Merchea, Amit

Objective: To develop and analyze a risk-adjusted cumulative sum (RA-CUSUM) chart as a potential method to monitor individual surgeon performance in robotic total mesorectal excision (TME) for rectal cancer. Background: Currently, surgeons lack real-time tools to monitor and enhance their performance beyond residency completion. While national quality programs exist, granular, individual-level data are crucial for continuous improvement. Previous studies suggest cumulative sum charts hold promise in identifying performance trends and outliers. Methods: This retrospective study analyzed data from 640 robotic TME cases performed by 12 surgeons at 2 institutions. RA-CUSUM charts were generated for 3 outcomes: (1) complications, (2) operative time, and (3) length of stay. Results: The overall RA-CUSUM curves for operative time and complications showed an initial learning phase, followed by a plateau or downward slope, indicating proficiency or improvement. However, individual surgeon curves revealed significant heterogeneity. Three surgeons consistently excelled in operative time, while 5 minimized complications most effectively. Potential quality improvement could be implemented to drive performance toward positive outliers. No differences were found in unadjusted outcomes, including conversion, number of lymph nodes harvested, and positive circumferential margins. Conclusions: The RA-CUSUM chart is a promising method for identifying individual surgeon performance in robotic TME. It could help surgeons, teams, and leaders identify improvement areas and benchmark themselves against positive outliers. Further studies are needed to explore the potential of RA-CUSUM for implementing interventions to improve surgical quality.

Objective: This study aims to assess the costs of a same-day discharge (SDD) enhanced recovery pathway for diverting loop ileostomy (DLI) closure compared with a standard institutional enhanced recovery protocol. Background: Every year, 50,155 patients in the United States undergo temporary stoma reversal. While ambulatory stoma closure has shown promise, widespread adoption remains slow. This study builds on previous research, focusing on the costs of a novel SDD protocol introduced in 2020. Methods: A retrospective case-control study was conducted at Mayo Clinic, Rochester, Minnesota, and Mayo Clinic, Jacksonville, Florida, comparing patients undergoing SDD DLI closure from August 2020 to February 2023 to those in a matched cohort receiving standard inpatient enhanced recovery protocol. Patients were matched based on age, sex, american society of anesthesiologists score, surgery period, and hospital. Primary outcomes included direct hospitalization and additional costs in the 30 days postdischarge. Results: The SDD group (n = 118) demonstrated a significant reduction in median index episode hospitalization and 30-day postoperative costs compared with the inpatient group (n = 236), with savings of $4827 per patient. Complication rates were similar, and so were readmission and reoperation rates. Conclusions: Implementation of the SDD for DLI closure is associated with substantial cost savings without compromising patient outcomes. The study advocates for a shift towards SDD protocols, offering economic benefits and potential improvements in health care resource utilization.

Abstract Background Colorectal surgery in patients with inflammatory bowel disease (IBD) and cirrhosis is associated with high morbidity related to portal hypertension. Thought to reduce surgical risk, transjugular intrahepatic portosystemic shunt (TIPS) may be used to decrease portal pressures. In this study, we aimed to characterize surgical outcomes of patients with IBD and cirrhosis who underwent preoperative TIPS at a large tertiary care center. Methods We retrospectively identified patients with IBD and cirrhosis who had undergone TIPS between 2010-2023 for portal decompression prior to colorectal surgery. All other indications for TIPS led to patient exclusion. Demographic and medical data was collected, including surgical indication and portal pressure measurement. Data on surgical outcomes were compiled through chart review. Results We identified 10 patients (60% male) with IBD and history of decompensated cirrhosis who underwent preoperative TIPS for portal decompression (Table 1). Surgical indications were colonic dysplasia (50%), refractory IBD (50%), and stenosis or stricture (30%). All patients were deemed nonsurgical candidates due to significant surgical risk from portal hypertension. Following multidisciplinary coordination, patients underwent TIPS for portal decompression at a median of 47 days (IQR 34-80) prior to colorectal surgery. TIPS was associated with significant reduction in portal pressure (22.5 vs 18.5mmHg, p<0.01) and portosystemic gradient (12.5 vs 5.5mmHg, p<0.01) in all patients. Of 10 patients, 30% had TIPS-related complications (transient fluid overload and encephalopathy). In terms of surgical complications, 40% of patients required intraoperative blood transfusion (range: 1-4 units). Postoperatively, 30% of patients had surgical site bleeding and 10% had wound dehiscence, although none required reoperation. Systemic complications occurred in 30% of patients, with systemic signs of infection being the most common. Transaminitis (50%) and coagulopathy (40%) were also common. Median hospital stay was 7 days (IQR 5.5-9.3), with 40% of patients being readmitted within 30 days. Most common cause of readmission was systemic infection (75%), abdominal abscess (50%), or electrolyte abnormality (50%), with one patient requiring reoperation for wound dehiscence. Ninety-day and 1-year survival was 100% and 90% respectively. Conclusion In our series of patients with IBD and cirrhosis requiring surgery but deemed nonsurgical candidates, preoperative TIPS lead to portal decompression and facilitated successful surgical intervention despite heightened risk. Nevertheless, significant operative and postoperative complications were noted. Future studies are needed to determine optimal surgical timing following TIPS placement.

Abstract Background Recent evidence challenges the current standard of offering surgery to patients with ileocecal Crohn’s disease only when they present complications of the disease. Methods A retrospective, multicenter comparative analysis was performed including patients operated for primary ileocecal CD at 12 referral centers. Patients were divided in 2 groups, according to indication of surgery for inflammatory (ICD) or complicated (CCD) phenotype. Short-term results were compared. Patients operated on for primary isolated ileocaecal CD (last 50 cm of the terminal ileum and cecum), either for predominantly inflammatory phenotype or for complications of the disease (stricturing or fistulizing pattern), between January 2012 - December 2021 were considered eligible to participate in this study. Patients with previous abdominal procedures for CD, and patients who had activity of the disease in other intestinal segments other than the ileocaecal region at the time of surgery, were excluded from the study. Results 2013 patients were included, 291 (14.5%) in the ICD group. No differences were found between groups in time from diagnosis to surgery or in the levels of exposure to biologic drugs before indication of surgery. CCD patients had higher rates of low BMI, anemia (40.9 vs. 27%, p: < 0.001), and low albumin (11.3 vs. 2.6%, p: < 0.001). CCD patients had longer operations, lower rates of laparoscopic approach (84.3 vs. 93.1%, p: 0.001), and higher conversion rates (9.3 vs. 1.9%, p: < 0.001). CCD had longer hospital stay and higher postoperative complication rates (26.1 vs. 21.3%, p: 0.083). Anastomotic leakage and reoperations were also more frequent in this group. More patients in the CCD group required an extended bowel resection (14.1 vs. 8.3%, p: 0.017). In multivariate analysis, CCD was associated with prolonged surgeries (OR: 3.44, p: 0.001) and requirements of multiple intraoperative procedures (OR: 8.39, p: 0.030). Conclusion Indication of surgery in patients who present an inflammatory phenotype of CD was associated with better outcomes when compared to patients operated on for complications of the disease, without a difference between groups in time from diagnosis to surgery.

Abstract Background:Presacral tumors are a rare entity typically treated with an open surgical approach. A limited number of minimally invasive resections have been described. Aim of the study was to evaluate the safety and efficacy of robotic resection of presacral tumors. Methods: This was a retrospective single system analysis, conducted at a quaternary referral academic healthcare system, and included all patients who underwent a robotic excision of a presacral tumor between 2015 and 2023. Outcomes of interest were operative time, estimated blood loss, complications, length of stay, margin status, and recurrence rates. Results: Sixteen patients (11 females, 5 males) were included. Median age of the cohort was 51 years (range 25-69). Median operative time was 197 minutes (range 98-802). Median estimated blood loss was 40 ml, ranging from 0 to 1800 ml, with one patient experiencing conversion to open surgery after uncontrolled hemorrhage. Urinary retention was the only post-operative complication that occurred in 3 patients (19%) and was solved within 30 days in all cases. Median length of stay was one day (range 1-6). Median follow-up was 6.7 months (range 1-110). All tumors were excised with appropriate margins, but one benign and one malignant tumor recurred (12.5%). Ten tumors were classified as congenital (one was malignant), two were mesenchymal (both malignant), and five were miscellaneous (one malignant). Conclusions:Robotic resection of select presacral pathology is feasible and safe. Further studies must be conducted to determine complication rates, outcomes, and long-term safety profiles.

5554 Background: Epithelial ovarian cancer (EOC) is characterized by chemoresistant recurrences primarily confined to the intraperitoneal cavity, frequently leading to malignant small bowel obstructions. Intraperitoneal (IP) chemotherapy has been incorporated in EOC, but only in the first-line setting. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel IP drug delivery method that optimizes tissue penetration depth and drug distribution, to treat recurrent peritoneal malignancies. Recent trials outside the U.S. demonstrated partial to stable response following PIPAC in recurrent EOC. To date, no clinical trials have been completed investigating the role of PIPAC in EOC in the United States. Methods: We performed a multicenter prospective phase I trial using IP cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 via PIPAC at 6-week intervals. Patients were eligible if they had recurrent disease with peritoneal metastasis; extraperitoneal metastasis was allowed. The primary endpoint was dose-limiting toxicity (DLT). Secondary endpoints included progression free survival, PCI scoring, RECIST measurements, and quality of life (QoL). The patients with gastric and uterine cancers’ toxicity data were used but given inherent prognostic differences the treatment efficacy for these patients were not used in this analysis. Adverse event (AE) monitoring was graded using CTCAE spanning 18 weeks. Following completion of treatment (³2 PIPACs) patients were followed up every 12 weeks. QoL was measured using patient-reported assessments at 0, 6, 12, and 18 weeks. Baseline demographics were summarized. Mean change in PCI was calculated between cycle (C) 1 and 2, and cycle 2 and 3. Toxicities attributed to the surgery or PIPAC were reported with highest grade for each patient. Results: Nine heavily pretreated, recurrent patients were enrolled in the trial: 7 with platinum-resistant recurrent EOC, 1 with uterine cancer, and 1 with gastric cancer. PIPAC completion rate was 71.4%. Median age of participants was 65 years. Median prior lines of chemotherapy were 4 (range 2 - 10). No surgical complications occurred in the cohort. Two patients came off study: one for G3 abdominal pain and the other for G3 anorexia. For the EOC cohort, the median PCI reduction was -1.4% (C1 to C2) and -2.8% (C1 to C3). One low-grade serous EOC patient demonstrated a partial response based on RECIST criteria and received 6 cycles. Two EOC patients showed an initial response based on PCI reduction, but progressed following Cycle 2. Overall, QoL was stable. Conclusions: PIPAC with cisplatin/doxorubicin in platinum-resistant ovarian cancer is well tolerated. Intraperitoneal responses were seen in a subset of low-grade serous ovarian cancer patients, which may warrant further study. Heavily pretreated, platinum-resistant high-grade EOC patients derived limited intraperitoneal control from PIPAC monotherapy. Clinical trial information: NCT04329494 .

BACKGROUND: Acute diverticulitis in immunocompromised patients is associated with high morbidity and mortality rates with either medical or surgical treatment. Thus, management approach is controversial, especially for patients presenting with nonperforated disease. OBJECTIVE: This study aimed to report the Mayo clinic experience of acute diverticulitis management in immunocompromised patients. DESIGN: This design is based on a retrospective cohort study. SETTING: This study was conducted with institutional data composed from 3 tertiary referral centers. PATIENTS: Immunocompromised patients presenting with acute diverticulitis at 3 Mayo clinic sites between 2016 and 2020 were included. MAIN OUTCOME MEASURES: The main outcome measures were the management algorithm and short-term outcomes. RESULTS: Immunocompromised patients presenting with acute uncomplicated diverticulitis (86) were all managed nonoperatively at presentation with a success rate of 93% (80/86). Two patients (2.3%, 2/86) required surgery during the same admission, and 4 patients (4.8%, 4/84) had 30-day readmission. Complicated diverticulitis patients with abscess (22) were all managed nonoperatively first with a success rate of 95.4% (21/22). One patient (4.6%, 1/22) required surgery during the same admission. All the patients who presented with obstruction (2), fistula (1), or free perforation (11) underwent surgery except one who chose hospice. Overall, the major complication rate was 50% (8/16) and mortality rate was 18.8% (3/16) among patients who underwent surgery during the same admission. For patients who presented with perforated diverticulitis, the mortality rate was 27.3% (3/11), compared with 0% (0/111) for patients who presented with nonperforated disease. LIMITATIONS: This cohort was limited by its retrospective nature and heterogeneity of the patient population. CONCLUSIONS: Nonoperative management was safe and feasible for immunocompromised patients with colonic diverticulitis without perforation at our center. Perforated colonic diverticulitis in immunocompromised patients was associated with high morbidity and mortality rate. See Video Abstract at http://links.lww.com/DCR/B988. MANEJO DE LA DIVERTICULITIS AGUDA EN PACIENTES INMUNOCOMPROMETIDOS: EXPERIENCIA DE LA CLINICA MAYO ANTECEDENTES: La diverticulitis aguda en pacientes inmunocomprometidos se asocia con una alta tasa de morbilidad y mortalidad con el tratamiento médico o quirúrgico. Por lo tanto, el enfoque de manejo es controvertido, especialmente para pacientes que presentan enfermedad no perforada. OBJETIVO: El propósito fue informar la experiencia de la clínica Mayo en el manejo de la diverticulitis aguda en pacientes inmunocomprometidos. DISEÑO: Este es un estudio de cohorte retrospectivo ENTORNO CLÍNICO: Este estudio se realizó con datos institucionales compuestos de tres centros de referencia terciarios. PACIENTES: Se incluyeron pacientes inmunocomprometidos que presentaron diverticulitis aguda en tres sitios de la clínica Mayo entre 2016 y 2020. RESULTADO PRINCIPAL: Algoritmo de gestión y resultados a corto plazo. RESULTADOS: Los pacientes inmunocomprometidos que presentaban diverticulitis aguda no complicada (86) fueron tratados de forma no quirúrgica en la presentación inicial con una tasa de éxito del 93 % (80/86). Dos pacientes (2,3%, 2/86) requirieron cirugía durante el mismo ingreso y cuatro pacientes (4,8%, 4/84) tuvieron reingreso a los 30 días. Todos los pacientes con diverticulitis complicada con absceso (22) fueron tratados primero de forma no quirúrgica con una tasa de éxito del 95,4 % (21/22). Un paciente (4,6%, 1/22) requirió cirugía durante el mismo ingreso. Todos los pacientes que presentaron obstrucción (2), fístula (1) o perforación libre (11) fueron intervenidos excepto uno que optó por hospicio. La tasa global de complicaciones mayores fue del 50 % (8/16) y la tasa de mortalidad fue del 18,8 % (3/16) entre los pacientes que se sometieron a cirugía durante el mismo ingreso. Para los pacientes que presentaban diverticulitis perforada, la tasa de mortalidad fue del 27,3 % (3/11), en comparación con el 0 % (0/111) de los pacientes que presentaban enfermedad no perforada. LIMITACIONES: Esta cohorte estuvo limitada por su naturaleza retrospectiva y la heterogeneidad de la población de pacientes. CoNCLUSIÓNES: El manejo no quirúrgico fue seguro y factible para pacientes inmunocomprometidos con diverticulitis colónica sin perforación en nuestro centro. La diverticulitis colónica perforada en pacientes inmunocomprometidos se asoció con una alta tasa de morbilidad y mortalidad. Consulte Video Resumen en http://links.lww.com/DCR/B988. (Traducción— Dr. Ingrid Melo)

Abstract Objectives Peritoneal metastasis (PM) from appendiceal cancer or colorectal cancer (CRC) has significant morbidity and limited survival. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a minimally invasive approach to treat PM. We aim to conduct a dose-escalation trial of mitomycin C (MMC)-PIPAC combined with systemic chemotherapy (FOLFIRI) in patients with PM from appendiceal cancer or CRC. Methods This is a multicenter Phase I study of MMC-PIPAC (NCT04329494). Inclusion criteria include treatment with at least 4 months of first- or second-line systemic chemotherapy with ineligibility for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). Exclusion criteria are: progression on chemotherapy; extraperitoneal metastases; systemic chemotherapy intolerance; bowel obstruction; or poor performance status (ECOG>2). Escalating MMC-PIPAC doses (7–25 mg/m 2 ) will be administered in combination with standard dose systemic FOLFIRI. Safety evaluation will be performed on 15 patients (dose escalation) and six expansion patients: 21 evaluable patients total. Results The primary endpoints are recommended MMC dose and safety of MMC-PIPAC with FOLFIRI. Secondary endpoints are assessment of response (by peritoneal regression grade score; Response Evaluation Criteria in Solid Tumors [RECIST 1.1], and peritoneal carcinomatosis index), progression free survival, overall survival, technical failure rate, surgical complications, conversion to curative-intent CRS-HIPEC, patient-reported outcomes, and functional status. Longitudinal blood and tissue specimens will be collected for translational correlatives including pharmacokinetics, circulating biomarkers, immune profiling, and single-cell transcriptomics. Conclusions This Phase I trial will establish the recommended dose of MMC-PIPAC in combination with FOLFIRI. Additionally, we expect to detect an early efficacy signal for further development of this therapeutic combination.

Abstract Background Minimally invasive surgery (MIS) is the first-line approach for ileocolic resection in patients with Crohn’s disease (CD) and it is safe and feasible even in complex cases. However, an open approach is still required, but indications to open ileocolic resection for CD are not well described. Methods All consecutive adult patients with CD who underwent elective ileocolic resection in the Departments of Colon and Rectal Surgery at Mayo Clinic Rochester, Minnesota and Jacksonville, Florida between September 2014 and March 2021 were included and divided into “open” and “MIS” groups. Open approach was defined as upfront laparotomy, MIS included laparoscopic and robotic approaches, and conversion was defined as incision made earlier than planned. Indications to open approach were retrospectively reviewed by two authors, and any incongruity was resolved. Analogous indications were also assessed in the MIS group, as appropriate. Indications, baseline, perioperative characteristics, and short-term postoperative outcomes were compared between open and MIS. Results Among 319 ileocolic resections for CD, 45 (14.1%) were open and 274 (85.9%) MIS. Indications for open approach were severe disease, adhesions at previous surgery, history of abdominal sepsis, multifocal and extensive disease, abdominal wall involvement, concomitant open procedures, small bowel dilatation, and anaesthesiologic contraindications (Table 1). In addition, two or more of the above indications were present in 40 patients (89%) in the open group, while only in 6 patients (2%) in the MIS group (p<0.001). Compared to MIS patients, patients undergoing open ileocolic resection were older, with longer CD duration, more previous surgery and preoperative intra-abdominal abscess drainage (Table 2). Nine patients were converted in the MIS group (3.3%). Intraoperatively, open group had more adhesiolysis ≥45 min, more intraoperative complications, more blood loss, more primary stoma, less anastomosis, and longer operative time (Table 3). Postoperatively, they had more overall postoperative complications, ileus, surgical site infections, dehydration, vascular thromboembolism, higher severity by Clavien-Dindo classification, and longer length of stay (Table 4). Conclusion Overall rate of open approach ileocolic resection for CD was 14 % during a 7-years period in a referral centre. Open approach was the only operation performed in cases of abdominal wall involvement, concomitant open procedures, and anaesthesiologic contraindication. In addition, the presence of at least two indications,predicting high technical complexity, may be considered as a no-go for the MIS approach in ileocolic resections for CD.

125 Background: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is being evaluated as a novel minimally invasive palliative treatment of peritoneal metastases (PM). Prior studies have established the feasibility and safety of repeated PIPAC treatments in gastrointestinal and gynecologic cancers. The goal of the present phase 1 trial was to establish the safety and feasibility of PIPAC oxaliplatin in a highly chemotherapy refractory colorectal and appendiceal cancer patient population. Methods: Patients with biopsy-proven peritoneal metastases from colorectal or appendiceal cancer underwent up to three PIPAC treatments using oxaliplatin (92 mg/m2) with a six-week interval at two academic centers. Patients with bowel obstruction, extra-peritoneal metastases, or poor performance status (ECOG>2) were excluded. PIPAC was nebulized over 5 min with a 30 min aerosol dwell time. Apart from the first PIPAC cycle, the patients also received a sensitizing dose of 5FU/LV (400mg/m2) within 24 hours of the procedure. Primary end point was safety as assessed by dose limiting toxicities within 6 weeks of the first PIPAC. Secondary endpoints included safety with the addition of 5FU/LV, efficacy, surgical morbidity, technical failure rate, progression-free and overall survival, pharmacokinetics (PK), and quality of life assessment. Results: A total of 8 patients were included: 5 colorectal; and 3 appendiceal. Median number of prior chemotherapy cycles was 2 (Interquartile range – IQR; 1.5-3.5). All patients were refractory to systemic oxaliplatin-based chemotherapy. Median time from diagnosis to PIPAC was 16 months (IQR; 5.6, 17.5) and Peritoneal Carcinomatosis Index was 29 (IQR; 20.5, 31.5). Five (62.5%) patients completed 3 PIPAC cycles while in 3 (37.5%) patients PIPAC was discontinued due to disease progression within the peritoneal cavity. No surgical complication or dose limiting toxicity was observed. Only one patient developed grade 3 treatment-related toxicity after first PIPAC (anemia), and another patient after second PIPAC (abdominal pain and anemia). At the completion of PIPAC treatment 5 patients had stable disease and 3 had disease progression. Pharmacokinetic, histologic response and preliminary survival data will be presented at the meeting. Conclusions: PIPAC with oxaliplatin is safe and feasible in a highly chemotherapy refractory cohort of appendiceal and colorectal carcinomatosis patients with or without sensitizing 5-FU/ LV. Clinical trial information: NCT04329494.