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.

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.

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.

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.

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.

Patient characteristics and opioid use prior to discharge after open gynecologic surgery in an enhanced recovery after surgery (ERAS) program.

OBJECTIVE: To identify clinical and demographic characteristics associated with the absence of opioid usage on the day before discharge among patients undergoing open gynecologic surgery within an enhanced recovery after surgery (ERAS) program. METHODS: This was a single institution retrospective cohort study including all patients who underwent elective open gynecologic surgery as part of an ERAS program between November 1, 2014 and September 30, 2018 and who were discharged between post-operative day 2 and 7. Patients were excluded if they reported pre-existing chronic opioid use or underwent total pelvic exenteration. Descriptive statistics were used and multivariable logistic regression was used to identify factors associated with the absence of opioid usage on the day before discharge, after adjustment for relevant covariates. RESULTS: A total of 971 were included with a median length of stay of 3 days, and of these 526 (54.2%) used opioids on day before discharge and 445 (45.8%) did not. Absence of opioid use on the day before discharge was associated with age (P < .001), race (P = .04), Charlson Co-morbidity Index (P < .001), marital status (P = .004), and smoking status (P = .002) by univariate analysis. In a multivariable model, older age (adjusted OR 1.04; 95% CI 1.02-1.06; P < .001), current smoker status (adjusted OR 0.42; 95% CI 0.20-0.81; P = .01), and white or Caucasian race (adjusted OR 0.59; 95% CI 0.38-0.91; P = .02) were significantly associated with the absence of opioid use on the day prior to discharge. CONCLUSIONS: Nearly half of patients undergoing open gynecologic surgery within an established ERAS program did not consume any opioids on day before discharge. Safe, evidence-based reductions in post-operative opioid prescribing may be feasible for a subset of gynecologic surgery patients.

Primary Ewing Sarcoma/Primitive Neuroectodermal Tumor of the Kidney: The MD Anderson Cancer Center Experience.

Limited information exists on the clinical behavior of the Ewing sarcoma family of tumors (ESFT) of the kidney. We reviewed the records of 30 patients (aged 8-69 years) with ESFT of the kidney seen at our institution between 1990 and 2013. We analyzed the event-free survival (EFS) and overall survival (OS) for associations with patient demographics, disease group, tumor size, tumor thrombus, and treatment. Six patients (20%) had tumors confined to the kidney (Group I), seven (23.3%) had local tumor extension beyond the kidney (Group II), and 17 (56.7%) had distant metastasis at diagnosis (Group III). Twenty-five (83.3%) patients underwent radical (19 upfront, five delayed) or partial (one upfront) nephrectomy, 25 (83.3%) chemotherapy and four (13.3%) radiotherapy. The 4-year EFS and OS were 43% (95% CI, 26-61%) and 63% (95% CI, 46-81%), respectively. EFS and OS were significantly associated with disease group and chemotherapy (p < 0.039). The presence of tumor thrombus in renal vein and/or inferior vena cava was associated with worse EFS (p = 0.053). Patients with disease confined to the kidney treated with nephrectomy and adjuvant chemotherapy have favorable outcomes. Local tumor extension beyond the kidney, tumor thrombus, and distant metastasis are unfavorable factors that warrant intensification or novel approaches of therapy.

Effectiveness of low-dose radiation for primary cutaneous anaplastic large cell lymphoma.

PURPOSE: Primary cutaneous anaplastic large cell lymphoma (pcALCL) is conventionally treated with radiation therapy (RT) doses ≥30 GGy, but effectiveness of lower doses is unclear. We compared responses after a range of RT doses for pcALCL. METHODS AND MATERIALS: From 1999 through 2015, 45 lesions in 21 patients met clinicopathologic pcALCL diagnostic criteria and were treated with RT (<20 Gy, 20-29 Gy, or ≥30 Gy dose). Complete clinical (CR) and partial responses (PR) were compared by dose using Fisher exact test. Progression-free and overall survivals were calculated using the Kaplan-Meier method. RESULTS: Forty-two percent of lesions were treated with <20 Gy, 22% with 20 to 29 Gy, and 35% with ≥30 Gy. Within 12 weeks, 100% responded, with 67% CR and 33% PR; by last follow-up, 87% achieved CR and 13% PR (no difference by RT dose; P = .84). Three-year freedom from local relapse was 100%, 86%, and 100% with <20 Gy, 20 to 29 Gy, and ≥30 Gy, respectively (P = .28). Many patients ultimately demonstrated other cutaneous or systemic relapse, with 55% 3-year and 29% 10-year progression-free survival. Overall survival at 10 years was 59%, with 2 deaths from complications of disease. CONCLUSIONS: Low-dose RT offered excellent local control in the setting of the indolent, chronic course of pcALCL in this patient cohort.

Chemotherapy Response Assessment by FDG-PET-CT in Early-stage Classical Hodgkin Lymphoma: Moving Beyond the Five-Point Deauville Score.

PURPOSE: In early-stage classical Hodgkin lymphoma, fluorodeoxyglucose positron emission tomography (PET)-computed tomography (CT) scans are performed routinely after chemotherapy, and the 5-point Deauville score is used to report the disease response. We hypothesized that other PET-CT parameters, considered in combination with Deauville score, would improve risk stratification. METHODS AND MATERIALS: Patients treated for stage I to II Hodgkin lymphoma from 2003 to 2013, who were aged ≥18 years and had analyzable PET-CT scans performed before and after chemotherapy, were eligible. The soft tissue volume (STV), maximum standardized uptake value, metabolic tumor volume, and total lesion glycolysis were recorded from the PET-CT scans before and after chemotherapy. Reductions were defined as 1 - (final PET-CT value)/(corresponding initial PET-CT value). The primary endpoint was freedom from progression (FFP). RESULTS: For 202 patients treated with chemotherapy with or without radiation therapy, the 5-year FFP was 89% (95% confidence interval 85%-93%). All PET-CT parameters were strongly associated with the Deauville score (P<.001) and FFP (P<.0001) on univariate analysis. The Deauville score was highly predictive of FFP (C-index 0.89) but was less discriminating in the Deauville 1 to 4 subset (C-index 0.67). Therefore, we aimed to identify PET-CT parameters that would improve risk stratification for this subgroup (n=187). STV reduction was predictive of outcome (C-index 0.71) and was dichotomized with an optimal cutoff of 0.65 (65% reduction in STV). A model incorporating the Deauville score and STV reduction predicted FFP more accurately than either measurement alone in the Deauville 1 to 4 subset (C-index 0.83). The improvement in predictive accuracy of this composite measure compared with the Deauville score alone met statistical significance (P=.045). CONCLUSIONS: The relative reduction in tumor size is an independent predictor of outcome. Combined with the Deauville score, it might improve risk stratification and contribute to response-adapted individualization of therapy.

Does Bleomycin Lung Toxicity Increase the Risk of Radiation Pneumonitis in Hodgkin Lymphoma?

PURPOSE: Bleomycin pulmonary toxicity (BPT) is a well-known complication of treatment in patients with Hodgkin lymphoma (HL). We undertook the present study to investigate the risk of radiation pneumonitis (RP) in the setting of BPT and to determine the need for delay or omission of radiation therapy (RT) in these patients. METHODS AND MATERIALS: We identified 123 HL patients treated with ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine) followed by RT to the chest from January 2009 to December 2014. The medical records were reviewed for clinical, pathologic, and treatment information and toxicities. Our primary outcome was RP of any grade. Univariate and multivariate analyses were used to assess the association of BPT, baseline patient characteristics, and treatment variables with the incidence of RP. RESULTS: A total of 123 patients were included, of whom 99 (80%) received consolidation intensity modulated RT after ABVD treatment. We identified 31 patients (25.2%) with BPT after frontline ABVD. Seventeen patients (13.8%) developed RP a median of 8 weeks (range 1-39) after RT completion. BPT did not correlate with the risk of developing RP (P=.36). We evaluated the RP outcomes with respect to the bleomycin to RT interval (≤6 weeks vs >6 weeks), and we found that this interval did not predict for RP risk (P=.60). Dosimetric parameters such as the volume covered by 5 Gy and the mean lung dose were analyzed. A volume covered by 5 Gy of >55% and mean lung dose >13.5 Gy increased the risk of RP by 1.14-fold (P=.002) and 4.24-fold (P=.007), respectively. CONCLUSIONS: The results of our study suggest that BPT does not increase the risk of developing RP. Furthermore, RT initiation does not need to be delayed after chemotherapy, except to allow for the completion of steroid therapy or clinical recovery from BPT.