also associated with decreased costs.5 The “enhanced recovery after surgery” (ERAS) concept emerged as a multimodal approach directed at standardizing perioperative care, improving surgical outcomes, and enhancing the success of early discharge programs.6 Minimally invasive surgery is an integral component of ERAS and associated with improved postoperative outcomes.7 Enhanced recovery after surgery pathways call for early removal of urinary catheters after gynecologic surgery to optimize early discharge.6 Earlier removal of urinary catheters resulted in a shorter time to first void, larger volume of urine at first void, less frequent catheterization for urinary retention, and a shorter length of stay.8
Urogynecologic trials have shown that a backfill-assisted voiding trial is superior to a spontaneous voiding trial after transvaginal surgery.9,10 Studies have yet to examine the effect of a day-of-surgery voiding trial after laparoscopic hysterectomy. A successful spontaneous void is often a discharge criterion after same-day laparoscopic hysterectomy. Oftentimes, waiting for this spontaneous void can delay discharge.
We designed a single-blind, randomized, controlled trial to evaluate whether backfilling the bladder postoperatively would reduce time to discharge in patients undergoing outpatient laparoscopic hysterectomy. We hypothesized that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the postanesthesia care unit.
Approval was obtained from the Institutional Review Board of the University of Pittsburgh (PRO17010292) and the trial was registered with ClinicalTrials.gov (NCT03126162). Women 18–75 years of age undergoing outpatient laparoscopic hysterectomy through the ERAS protocol at Magee-Womens Hospital of the University of Pittsburgh Medical Center, a tertiary care institution, were approached to participate in the study. For women undergoing outpatient laparoscopic hysterectomy, the standard of care is to remove the Foley catheter at the end of the procedure. Hysterectomies included either a total laparoscopic hysterectomy or laparoscopic supracervical hysterectomy with or without bilateral salpingectomy or salpingo-oophorectomy performed by five minimally invasive gynecologic surgeons. Concurrent procedures including excision of endometriosis, ureterolysis, lysis of adhesions, enterolysis, mini-laparotomy (for specimen removal in cases with large fibroid uteri), and cystoscopy with insertion and removal of bilateral ureteral stents (used in difficult cases where retroperitoneal fibrosis is anticipated to aid in identification of ureters) were also recorded. The ERAS protocol developed at our institution for laparoscopic hysterectomies included premedication with acetaminophen, celecoxib, and perphenazine and the use of total intravenous anesthesia intraoperatively with the goal to avoid intraoperative narcotic administration. Exclusion criteria included the inability to provide informed consent, history of prior or concurrent urogynecologic procedures (mid-urethral sling, urethral bulking, anterior and posterior colporrhaphy, perineorrhaphy, Burch urethropexy, sacrospinous ligament fixation, uterosacral ligament suspension, sacrocolpopexy), history of multiple sclerosis, known malignancy of the bladder, intraoperative bladder or ureteral injury, anticipated prolonged bladder catheterization, women being treated for an active urinary tract infection at the time of surgery, or planned postoperative overnight admissions. Written informed consent was obtained. Each participant was randomly assigned to a backfill-assisted void trial (group A) or a trial of spontaneous voiding with no backfilling of the bladder (group B).
A randomization scheme using a block size of four was generated using a website (http://www.randomization.com). Sealed randomization envelopes were opened for each patient after anesthesia was initiated in the operating suite. This study was single-blinded to the participant. After group allocation, the surgeon was informed of whether the bladder will be backfilled at the completion of the surgery before Foley catheter removal. If the patient was assigned to group A, 200 mL of room temperature, sterile normal saline was instilled retrograde into the bladder at the completion of the surgery before Foley catheter removal and the Foley was subsequently removed intraoperatively. If the patient was assigned to group B, the Foley catheter was removed intraoperatively at completion of the procedure. Our standard protocol is to use a 16F Foley catheter for gynecologic laparoscopy cases and patients from both groups received the same size catheter. Two hundred milliliter of sterile saline was chosen as the amount to backfill to prevent postoperative overdistension as the patient will continue to naturally produce urine while in the recovery room awaking from anesthesia. A normal adult bladder capacity can range from 400 to 550 mL, with a normal desire to void at 300–400 mL.11
Routinely after a laparoscopic hysterectomy, patients at our institution were expected to have spontaneously voided by 6 hours. After arrival in the postanesthesia care unit, the nursing staff received standardized written orders to follow a specific voiding protocol for our study participants (Fig. 1). To evaluate for overdistension of the bladder, assessment of spontaneous void occurred at 5 hours for all participants rather than the routine 6 hours. A successful voiding trial was defined as a voided volume of at least 200 mL to be discharged home. If unable to void at least 200 mL by 5 hours after surgery, a bladder scan was performed and the volume recorded. If 200 mL or greater of urine was noted on the scan, a Foley catheter was reinserted and the patient was discharged home with the plan to return to the outpatient clinic for removal. If less than 200 mL of urine was noted on the scan, patients were given one additional hour to hydrate either orally or intravenously. If unable to spontaneously void 200 mL by 6 hours after surgery, a Foley catheter was reinserted and the patient was discharged home with the plan to return to the outpatient clinic 3 or 4 days for a retrograde voiding trial. The amount of urine voided, time of spontaneous void, and reinsertion of the Foley catheter were recorded by the nursing staff. Criteria for discharge included adequate pain control (pain score less than 5), tolerating oral intake without nausea or emesis, independent ambulation, and completion of either a spontaneous void trial or home with a Foley catheter for urinary retention. Any surgical or medical complication for which the surgeon or anesthesiologist wanted to observe the patient overnight was also a criterion for overnight admission.
Preoperative data collection included demographics, medical and surgical history, medications, and indication for hysterectomy. Intraoperative data including surgical procedure, estimated blood loss, total intravenous fluids received intraoperatively and in the postanesthesia care unit, urine output, total operative time, narcotic medications, and surgical complications were all recorded for each participant. Data pertaining to the postoperative course (eg, time of arrival in the postanesthesia care unit, time of discharge, time and volume of first spontaneous void, and voiding trial results) were documented by the nursing staff. Voiding trial results were subsequently collected by a coinvestigator and confirmed through chart review. Data on urinary retention rates, narcotics received in the postanesthesia care unit, occurrence of postoperative urinary tract infection, occurrence of postoperative voiding dysfunction, and postoperative surgical complications were collected through medical chart review by a coinvestigator for up to 8 weeks postoperatively.
Our primary aim was to determine whether backfilling the bladder in the operating room immediately before removal of the Foley catheter would reduce time to discharge in patients undergoing outpatient laparoscopic hysterectomy. We hypothesized that patients randomized to group A, who had their bladders backfilled with 200 mL of normal saline would have a shorter time to discharge compared with patients randomized to group B who just had their Foley catheters removed at the completion of surgery. We hypothesized that patients randomized to group A would have an overall shorter time to discharge. The outcome variable of interest was time spent in the postanesthesia care unit, measured in minutes from arrival time to the postanesthesia care unit to time of discharge from the hospital. Our secondary aim was to determine whether backfilling the bladder postoperatively before removal of the Foley catheter reduced time to spontaneous void. Our outcome variable of interest was time to first spontaneous void, measured in minutes from the end of surgery. In addition, we aimed to determine whether covariates, such as narcotic usage and total intravenous fluids received, influenced time to spontaneous voiding. Other important secondary outcomes included group comparisons for rates of urinary retention, postoperative complications, readmissions, emergency department visits, and urinary tract infections.
An a priori power analysis was undertaken to determine an adequate sample size for our primary outcome, time to discharge. We estimated that 152 patients (76/group) would provide greater than 80% power to identify a 30-minute difference in the primary outcome (time to discharge assessed by length of time spent in postanesthesia care unit) from baseline length of time spent in the postanesthesia care unit of 227 minutes (based on prior study data) with an SD of 56 minutes and a two-sided significance level of 0.05.9
All statistical analyses were performed using SAS 9. Data are presented as means (±SD) for continuous variables or medians (interquartile range) for data not normally distributed. Categorical data are presented as frequency (percentage). Group means that follow normal distributions were compared using Student's t tests. Nonnormal distributions were compared using Wilcoxon rank-sum tests. Chi-squared analyses or Fisher's exact tests were used to compare proportional data. Multivariable modeling was done using logistic regression. All outcomes were evaluated at a 0.05 level of significance. Individual participant data (including data dictionaries) will not be available or shared.
Authors' Data Sharing Statement
- Will individual participant data be available (including data dictionaries)? No.
- What data in particular will be shared? Not available.
- What other documents will be available? Not available.
- When will data be available (start and end dates)? Not applicable.
- By what access criteria will data be shared (including with whom, for what types of analyses, and by what mechanism)? Not applicable.
Recruitment occurred from June 2017 to May 2018 at Magee-Womens Hospital of the University of Pittsburgh Medical Center. Of the 202 women screened for eligibility, 172 consented for enrollment, and 162 patients were randomized. Eighty-one patients were allocated to group A, the backfill-assisted voiding group and 81 to group B, the spontaneous voiding group. Six patients from group A and three patients from group B were admitted overnight and therefore excluded in our analysis, resulting in 75 patients in group A and 78 patients in group B (Fig. 2).
Baseline characteristics were similar between the two groups (Table 1). There was no difference in baseline demographics, prior surgical history, or indication for hysterectomy between the two groups. The most common indications for hysterectomy were symptomatic uterine fibroids (38.7%, 37.2%) and pelvic pain (37.3%, 41%) for groups A and B, respectively. The most common type of hysterectomy performed was a total laparoscopic hysterectomy (98.7%) (Table 1). There were also no differences in concomitant procedures performed at the time of laparoscopic hysterectomy between the two groups as well as intraoperative factors including length of surgery (time of incision to skin closure), total intravenous fluids given intraoperatively, urine output, or estimated blood loss. Postoperatively in the postanesthesia care unit, there was no difference between the two groups with the length of time spent in the postanesthesia care unit or amount of intravenous fluids given. Both groups received a similar amount of narcotics preoperatively, intraoperatively, and postoperatively (Table 2).
For the primary outcome, time to discharge was assessed by the length of time spent in the postanesthesia care unit. The mean time to discharge was 273.4 minutes for group A compared with 283.2 minutes for group B, a difference of 9.8 minutes which was not found to be significant (P=.45) (Table 3). The mean time to first spontaneous void was 181.1 minutes in group A compared with 206.0 minutes in group B (Table 3). There was a significant reduction of 24.9 minutes in time to first spontaneous void with patients randomized to the backfill group (P=.04). The total amount of intravenous fluids received was not associated with time to spontaneous void (P=.26). The total amount of narcotics received also did not influence time to first spontaneous void (P=.31). However, when the total amount of narcotics received was calculated before spontaneous void, more narcotics taken prevoid slowed down time to void, which was found to be significant (P=.03). Bladder filling before removing the Foley catheter was not associated with increased rates of postoperative urinary retention. Five patients (6.7%) in group A and 10 patients (12.8%) in group B developed urinary retention postoperatively and required recatheterization before discharge, which was also not significant (P=.20).
For additional secondary outcomes, the number of emergency department visits, rates of urinary tract infections, and readmissions were similar between the two groups (Table 3). Emergency department visits were assessed up until 8 weeks postoperatively and were similar between groups A and B (5.3% vs 6.4%, P=.78). Similarly, rates of urinary tract infections were low and not different between groups A and B (1.3% vs 3.8%, P=.33). The number of readmissions was also similar (Table 3). In group A, one patient was admitted on postoperative day 3 for workup of a fever and another was admitted for inpatient management of incisional cellulitis on postoperative day 7. In group B, there was one patient admitted on postoperative day 9 for management of a pelvic abscess and another patient who was admitted on postoperative day 1 with a large pelvic hematoma due to a mechanical fall unrelated to surgery. None of the postoperative complications were directly related to the study intervention. Although our findings revealed similarities between the two groups in rates of emergency department visits, urinary tract infections, and readmissions, these counts of adverse outcomes are low and therefore underpowered to generalize that there is no true difference.
This study demonstrates that a backfill-assisted void trial with 200 mL of normal saline instilled into the bladder before Foley catheter removal decreases time to first spontaneous void but does not significantly affect time to discharge in patients undergoing outpatient laparoscopic hysterectomy. Backfilling the bladder before a voiding trial is feasible compared with a standard spontaneous voiding trial.12 This technique is commonly implemented to test for voiding dysfunction after urogynecologic and urologic surgery; however, it is not routinely performed after other gynecologic procedures.10 We are not aware of any previous studies specifically assessing time to discharge after postoperative bladder testing in outpatient laparoscopic hysterectomy patients.
Although ERAS pathways have been shown to reduce length of stay in abdominal gynecologic surgery with early removal of urinary catheters, studies have not assessed length of stay for outpatient gynecologic procedures.13 As many hospital systems are moving towards expedited recovery to decrease costs and complications associated with hospitalization, optimizing postoperative care and length of stay may lead to reduced hospital costs and decreased burden to nursing staff and other providers.10,14–16 Previous voiding studies in urogynecologic and urologic literature have reported mixed results with regards to time of discharge. Foster et al9 found that patients randomized to a backfill group after outpatient transvaginal surgery (eg, midurethral sling, perineorrhaphy, rectocele, cystocele repair or both) were more likely to adequately empty their bladder and had a shorter mean stay of 27.1 minutes in the postanesthesia care unit. Boccola et al showed that bladder filling before a trial of void in patients undergoing prostate surgery reduced time to discharge by 112.5 minutes.17 Du et al12 showed that bladder filling before a trial of void for patients posttransurethral resection of prostate, bladder neck incision, or admitted with urinary retention showed a reduction in time to discharge of 39.5 minutes. We used a reduction in time to discharge of 30 minutes based on prior study data to calculate our sample size at a power of 0.8.9 Bladder filling before Foley catheter removal did not reduce time to discharge in our study population owing to several possibilities. Factors such as nausea, postoperative pain, or social issues (eg, transportation) could have contributed to a delay in discharge. Another possibility could be nursing staff not adequately accustomed to same-day discharge after laparoscopic hysterectomy. Because patients have traditionally stayed overnight, nurses may still be in that mindset and not comfortable with the newly implemented compressed timeline. This may result in reluctance to discharging patients in a shorter amount of time, even if patients have met their discharge milestones. Thus, a reduction of 24.9 minutes in time to spontaneous void in the backfill group may not have resulted in a reduced time to discharge.
Other limitations of this study include the lack of racial diversity. This study had predominantly Caucasian or African American participants and an underrepresentation of other races besides Asian when compared with the national population. This may be representative of local demographics and the fact that the study was carried out at a single institution, limiting the generalizability of our results. Another limitation was not collecting outcome measures related to voiding dysfunction in the first 4 weeks after surgery. Voiding dysfunction is infrequently seen after routine gynecologic procedures compared with urogynecologic procedures, especially after a successful spontaneous voiding trial. However, short-term abnormalities in bladder sensation are influenced by postsurgical factors such as pain, edema, inflammation, and anesthesia; thus a formal assessment with a validated questionnaire assessing patient satisfaction could have contributed to the results of this study.18,19
Major strengths of this study include the study design allowing a direct comparison of two commonly used techniques for assessing postoperative voiding. Furthermore, our enrollment acceptance rate of 85% and drop-out incidence of 5.5% reduces the concern for selection bias. Lastly, the nursing staff who carried out the study protocol were blinded to the intervention assignment (backfill-assisted vs spontaneous voiding) during data collection for our primary and secondary outcomes, limiting observer bias.
We conclude that bladder filling before removing the Foley catheter is a safe and simple alternative to a spontaneous voiding trial that can reduce time to first spontaneous void in patients undergoing outpatient laparoscopic hysterectomy. Despite being feasible with no additional morbidity, it has not been shown to significantly reduce time to discharge.
1. Gien LT, Kupets R, Covens A. Feasibility of same-day discharge after laparoscopic surgery in gynecologic oncology. Gynecol Oncol 2011;121:339–43.
2. Hoffman CP, Kennedy J, Borschel L, Burchette R, Kidd A. Laparoscopic hysterectomy: the Kaiser Permanente San Diego experience. J Minim Invasive Gynecol 2005;12:16–24.
3. Perron-Burdick M, Yamamoto M, Zaritsky E. Same-day discharge after laparoscopic hysterectomy. Obstet Gynecol 2011;117:1136–41.
4. Taylor RH. Outpatient laparoscopic hysterectomy with discharge in 4 to 6 hours. J Am Assoc Gynecol Laparosc 1994;1:S35.
5. Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, et al. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol 2012;207:382.e1–9.
6. Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, et al. Enhanced recovery implementation in major gynecologic surgeries: effect of care standardization. Obstet Gynecol 2016;128:457–66.
7. Abeles A, Kwasnicki RM, Darzi A. Enhanced recovery after surgery: current research insights and future direction. World J Gastrointest Surg 2017;9:37–45.
8. Ind TEJ, Brown R, Pyneeandee VM, Swanne M, Taylor G. Midnight removal of urinary catheters - improved outcome after gynecological surgery. Int Urogynecol J 1993;4:342–5.
9. Foster RT, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol 2007;197:627.e1–4.
10. Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol 2011;118:637–42.
11. Lukacz ES, Sampselle C, Gray M, Macdiarmid S, Rosenberg M, Ellsworth P, et al. A healthy bladder: a consensus statement. Int J Clin Pract 2011;65:1026–36.
12. Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg 2013;83:239–42.
13. de Groot JJ, Ament SM, Maessen JM, Dejong CH, Kleijnen JM, Slangen BF. Enhanced recovery pathways in abdominal gynecologic surgery: a systematic review and meta-analysis. Acta Obstet Gynecol Scand 2016;95:382–95.
14. Barber EL, Neubauer NL, Gossett DR. Risk of venous thromboembolism in abdominal versus minimally invasive hysterectomy for benign conditions. Am J Obstet Gynecol 2015;212:609.e1–7.
15. Graves N, Janda M, Merollini K, Gebski V, Obermair A. The cost-effectiveness of total laparoscopic hysterectomy compared to total abdominal hysterectomy for the treatment of early stage endometrial cancer. BMJ Open 2013;3:e001884.
16. Mahdi H, Goodrich S, Lockhart D, DeBernardo R, Moslemi-Kebria M. Predictors of surgical site infection in women undergoing hysterectomy for benign gynecologic disease: a multicenter analysis using the National surgical quality improvement program data. J Minim Invasive Gynecol 2014;21:901–9.
17. Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int 2011;107(suppl 3):43–6.
18. Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology 2009;110:1139–57.
19. Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health 2014;6:829–38.