Metronidazole and cefazolin vs cefazolin alone for surgical site infection prophylaxis in gynecologic surgery at a comprehensive cancer center.

BACKGROUND: Surgical site infection is one of the most common complications of gynecologic cancer surgery. Current guidelines recommend the administration of cefazolin preoperatively to reduce surgical site infection rates for patients undergoing clean-contaminated surgeries such as hysterectomy. OBJECTIVE: To evaluate the impact of a quality improvement project adding metronidazole to cefazolin for antibiotic prophylaxis on surgical site infection rate for women undergoing gynecologic surgery at a comprehensive cancer center. STUDY DESIGN: This retrospective, single-center cohort study included patients who underwent surgery in the gynecologic oncology department from May 2017 to June 2023. Patients with penicillin allergies and those undergoing concomitant bowel resections and/or joint cases were excluded. The preintervention group patients had surgery from May 2017 to April 2022, and the postintervention group patients had surgery from April 2022 to June 2023. The primary outcome was a 30-day surgical site infection rate. Sensitivity analyses were performed to compare surgical site infection rates on the basis of actual antibiotics received and for those who had a hysterectomy. Factors independently associated with surgical site infection were identified using a multivariable logistic regression model adjusting for confounding variables. RESULTS: Of 3343 patients, 2572 (76.9%) and 771 (23.1%) were in the pre-post intervention groups, respectively. Most patients (74.7%) had a hysterectomy performed. Thirty-four percent of cases were for nononcologic (benign) indications. Preintervention patients were more likely to receive appropriate preoperative antibiotics (95.6% vs 90.7%; P<.001). The overall surgical site infection rate before the intervention was 4.7% compared with 2.6% after (P=.010). The surgical site infection rate for all patients who underwent hysterectomy was 4.9% (preintervention) vs 2.8% (postintervention) (P=.036); a similar trend was seen for benign cases (4.4% vs 2.4%; P=.159). On multivariable analysis, the odds ratio for surgical site infection was 0.49 (95% confidence interval, 0.38-0.63) for the postintervention compared with the preintervention group (P<.001). In a sensitivity analysis (n=3087), the surgical site infection rate was 4.5% for those who received cefazolin alone compared with 2.3% for those who received cefazolin plus metronidazole, with significantly decreased odds of surgical site infection for the cefazolin plus metronidazole group (adjusted odds ratio, 0.40 [95% confidence interval, 0.30-0.53]; P<.001). Among only those who had a hysterectomy performed, the odds of surgical site infection were significantly reduced for those in the postintervention group (adjusted odds ratio, 0.63 [95% confidence interval, 0.47-0.86]; P=.003). CONCLUSION: The addition of metronidazole to cefazolin before gynecologic surgery decreased the surgical site infection rate by half, even after accounting for other known predictors of surgical site infection and differences in practice patterns over time. Providers should consider this combination regimen in women undergoing gynecologic surgery, especially for cases involving hysterectomy.

Detection and Management of Perioperative Hyperglycemia at a Tertiary Cancer Center.

INTRODUCTION: To improve the detection and management of perioperative hyperglycemia at our tertiary cancer center, we implemented a glycemic control quality improvement initiative. The primary goal was to decrease the percentage of diabetic patients with median postoperative glucose levels > 180 mg/dL during hospitalization by 15% within 2 years. METHODS: A multidisciplinary team standardized preoperative screening, preoperative, intraoperative, and postoperative hyperglycemia management. We included all patients undergoing nonemergent inpatient and outpatient operations. We used a t test, rank sum, chi-square, or Fisher's exact test to assess differences in outcomes between patients at baseline (BL) (10/2018-4/2019), during the first phase (P1) (10/2019-4/2020), second phase (P2) (5/2020-12/2020), and maintenance phase (M) (1/2021-10/2022). RESULTS: The analysis included 9891 BL surgical patients (1470 with diabetes), 8815 P1 patients (1233 with diabetes), 10,401 P2 patients (1531 with diabetes) and 30,410 M patients (4265 with diabetes). The percentage of diabetic patients with median glucose levels >180 mg/dL during hospitalization decreased 32% during the initiative (BL, 20.1%; P1, 16.9%; P2, 12.1%; M, 13.7% [P < .001]). We also saw reductions in the percentages of diabetic patients with median glucose levels >180 mg/dL intraoperatively (BL, 34.0%; P1, 26.6%; P2, 23.9%; M, 20.3% [P < .001]) and in the postanesthesia care unit (BL, 36.0%; P1, 30.4%; P2, 28.5%; M, 25.8% [P < .001]). The percentage of patients screened for diabetes by hemoglobin A1C increased during the initiative (BL, 17.5%; P1, 52.5%; P2, 66.8%; M 74.5% [P < .001]). CONCLUSIONS: Our successful initiative can be replicated in other hospitals to standardize and improve glycemic control among diabetic surgical patients.

Efficacy, safety, and feasibility of Apixaban for postoperative venous thromboembolism prophylaxis following open gynecologic cancer surgery at a comprehensive cancer center.

OBJECTIVES: To evaluate safety, efficacy, and feasibility of apixaban for postoperative venous thromboembolism (VTE) prophylaxis following open gynecologic cancer surgery at a comprehensive cancer center. METHODS: This retrospective, cohort study included patients with gynecologic cancer who underwent open surgery between 3/2021 and 3/2023 and received 28-day postoperative VTE prophylaxis. Patients on therapeutic anticoagulation preoperatively were excluded. Predictors of 90- and 30-day VTE and 30-day bleeding events were determined using multivariable logistic regression, adjusting for known confounders. RESULTS: 452 patients were included in the cohort: 348 received apixaban and 104 received enoxaparin. Those who received enoxaparin were more likely to be American Society of Anesthesiologists class III/IV (compared to I/II) (p = 0.033), current or former smokers (p = 0.012) and have a higher BMI (p < 0.001), Charlson Comorbidity Index (p = 0.005), and age (p = 0.046). 30-day VTE rate was significantly lower in the apixaban group (0.6%) compared to the enoxaparin group (6.2%) (adjusted OR 0.13, 95% CI 0.03-0.56; p = 0.006). 90-day VTE rate was 2.7% and 6.2% in the apixaban and enoxaparin groups, respectively (adjusted OR 0.85, 95% CI 0.38-1.92; p = 0.704). Major bleeding complications (2.4% vs. 2.0%) and minor bleeding complications (0.9% vs. 3.0%) were similar in the apixaban and enoxaparin groups, respectively, on multivariate analyses. The median patient out of pocket cost was $10 (IQR 0.0-40.0) for apixaban and $20 (IQR 3.7-67.7) for enoxaparin (p = 0.001). CONCLUSIONS: Our findings along with previously published data suggest that apixaban should be considered the standard of care for VTE prophylaxis in patients undergoing open surgery for gynecologic malignancies.

Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy.

BACKGROUND: There are few prospective studies in the gynecologic surgical literature that compared patient-reported outcomes between open and minimally invasive hysterectomies within enhanced recovery after surgery pathways. OBJECTIVE: This study aimed to compare prospectively collected perioperative patient-reported symptom burden and interference measures in open compared with minimally invasive hysterectomy cohorts within enhanced recovery after surgery pathways. STUDY DESIGN: We compared patient-reported symptom burden and functional interference in 646 patients who underwent a hysterectomy (254 underwent open surgery and 392 underwent minimally invasive surgery) for benign and malignant indications under enhanced recovery after surgery protocols. Outcomes were prospectively measured using the validated MD Anderson Symptom Inventory, which was administered perioperatively up to 8 weeks after surgery. Cohorts were compared using Fisher exact and chi-squared tests, adjusted longitudinal generalized linear mixed modeling, and Kaplan Meier curves to model return to no or mild symptoms. RESULTS: The open cohort had significantly worse preoperative physical functional interference (P=.001). At the time of hospital discharge postoperatively, the open cohort reported significantly higher mean symptom severity scores and more moderate or severe scores for overall (P<.001) and abdominal pain (P<.001), fatigue (P=.001), lack of appetite (P<.001), bloating (P=.041), and constipation (P<.001) when compared with the minimally invasive cohort. The open cohort also had significantly higher interference in physical functioning (score 5.0 vs 2.7; P<.001) than the minimally invasive cohort at the time of discharge with no differences in affective interference between the 2 groups. In mixed modeling analysis of the first 7 postoperative days, both cohorts reported improved symptom burden and functional interference over time with generally slower recovery in the open cohort. From 1 to 8 postoperative weeks, the open cohort had worse mean scores for all evaluated symptoms and interference measures except for pain with urination, although scores indicated mild symptomatic burden and interference in both cohorts. The time to return to no or mild symptoms was significantly longer in the open cohort for overall pain (14 vs 4 days; P<.001), fatigue (8 vs 4 days; P<.001), disturbed sleep (2 vs 2 days; P<.001), and appetite (1.5 vs 1 days; P<.001) but was significantly longer in the minimally invasive cohort for abdominal pain (42 vs 28 days; P<.001) and bloating (42 vs 8 days; P<.001). The median time to return to no or mild functional interference was longer in the open than in the minimally invasive hysterectomy cohort for physical functioning (36 vs 32 days; P<.001) with no difference in compositive affective functioning (5 vs 5 days; P=.07) between the groups. CONCLUSION: Open hysterectomy was associated with increased symptom burden in the immediate postoperative period and longer time to return to no or mild symptom burden and interference with physical functioning. However, all patient-reported measures improved within days to weeks of both open and minimally invasive surgery and differences were not always clinically significant.

Evaluation of a tiered opioid prescription algorithm in an ERAS pathway: exploring opportunities for further refinement.

BACKGROUND: Opioid over-prescription is wasteful and contributes to the opioid crisis. We implemented a personalized tiered discharge opioid protocol and education on opioid disposal to minimize over-prescription. OBJECTIVE: To evaluate the intervention by investigating opioid use post-discharge for women undergoing abdomino-pelvic surgery, and patient adherence to opioid disposal education. METHODS: We analyzed post-discharge opioid consumption among 558 patients. Eligible patients included those who underwent elective gynecologic surgery, were not taking scheduled opioids pre-operatively, and received discharge opioids according to a tiered prescribing algorithm. A survey assessing discharge opioid consumption and disposal safety knowledge was distributed on post-discharge day 21. Over-prescription was defined as >20% of the original prescription left over. Descriptive statistics were used for analysis. RESULTS: The survey response rate was 61% and 59% in the minimally invasive surgery and open surgery cohorts, respectively. Overall, 42.8% of patients reported using no opioids after hospital discharge, 45.2% in the minimally invasive surgery and 38.6% in the open surgery cohort. Furthermore, 74.9% of respondents were over-prescribed, with median age being statistically significant for this group (p=0.004). Finally, 46.4% of respondents expressed no knowledge regarding safe disposal practices, with no statistically significant difference between groups (p>0.99). CONCLUSION: Despite implementation of the tiered discharge opioid algorithm aimed to personalize opioid prescriptions to estimated need, we still over-prescribed opioids. Additionally, despite targeted education, nearly half of all patients who completed the survey did not know how to dispose of their opioid tablets. Additional efforts are needed to further refine the algorithm to reduce over-prescription of opioids and improve disposal education.

Sentinel lymph node mapping with indocyanine green using SPY-PHI in open radical hysterectomy or trachelectomy.

OBJECTIVE: To evaluate the detection rate of at least one sentinel lymph node (SLN) in patients with early cervical cancer who underwent open radical hysterectomy or trachelectomy using indocyanine green (ICG) with the SPY Portable Handler Imager (SPY-PHI) system. METHODS: We retrospectively reviewed patients with cervical cancer FIGO 2018 stage IA1 with lymphovascular invasion up to stage IIIC1p who underwent SLN mapping and open radical hysterectomy or trachelectomy from March 2018 through August 2022 at The University of Texas MD Anderson Cancer Center. ICG was the only tracer used with the SPY-PHI system. Patient demographics, surgical approach, and tumor factors were analyzed. Overall detection, bilateral detection, and empty lymph node packet rates were determined. RESULTS: A total of 106 patients were included. Ninety-four (88.7%) patients underwent open radical hysterectomy and 12 (11.3%) open radical trachelectomy. Median age was 40 years (range, 23-71). Median body mass index was 28.8 kg/m2 (range, 17.6-48.4). The most common FIGO 2018 stages were IB1 (35%) and IB2 (30%). The most common histologic subtypes were squamous cell carcinoma (45%) and adenocarcinoma (45%). Most patients had grade 2 disease (61%) and no lymphovascular invasion (58%). Median tumor size was 1.8 cm (range, 0.3-4). Median number of detected SLN was 4 (range, 0-12). An SLN was identified during surgery in 104 patients (98%), with bilateral mapping in 94 (89%) and unilateral mapping in 10 (9%). The empty lymph node packet rate was 4 (3.8%). The external iliac (73%) was the most common site of SLN detection. Fourteen patients had positive lymph nodes (13.5%); 3 (21.4%) had macrometastases, 9 (64.3%) had micrometastases, and 2 (14.3%) had isolated tumor cells. CONCLUSION: SLN mapping using ICG with the SPY-PHI system in open radical hysterectomy or trachelectomy is reliable and results in high overall and bilateral detection rates in patients with early cervical cancer.

Rate of venous thromboembolism on an enhanced recovery program after gynecologic surgery.

BACKGROUND: Venous thromboembolism is a life-threatening complication of surgery. An Enhanced Recovery After Surgery program is a multimodal care pathway that facilitates faster recovery from surgery. The rate of venous thromboembolism after gynecologic surgery on an Enhanced Recovery After Surgery program is unknown. OBJECTIVE: This study aimed to evaluate the rate of venous thromboembolism within 30 days of gynecologic surgery on an Enhanced Recovery After Surgery pathway performed at a cancer center. STUDY DESIGN: Data were collected prospectively on Enhanced Recovery After Surgery pathway gynecologic patients undergoing open surgery (November 3, 2014, to March 31, 2021) and minimally invasive surgery (February 1, 2017, to March 31, 2021). Care was delivered at a tertiary cancer care center located in a large urban area. Patients undergoing emergency surgery or multispecialty surgeries were excluded. Patients undergoing open surgery were to receive heparin prophylaxis before surgery, sequential compression devices during surgery and admission, and low-molecular-weight heparin prophylaxis during admission. If diagnosed with malignancy, patients were to receive extended venous thromboembolism prophylaxis for 28 days after surgery. For minimally invasive surgery, patients received only sequential compression devices during surgery and no heparin prophylaxis before or after surgery. Venous thromboembolism events were included if detected on imaging obtained for symptoms or other indications. Descriptive statistics and bivariate statistical analyses were performed. RESULTS: Of 3329 patients, 1519 (45.6%) underwent laparotomy, 1452 (43.6%) underwent laparoscopy, and 358 (10.8%) underwent robotic surgery. The incidence rates of venous thromboembolism were 0.6% (n=21; 95% confidence interval, 0.4%-0.9%) overall, 1.1% (n=16, 95% confidence interval, 0.6%-1.7%) in the open approach, and 0.3% (n=5; 95% confidence interval, 0.3%-0.6%) in the minimally invasive approach (P=.02). The incidence rates of venous thromboembolism among the 1999 patients with malignancy were 0.9% (n=18; 95% confidence interval, 0.5%-1.4%) overall, 1.4% (n=15; 95% confidence interval, 0.7%-2.2%) in the open approach, and 0.3% (n=3; 95% confidence interval, 0.1%-0.9%) in the minimally invasive approach. The incidence rates of venous thromboembolism among the 1165 patients with benign disease were 0.3% (n=3; 95% confidence interval, 0.1%-0.7%) overall, 0.3% (n=1; 95% confidence interval, 0.0%-1.7%) in the open approach, and 0.2% (n=2; 95% confidence interval, 0.0%-0.9%) in the minimally invasive approach. CONCLUSION: The rate of venous thromboembolism among patients undergoing laparotomy and minimally invasive surgery on an Enhanced Recovery After Surgery pathway was ≤1%. This study established a benchmark for the rate of venous thromboembolism after gynecologic surgery on an Enhanced Recovery After Surgery pathway performed at a cancer center.

Patient-reported symptoms at discharge and risk of complications after gynecologic surgery.

OBJECTIVE: Current gaps in knowledge limit clinicians from fully implementing patient-reported outcomes in routine post-operative care. METHODS: This prospective study assessed symptoms via the gynecologic module of the MD Anderson Symptom Inventory (MDASI-PeriOp-GYN) in patients who underwent open laparotomy. RESULTS: At discharge, patient-reported moderate to severe (≥4 on a 0-10 scale) abdominal bloating or abdominal cramping, combined with length of stay of ≥4 days, were found to be associated with a higher risk of 30-day post-operative grade II-IV complications by the Clavien-Dindo system (all p values <0.01). Also, length of stay of ≥4 days and moderate to severe urinary urgency at discharge were found to be associated with the need for re-admission (all p values <0.01). CONCLUSION: This study defined the clinically meaningful symptoms that related to the risk of developing important complications after discharge from major open gynecological surgery.These findings support the integration of assessment of patient-reported outcomes into patient-centered post-operative care.

Development and implementation of an institutional enhanced recovery program data process.

Background: With increasing implementation of enhanced recovery programs (ERPs) in clinical practice, standardised data collection and reporting have become critical in addressing the heterogeneity of metrics used for reporting outcomes. Opportunities exist to leverage electronic health record (EHR) systems to collect, analyse, and disseminate ERP data. Objectives: (i) To consolidate relevant ERP variables into a singular data universe; (ii) To create an accessible and intuitive query tool for rapid data retrieval. Method: We reviewed nine established individual team databases to identify common variables to create one standard ERP data dictionary. To address data automation, we used a third-party business intelligence tool to map identified variables within the EHR system, consolidating variables into a single ERP universe. To determine efficacy, we compared times for four experienced research coordinators to use manual, five-universe, and ERP Universe processes to retrieve ERP data for 10 randomly selected surgery patients. Results: The total times to process data variables for all 10 patients for the manual, five universe, and ERP Universe processes were 510, 111, and 76 min, respectively. Shifting from the five-universe or manual process to the ERP Universe resulted in decreases in time of 32% and 85%, respectively. Conclusion: The ERP Universe improves time spent collecting, analysing, and reporting ERP elements without increasing operational costs or interrupting workflow. Implications: Manual data abstraction places significant burden on resources. The creation of a singular instrument dedicated to ERP data abstraction greatly increases the efficiency in which clinicians and supporting staff can query adherence to an ERP protocol.

Patient outcomes and adherence to an enhanced recovery pathway for open gynecologic surgery: a 6-year single-center experience.

OBJECTIVES: To evaluate compliance with an Enhanced Recovery After Surgery (ERAS) protocol for open gynecologic surgery at a tertiary center and the relationship between levels of compliance and peri-operative outcomes. METHODS: This retrospective cohort study was conducted between November 2014 and December 2020. Two groups were defined based on compliance level (<80% vs ≥80%). The primary outcome was to analyze overall compliance since implementation of the ERAS protocol. The secondary endpoint was to assess the relationship between compliance and 30-day re-admission, length of stay, re-operation, opioid-free rates, and post-operative complications. We also assessed compliance with each ERAS element over three time periods (P1: 2014-2016, P2: 2017-2018, P3: 2019-2020), categorizing patients according to the date of surgery. Values were compared between P1 and P3. RESULTS: A total of 1879 patients were included. Overall compliance over the period of 6 years was 74% (95% CI 71.9% to 78.2%). Mean overall compliance increased from 69.7% to 75.8% between P1 and P3. Compliance with ERAS ≥80% was associated with lower Clavien-Dindo complication rates (grades III (OR 0.55; 95% CI 0.33 to 0.93) and V (OR 0.08, 95% CI 0.01 to 0.60)), 30-day re-admission rates (OR 0.61; 95% CI 0.43 to 0.88), and length of stay (OR 0.59; 95% CI 0.47 to 0.75). No difference in opioid consumption was seen. Pre-operatively, there was increased adherence to counseling by 50% (p=0.01), optimization by 21% (p=0.02), and carbohydrate loading by 74% (p=0.02). Intra-operatively, compliance with use of short-acting anesthetics increased by 37% (p=0.01) and avoidance of abdominal drainage increased by 7% (p=0.04). Use of goal-directed fluid therapy decreased by 16% (p=0.04). Post-operatively, there was increased compliance with avoiding salt and water overload (8%, p=0.02) and multimodal analgesia (5%, p=0.02). CONCLUSIONS: Over the time period of the study, overall compliance increased from 69.7% to 75.8%. Compliance (≥80%) with ERAS is associated with lower complication rates, fewer 30-day re-admissions, and shorter length of stay without impacting re-operation rates and post-operative opioid use.

Impact of timing of urinary catheter removal on voiding dysfunction after radical hysterectomy for early cervical cancer.

OBJECTIVES: To evaluate whether the timing of postoperative urinary catheter removal is associated with voiding dysfunction after radical hysterectomy for early cervical cancer within contemporary surgical practice. METHODS: We performed an institutional retrospective cohort study of patients who underwent Piver type II-III open or minimally invasive radical hysterectomy for early-stage cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA1 with lymphovascular invasion to stage IIA) between January 2006 and December 2019. We compared voiding dysfunction (inability to spontaneously void with a post-void residual <100 mL after catheter removal) and outcomes based on postoperative timing of urinary catheter removal using univariate and multivariate logistic regressions. RESULTS: Among 234 patients, 86 (36.8%) underwent open surgery and 112 (47.9%) used enhanced recovery after surgery (ERAS) pathways. 29 (12.4%) patients had urinary catheter removal between 1-5 days postoperatively (group 1), 141 (60.3%) between 6-10 days (group 2), and 64 (27.3%) between 11-15 days (group 3). The overall rate of voiding dysfunction was 11.5%, with no difference between group 1 (17.2%), group 2 (11.3%), and group 3 (9.4%) (p=0.54). Group 1 had a significantly shorter time from surgery to spontaneous voiding (4 days, IQR 3-5 days) compared with group 2 (8 days, IQR 7-10 days) and group 3 (13 days, IQR 11-15 days) (p<0.01). There was no difference in hospital length of stay, urinary tract infection, or re-admission due to a genitourinary complication within 60 days of surgery based on timing of catheter removal. On multivariate analysis, the odds of voiding dysfunction did not differ by tumor size, type of hysterectomy, cancer stage, surgical approach, ERAS timeframe, or timing of catheter removal group. CONCLUSION: There was no difference in voiding dysfunction or postoperative genitourinary complications based on timing of urinary catheter removal after radical hysterectomy. Early catheter removal should be considered in this population.

Outcomes of open radical hysterectomy following implementation of an enhanced recovery after surgery program.

OBJECTIVE: Open surgery has become the standard approach for radical hysterectomy in early stage cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2018 IA1 with lymphovascular space invasion-IIA1). Our primary objective was to compare the length of stay in patients undergoing open radical hysterectomy before and after implementation of an enhanced recovery after surgery (ERAS) program. METHODS: This was a single center, retrospective, before-and-after intervention study including patients who underwent open radical hysterectomy for cervical cancer from January 2009 to December 2020. Two groups were identified based on the time of ERAS implementation: pre-ERAS group included patients who were operated on between January 2009 and October 2014; post-ERAS group included patients who underwent surgery between November 2014 and December 2020. RESULTS: A total of 81 patients were included, of whom 29 patients were in the pre-ERAS group and 52 patients in the post-ERAS group. Both groups had similar clinical characteristics with no differences in terms of median age (42 years (interquartile range (IQR) 35-53) in pre-ERAS group vs 41 years (IQR 35-49) in post-ERAS group; p=0.47) and body mass index (26.1 kg/m2 (IQR 24.6-29.7) in pre-ERAS group vs 27.1 kg/m2 (IQR 23.5-33.5) in post-ERAS group; p=0.44). Patients in the post-ERAS group were discharged from the hospital earlier compared with those in the pre-ERAS group (median 3 days (IQR 2-3) vs 4 (IQR 3-4), p<0.01). The proportion of patients discharged within 48 hours was significantly higher in the post-ERAS group (47.3% vs 17.3%, p=0.013). There were no differences regarding either overall complications (44.8% pre-ERAS vs 38.5% post-ERAS; p=0.57) or readmission rates within 30 days (20.7% pre-ERAS group vs 17.3% ERAS group; p=0.40). Adherence to the ERAS pathway since its implementation in 2014 has remained stable with a median of 70% (IQR 65%-75%). CONCLUSIONS: Patients undergoing open radical hysterectomy on an ERAS pathway have a shorter length of hospital stay without increasing overall complications or readmissions rates.

Incidence of acute kidney injury after open gynecologic surgery in an enhanced recovery after surgery pathway.

OBJECTIVE: To determine the incidence of postoperative AKI after open gynecologic surgery within ERAS, compare AKI in pre-ERAS and ERAS cohorts, and identify factors associated with AKI. METHODS: We compared postoperative AKI in patients who underwent open gynecologic surgery at one institution before and after ERAS implementation. AKI was defined as acute risk, injury, or failure by RIFLE criteria. Pre-ERAS and ERAS cohorts were matched using propensity score analysis in a 1:1 fashion using the nearest neighbor technique. Chi-squared, Fisher's Exact, and Wilcoxon rank-sum tests were used. RESULTS: Among 1334 ERAS and 191 pre-ERAS patients, postoperative AKI incidence was higher in the ERAS cohort (13.1% vs 5.8%, p = .004). In 166 matched pairs, ERAS patients had higher incidence (16.9% vs 5.4%, p < .001) and odds (OR 3.54, 95% CI 1.61-7.76) of AKI. Within ERAS, AKI was associated with older age (median age 65 vs 57, p < .001), Charlson Comorbidity Index score ≥ 3 (71.4% vs 57.9%, p < .001), and higher intraoperative estimated blood loss (400 vs 225 mL, p < .001), fluid administration (net fluid balance +1535 vs 1261 mL, p < .001), and hypotension lasting >5 min (41.7% vs 30.7%, p < .001). ERAS patients with AKI had longer hospital stays (median 4 vs 3 days, p < .001) and more readmissions (19% vs. 10%, p < .001) and grade 3+ complications (26% vs. 7%, p < .001). CONCLUSIONS: The incidence and odds of postoperative AKI was higher after gynecologic surgery within ERAS, and patients with AKI were more likely to have complications. Potential strategies to prevent postoperative AKI include perioperative fluid and blood pressure optimization.

Impact of a tiered discharge opioid algorithm on prescriptions and patient-reported outcomes after open gynecologic surgery.

OBJECTIVE: To compare discharge opioid refills, prescribed morphine equivalent dose and quantity, and longitudinal patient-reported outcomes before and after implementation of a tiered opioid prescribing algorithm among women undergoing open gynecologic surgery within an enhanced recovery after surgery program. METHODS: We compared opioid prescriptions, clinical outcomes, and patient-reported outcomes among 273 women. Post-discharge symptom burden was collected up to 42 days after discharge using the validated 27-item MD Anderson Symptom Inventory and analyzed using linear mixed effects models and Kaplan-Meier curves for symptom recovery. RESULTS: Among 113 pre-implementation and 160 post-implementation patients there was no difference in opioid refills (9.7% vs 11.3%, p=0.84). The post-implementation cohort had a significant reduction in median morphine equivalent dose (112.5 mg vs 225 mg, p<0.01), with no difference in median hospital length of stay (3 days vs 3 days, p=1.0) or 30-day readmission rate (9.4% vs 7.1%, p=0.66). There was no difference in patient-reported pain between the pre- and post-implementation cohorts on the day of discharge (severity 4.93 vs 5.14, p=0.53) or in any patient-reported symptoms, interference measures, or composite scores by post-discharge day 7. The median recovery time for most symptoms was 7 days, except for pain (14 days), fatigue (18 days), and physical interference (21 days), with no differences between cohorts. CONCLUSIONS: After implementation of a tiered opioid prescribing algorithm, the quantity and dose of discharge opioids prescribed decreased with no change in post-operative refills and without negatively impacting patient-reported symptom burden or interference, which can be used to educate and reassure patients and providers.

Assessment of physical function by subjective and objective methods in patients undergoing open gynecologic surgery.

OBJECTIVE: To evaluate the utility of patient-reported outcomes (PROs) to measure physical functioning in perioperative care for patients with gynecological (GYN) tumors. METHODS: 180 patients with GYN tumors undergoing open surgery participated in this longitudinal study. The physical functioning was measured by a subjective PRO tool, the Interference subscales of the MD Anderson Symptom Inventory (MDASI-I); as well as by an objective tool, the Timed Up & Go test (TUGT), perioperatively. Longer time (>20 s) needed to complete the TUGT was defined as "Prolonged". Patients completed EuroQoL-5D as well. The association between the scores of MDASI-I items and TUGT was assessed via the Spearman correlation coefficient. The known-group validity was assessed using the t-test and Cohen's D effect size. RESULTS: Compliance rates at preoperative, discharge and postoperative time points of MDASI-I were 98%, 95%, 96%; while TUGT completion rates were 92%, 75%, and 80%, respectively. Patients who had refused TUGT at discharge reported a significantly worse "MDASI-general activity" score compared to patients who completed TUGT (mean score of 7.00 vs. 5.38, P = 0.020). Patient-reported "Walking" on MDASI-I significantly differentiated patients with prolonged vs. those with frail/normal TUGT at discharge (mean score of 4.89 vs. 2.79, Cohen's d effect size = 0.82, P < 0.001). MDASI-I demonstrated excellent known-group validity per performance status and for the EuroQoL-5D subscales. CONCLUSION: Patient-reported physical functioning impairment after GYN surgery correspond with observed worse scores of the objective functioning measure test (TUGT). MDASI-I assessment represents a feasible and valid tool to evaluate functional status and warrants further implementation in the perioperative setting.

Impact of anesthesia technique on post-operative opioid use in open gynecologic surgery in an enhanced recovery after surgery pathway.

OBJECTIVE: To examine the effect of anesthesia technique in an enhanced recovery after surgery (ERAS) pathway on post-operative opioid use. METHODS: Patients undergoing open gynecologic surgery under an ERAS pathway from November 2014 through December 2018 were included retrospectively. All patients received pre-operative analgesia consisting of oral acetaminophen, pregabalin, celecoxib, and tramadol extended release, unless contraindicated. Patients received local wound infiltration with bupivacaine; the post-operative analgesic regimen was standardized. Patients were categorized by anesthesia technique: (1) inhalational, (2) total intravenous anesthesia (TIVA), and (3) combined technique. The primary outcome was post-operative opioid consumption measured as morphine equivalent dose, recorded as the total opioid dose received post-operatively, including doses received through post-operative day 3. RESULTS: A total of 1184 patients underwent general anesthesia using either inhalational (386, 33%), TIVA (349, 29%), or combined (449, 38%) techniques. Patients who received combined anesthesia had longer surgery times (p=0.005) and surgical complexity was higher among patients who underwent TIVA (moderate/higher in 76 patients, 38%) compared with those who received inhaled anesthesia (intermediate/higher in 41 patients, 23%) or combined anesthesia (intermediate/higher in 72 patients, 30%). Patients who underwent TIVA anesthesia consumed less post-operative opioids than those managed with inhalational technique (0 (0-46.3) vs 10 (0-72.5), p=0.009) or combined anesthesia (0 (0-46.3) vs 10 (0-87.5), p=0.029). Similarly, patients who underwent the combined technique had similar opioid consumption post-operatively compared with those who received inhalational anesthesia (10 (0-87.5) vs 10 (0-72.5), p=0.34). CONCLUSIONS: TIVA technique is associated with a decrease in post-operative consumption of opioids after open gynecologic surgery in patients on an ERAS pathway.

A prospective randomized trial comparing liposomal bupivacaine vs standard bupivacaine wound infiltration in open gynecologic surgery on an enhanced recovery pathway.

BACKGROUND: Value in healthcare is reflected by patient-centered outcomes of care per health dollar expended. Although liposomal bupivacaine is more expensive, it has been shown to provide prolonged analgesia (up to 72 hours). OBJECTIVE: This study aimed to evaluate whether the addition of liposomal bupivacaine to standard bupivacaine could decrease opioid intake and improve pain control after laparotomy for gynecologic surgery compared with standard bupivacaine alone in an enhanced recovery after surgery pathway. STUDY DESIGN: A prospective randomized controlled single-blinded trial of wound infiltration with liposomal bupivacaine plus 0.25% bupivacaine (study arm) vs 0.25% bupivacaine (control arm) was performed at a National Cancer Institute-designated tertiary referral cancer center. Participants were patients aged ≥18 years undergoing exploratory laparotomy for a gynecologic indication. All patients were treated on an enhanced recovery pathway including local wound infiltration before closure. In this study, 266 mg of liposomal bupivacaine (free base; equal to 300 mg bupivacaine HCL)+150 mg of bupivacaine mixed in the same syringe was used in the study arm, and 150 mg of bupivacaine was used in the control arm. The primary outcome was the proportion of patients who were opioid-free within 48 hours after surgery. Secondary outcomes included number of opioid-free days from postoperative day 0 to postoperative day 3, days to first opioid administration, morphine equivalent daily dose, and patient-reported outcomes collected with the MD Anderson Symptom Inventory. The MD Anderson Symptom Inventory was administered as a preoperative baseline, daily while hospitalized, and at least weekly for 8 weeks after discharge. All outcomes were prespecified before data collection. RESULTS: In this study, 102 patients were evaluated. Among them, 16.7% of patients in the study arm received no opioids up to 48 hours compared with 14.8% in the control arm (P=.99). There were no significant differences in the amount of intraoperative opioids administered or days to first opioid use. There was no significant difference between the 2 arms in median cumulative morphine equivalent daily dose (21.3 [study arm] vs 33.8 [control arm]; P=.36) or between the groups in morphine equivalent daily dose per individual day. There were no significant differences in patient-reported pain or interference with walking between the 2 arms or other patient-reported outcomes. CONCLUSION: Within an enhanced recovery after surgery pathway, adding liposomal bupivacaine to 0.25% bupivacaine wound infiltration did not decrease the proportion of patients who were opioid-free within 48 hours after surgery, did not decrease opioid intake, or did not improve patient's self-reported pain and functional recovery compared with standard bupivacaine.

Effect of preoperative intravenous vs oral acetaminophen on postoperative opioid consumption in an enhanced recovery after surgery (ERAS) program in patients undergoing open gynecologic oncology surgery.

OBJECTIVE: Both intravenous (IV) and oral acetaminophen provide effective opioid-sparing analgesia after surgery when used as part of a multimodal preemptive pain management strategy. The purpose of this study was to compare postoperative opioid consumption in patients undergoing open gynecologic oncology surgery who received preoperative IV vs oral acetaminophen within an enhanced recovery after surgery (ERAS) program. METHODS: Retrospective data were collected on consecutive patients undergoing open gynecologic oncology surgery from May 1, 2016 to February 28, 2018 in patients receiving either 1 g IV or oral acetaminophen preoperatively. Patients were given a preoperative multimodal analgesia regimen including acetaminophen, celecoxib, pregabalin and tramadol. The primary outcomes were morphine equivalent daily doses (MEDD) on postoperative days (POD) 0 and 1. Secondary outcomes included highest patient-reported pain score in the post-anesthesia care unit (PACU) and intraoperative MEDD. Regression models adjusted by matched pairs were fit to estimate the average treatment effect of IV vs oral acetaminophen on MEDD. RESULTS: Of 353 patients, 178 (50.4%) received IV acetaminophen and 175 (49.6%) received oral acetaminophen. When balancing across the matched samples, there was no difference in postoperative MEDD for POD 0 between the IV and oral acetaminophen groups (Beta = -1.11; 95% CI: -4.83 to 2.60; p = 0.56). On POD 1, there was no difference between the IV and oral groups (Beta = 2.24; 95% CI: -2.76 to 7.25; p = 0.38). CONCLUSIONS: There was no difference in postoperative opioid consumption between patients receiving preoperative IV or oral acetaminophen within an ERAS program for patients undergoing open gynecologic oncology surgery.

Longitudinal patient-reported outcomes and restrictive opioid prescribing after minimally invasive gynecologic surgery.

OBJECTIVE: To determine post-discharge patient-reported symptoms before and after implementation of restrictive opioid prescribing among women undergoing minimally invasive gynecologic surgery. METHODS: We compared clinical outcomes and symptom burden among a cohort of 389 women undergoing minimally invasive gynecologic surgery at a single institution before and after implementation of a restrictive opioid prescribing quality improvement initiative in July 2018. Post-discharge symptom burdens were collected up to 42 days after discharge using the MD Anderson Symptom Inventory and analyzed using linear mixed effects models. RESULTS: The majority of women included in this study were white non-smokers and the median age was 55 (range 23-83). Most women underwent hysterectomy (64%), had surgery for malignancy (71%), and were discharged from the hospital on the day of surgery (65%). Women in the restrictive opioid prescribing group had a median reduction in morphine equivalent dose prescribed at discharge of 83%, corresponding to a median reduction in 25 tablets of 5 mg oxycodone per person. There was no difference between opioid prescribing groups in either the rate of refill requests (P=1) or hospital re-admission (P=1) up to 30 days after discharge. After adjustment for co-variates, there was no statistically significant difference in post-discharge symptom burden including patient-reported pain (P=0.08), sleep (P=0.30), walking interference (P=0.64), activity interference (P=0.12), or affective interference (P=0.67). There was a trend toward less reported constiptation in the restrictive opioid prescribing group that did not reach statistical significance (P=0.05). CONCLUSION: We found that restrictive post-operative opioid prescribing was not associated with differences in longitudinal symptom burden among women undergoing minimally invasive gynecologic surgery. These results provide the most comprehensive picture to date of post-operative symptom recovery under different opioid prescribing approaches, lending additional support for existing recommendations to reduce opioid prescribing following gynecologic surgery.

Enhanced recovery for obese patients undergoing gynecologic cancer surgery.

OBJECTIVE: To compare post-operative length of stay and complication rates of matched obese and non-obese patients in an enhanced recovery (ERAS) program after open gynecologic cancer surgery. METHODS: We performed an observational cohort study of patients (n=1225) undergoing open surgery from November 2014 to November 2018 at a tertiary cancer center. Patients undergoing multidisciplinary procedures, non-oncologic surgery, or procedures in addition to abdominal surgery were excluded (n=190). Obese and non-obese patients were matched by date, age, disease status, and surgical complexity. The primary outcome was post-operative length of stay. Secondary outcomes included 30-day peri-operative complications, re-operation, re-admission, opioid use, and program compliance. RESULTS: After matching, 696 patients (348 obese, 348 non-obese) with median age of 57 years (IQR 48-66) were analyzed. Obese patients had a longer median procedure time (218 min vs 192.5 min, p<0.001) and greater median estimated blood loss (300 mL vs 200 mL, p<0.001). Median (IQR) post-operative length of stay was the same for obese and non-obese patients: 3 days (IQR 2-4). Obese and non-obese patients had similar rates of grade III-IV complications (10.9% and 6.6%, respectively, p=0.06), re-operation (2.3% and 1.4%, respectively, p=0.58), and re-admission (11.8% and 8.0%, respectively, p=0.13). Grade I-II complications were more common among obese patients (62.4% vs 48.3%, p<0.001) because they had more wound complications (17.8% vs 4.9%, p<0.001). Obese patients received more opioids both during surgery (morphine equivalent dose 57.25 mg (IQR 35-72.5) vs 50 mg (IQR 25-622.5), p=0.003) and after surgery (morphine equivalent daily dose 45 mg/day (IQR 10-96.2) vs 29.37 mg/day (IQR 7.5-70), p=0.01). Obese and non-obese patients had similar ERAS program compliance (70.1% and 69.8%, respectively, p=0.32). CONCLUSIONS: Neither post-operative length of stay nor the rate of serious complications differed significantly despite longer surgeries, greater blood loss, and more opioid use among obese patients. An ERAS program was safe, effective, and feasible for obese patients with suspected gynecologic cancer.