Research

The FIRST Program supports a diverse portfolio of clinical research projects across all surgical specialties. We provide comprehensive support and guidance to hundreds of clinical research projects, including biorepositories, industry-sponsored clinical trials, medical record review studies, and prospective observational cohort studies. Our expertise and resources support surgical faculty at every stage, from study design and regulatory submissions to data collection and analysis. By facilitating and streamlining processes, the FIRST Program enables investigators to conduct innovative research that advances patient care.

Recent Publications

  • Gershman B, Ernandez J, Kaul S, et al. Comprehensive characterization of the real-world perioperative morbidity of radical cystectomy in older adults.. Journal of geriatric oncology. 2025;16(6):102265. doi:10.1016/j.jgo.2025.102265

    INTRODUCTION: The perioperative morbidity of radical cystectomy (RC) is a critical factor for optimal decision-making in older adults with bladder cancer (BC). However, existing literature is dated and does not focus on older adults. We aimed to examine the real-world, perioperative morbidity of RC among older adults with BC.

    MATERIALS AND METHODS: We identified 6041 patients aged 66-89 years diagnosed with TanyNanycM0 urothelial bladder cancer from 2000 to 2017 who underwent RC in SEER-Medicare. Rates of perioperative morbidity and healthy days at home (HDAH) were examined using Medicare claims. The associations between baseline characteristics and each outcome were evaluated using logistic regression and negative binomial regression.

    RESULTS: The perioperative morbidity of RC is substantial, with 3859 (64 %) patients experiencing a complication during hospitalization or one requiring care utilization post-discharge. A total of 1764 (29 %) patients required ER evaluation within 90 days of surgery, and 2637 (44 %) were readmitted to the hospital. The median number of HDAH was 78 (interquartile range 66-82). Adjusted multivariable analyses demonstrated that a higher Charlson Comorbidity Index (CCI) and higher census tract poverty level were associated with increased risk of 90-day inpatient readmission, while older age, Black race, higher CCI, and lower annual hospital RC volume were associated with increased risk of 90-day complications.

    DISCUSSION: The real-world perioperative morbidity of RC in older adults is substantial and even greater than reported in prior institutional studies, with 44 % of patients requiring hospital-based care within 90 days of surgery. These observations inform clinical counseling of older adults with bladder cancer.

  • Gershman B, Ernandez J, Kaul S, et al. Associations of a claims-based frailty index with perioperative outcomes and survival among older adults undergoing radical cystectomy for bladder cancer.. Urologic oncology. Published online 2025. doi:10.1016/j.urolonc.2025.04.009

    OBJECTIVE: Frailty is increasingly recognized as an important component of geriatric assessment in older adults and an important predictor of clinical outcomes. Bladder cancer (BC) is a potentially lethal disease, and treatments like radical cystectomy (RC) are associated with high rates of morbidity. We examined the associations of baseline frailty with perioperative outcomes and survival in a population-based cohort of older adults undergoing RC.

    MATERIALS AND METHODS: We identified older adults aged 66 to 89 years with Tany Nany cM0 urothelial carcinoma of the bladder who underwent RC from 2000 to 2017 in SEER-Medicare. Baseline frailty was assessed using the claims-based frailty index (CFI), a validated deficit accumulation frailty measure, within the 12-months preceding surgery. The associations of CFI with perioperative outcomes and survival were evaluated using multivariable regression models.

    RESULTS: A total of 6,041 patients were included in the study cohort, including 2,640 (44%) who were robust (CFI <0.15), 2,980 (49%) who were prefrail (CFI 0.15-<0.25), and 421 (7%) who were mildly to severely frail (CFI ≥0.25). Increasing CFI was associated with statistically significantly higher rates of prolonged hospitalization, 90-day emergency department utilization, 90-day complications, and 90-day hospital readmission, and fewer healthy days at home (HDAH). CFI remained independently associated with an increased risk of perioperative outcomes and worse mortality in multivariable regression models.

    CONCLUSIONS: In a national, contemporary cohort of older adults with BC undergoing RC, increasing frailty was independently associated with a higher risk of perioperative morbidity, fewer HDAH, and worse mortality. The CFI provides an objective assessment to improve decision-making in older adults with bladder cancer.

  • Pan JM, Ospina-Delgado D, Kaul S, et al. Preoperative Workup of Patients With Excessive Central Airway Collapse: Does Stent Evaluation Serve a Role?. Journal of bronchology & interventional pulmonology. 2024;31(2):146-154. doi:10.1097/LBR.0000000000000935

    BACKGROUND: Tracheobronchoplasty (TBP) is a definitive anatomic intervention for patients with severe symptomatic expiratory central airway collapse. Although stent evaluations have been described for surgical workup, current literature does not address if improvement during stent evaluation is sustained after TBP. We compared health-related quality of life (HRQOL) and functional status responses after airway stenting to those post-TBP.

    METHODS: A retrospective review was performed in patients with severe expiratory central airway collapse who underwent stent evaluation followed by TBP from January 2004 to December 2019. Baseline, poststent, 3- and 12-month postoperative HRQOL scores, and functional status were analyzed with statistical tests as appropriate.

    RESULTS: One hundred twenty patients underwent a stent evaluation and TBP. Baseline and stent evaluation measurements were compared with statistically and clinically significant differences in the Cough Quality-of-life Questionnaire (CQLQ) (55 vs. 68, P <0.01), Modified Medical Research Council (mMRC) 0 to 2 (90% vs. 47%, P <0.01), 6-minute walk test (6MWT) (1301 ft vs. 1138 ft, P <0.01). Improvements in the HRQOL and functional status were maintained from stent evaluation to 3 months postoperatively [CQLQ 55 vs. 54, P =0.63; mMRC 0 to 2 (87% vs. 84%), P =0.39; 6MWT 1350 ft vs. 1314 ft, P =0.33], and 12 months postoperatively [CQLQ 54 vs. 54, P =0.91; mMRC 0 to 2 (95% vs. 86%), P =0.74; 6MWT 1409 ft vs. 1328 ft, P =0.13]. The magnitude of change between the data was not significantly different between the stent evaluation, 3-, and 12 months postoperative. Predicted forced expiratory volume in 1-second measurements at baseline, after stent placement, 3 months, and 12 months post-TBP were 74%, 79%, 73%, and 73%, respectively, and not clinically significant.

    CONCLUSIONS: Improvement after stent evaluation and the magnitude of improvement may be predictive of postoperative outcomes up to 1 year after surgery.

  • Background: Distinguishing between organ-confined disease and extraprostatic extension (EPE) is crucial for the treatment of patients with prostate cancer. EPE is associated with an increased risk of biochemical recurrence, positive surgical margins, and metastatic disease. An MRI-based EPE scoring system was developed by Mehralivand in 2019; however, it has not been adopted in the Urology community. The purpose of this study is to evaluate the association of MRI-based EPE scoring with the pathologic EPE (pEPE) after radical prostatectomy. Methods: We conducted a retrospective review on a prospectively collected database of male patients who underwent a prostate MRI with EPE scoring by a trained genitourinary radiologist and subsequent robotic radical prostatectomy at our institution from September 2020 to December 2022. The associations between MRI EPE (mEPE) score and the presence of EPE on surgical pathology (pEPE) were examined using multivariable logistic regression. Results: A total of 194 patients met inclusion criteria with a median age of 63 years and prostate specific antigen (PSA) 7 ng/mL. Among those with mEPE score 3, 96% had pEPE. Those patients with an mEPE score ≥2 had an increased risk of pEPE compared with those with mEPE score 0 (odds ratio 3.79; 95% confidence interval 1.28-11.3) Furthermore, those with an mEPE score 3 were significantly more likely to have pEPE compared with those with mEPE score 0, 1 and 2 independently. Conclusion: MRI EPE is a straightforward tool that strongly correlates with the presence of pEPE. If validated prospectively, this scoring system could assist in counseling patients regarding nerve-sparing approach.

  • Escobar AJ, Krishna S, Flowers M, et al. Practical Use of Self-Adjusted Nitrous Oxide During Transrectal Prostate Biopsy: A Double-Blind Randomized Controlled Trial.. The Journal of urology. 2024;211(2):214-222. doi:10.1097/JU.0000000000003789

    PURPOSE: Transrectal prostate biopsy is a common ambulatory procedure that can result in pain and anxiety for some men. Low-dose, adjustable nitrous oxide is increasingly being used to improve experience of care for patients undergoing painful procedures. This study seeks to evaluate the efficacy and safety of low-dose (<45%) nitrous oxide, which has not been previously established for transrectal prostate biopsies.

    MATERIALS AND METHODS: A single-institution, prospective, double-blind, randomized, controlled trial was conducted on patients undergoing transrectal prostate biopsies. Patients were randomized to receive either self-adjusted nitrous oxide or oxygen, in addition to routine periprostatic bupivacaine block. Nitrous oxide at levels between 20% and 45% were adjusted to patients' desired effect. Patients completed a visual analog scale for anxiety, State Trait Anxiety Inventory, and a visual analog scale for pain immediately before and after biopsy. The blinded operating urologist evaluated ease of procedure. Periprocedural vitals and complications were assessed. Patients were allowed to drive home independently.

    RESULTS: A total of 133 patients received either nitrous oxide (66) or oxygen (67). There was no statistically significant difference in the primary anxiety end point of State Trait Anxiety Inventory or the visual analog scale for anxiety scores between the nitrous oxide and oxygen groups. However, patients in the nitrous oxide group reported significantly lower visual analog scale for pain scores compared to the oxygen group (P = .026). The operating urologists' rating of tolerance of the procedure was better in the nitrous oxide group (P = .03). There were no differences in biopsy performance time. Complications were similarly low between the 2 groups.

    CONCLUSIONS: Patient-adjusted nitrous oxide at levels of 20% to 45% is a safe adjunct during transrectal prostate biopsy. Although there was not an observed difference in the primary end point of anxiety, nitrous oxide was associated with lower patient-reported pain scores.

  • Huang VW, DeVore EK, Kaul S, Parikh M, Hayes MM, Teng SE. Valves for the Voiceless: Time to Speaking Valve Use in Posttracheostomy Patients After Multidisciplinary Initiative.. Otolaryngology–head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery. 2025;172(2):710-716. doi:10.1002/ohn.1016

    OBJECTIVE: To review speaking valve (SV) use at a tertiary academic medical center and determine whether a multidisciplinary team implementation of SV protocols increased SV use and decreased time to SV trials.

    METHODS: Retrospective case series of patients who underwent a tracheostomy between 2017 and 2023 before and after the dissemination of new protocols from a new multidisciplinary tracheostomy care initiative in 2019. The calendar days between meeting SV eligibility criteria and initial trial of SV were compared. Eligibility criteria for SV was defined as any patient ≥48 hours posttracheotomy who can breathe unassisted, off mechanical ventilation, tolerate a deflated cuff, and participate in an evaluation. Interrupted time series analysis using segmented negative binomial regression assessed the change in time to SV placement before and after protocol implementation.

    RESULTS: A total of 421 patients were identified. After new protocols were disseminated, eligible patients with a SV trial increased from 75% to 95% with an increase in percentage of patients who tolerated the SV on their first attempt from 60% to 75%. Interrupted time series analysis demonstrated protocol implementation was associated with an overall 80% decrease in time to SV placement.

    DISCUSSION: Continued barriers to SV implementation such as elevated tracheal pressures due to large tracheostomy sizes, or inappropriately early consultations with patients unable to participate in SV exam, may be amenable to further institution-level quality improvement initiatives.

    IMPLICATIONS FOR PRACTICE: A multidisciplinary initiative's dissemination of protocols with algorithms for SLP consultation and SV use can help standardize post-operative tracheostomy care.