Early Quality of Life Assessment After Segmental Colorectal Resection for Deep Infiltrating Endometriosis.

STUDY OBJECTIVE: Endometriosis is a benign condition afflicting women of reproductive age that significantly impacts their quality of life (QoL). Given its debilitating symptoms and prevalence, it is essential to define its proper management. In this study, we have assessed patient-reported outcomes among women having undergone segmental colorectal resection for deep infiltrating endometriosis. Any correlation between preoperative nutritional status and overall postoperative complications has also been analyzed. STUDY DESIGN: Prospective observational study. SETTING: Public medical center. PATIENTS: One hundred forty consecutive patients that had undergone segmental colorectal resection for DIE between November 2020 and October 2021 at IRCCS Sacro Cuore Don Calabria Hospital of Negrar of Valpolicella (Verona, Italy). INTERVENTIONS: Patient-reported outcomes were measured using data collected from the MD Anderson Symptom Inventory for gastrointestinal surgery patients and Euro-QoL Group EQ-5D-5L (EQ-5Q-5L) questionnaires, which were administered preoperatively (T0), at discharge (T1) and at 4 to 6 weeks after surgery (T2). Nutritional status was examined through the Mini Nutritional Assessment Short form and Prognostic Nutritional Index. MEASUREMENTS AND MAIN RESULTS: A significant improvement in the EQ-5Q-5L and MDASI-GI scores was noted between T0 and T2 (p <. 001 and p <. 001, respectively.) No statistically significant differences were found in scores at T2 between patients who had experienced postoperative complications and those who had not. No statistically significant association was observed between the presence of malnutrition and overall postoperative complications and their severity. CONCLUSION: This study confirms, through patient-reported outcomes, the pivotal role of surgery in improving the QoL at 4 to 6 weeks of women affected by endometriosis who have previously been unresponsive to medical therapy.

iColon, a patient-focused mobile application for perioperative care in colorectal surgery: Results from 444 patients.

AIM: The aim of this study is to assess if a patient-focused mobile application can increase compliance with active Enhanced Recovery After Surgery (ERAS) items and thereby improve surgery-related outcomes and patient satisfaction. METHOD: This is a prospective observational study of patients admitted for elective colorectal surgery, under the ERAS protocol, and having access to the mobile application iColon during all perioperative phases. RESULTS: The 444 participants were included in the study. The overall adherence to the use of iColon was 62.4%. The overall adherence to active ERAS items was 74.1%. Adherence to the use of iColon significantly impacted adherence to active ERAS items. The use of the application was negatively related with factors such as age, type of disease, and postoperative complications. In the postdischarge phase, low adherence to active ERAS items typically indicates an increased likelihood of readmission; however, the use of iColon correlated significantly with a reduction in the 30-day readmission rate. A survey regarding patient satisfaction and confidence in using iColon resulted in positive feedback in more than 94% of cases, while 92.7% reported better quality of care. CONCLUSION: Our findings suggest that digital health tools are beneficial and effective in the follow up of patients after early discharge. Our mobile application, iColon, represents user-friendly technology that is well-accepted. It has real-world implications in increasing adherence to active ERAS items, which results in an improvement in perceived quality of care by its users.

Sexual, urinary, and intestinal dysfunction after rectal surgery: pre-, intra-, and post-operative predictors and trends over time in a single high-volume center.

The incidence of long-term complications after rectal surgery varies widely among studies, and data regarding functional sequelae after transanal surgery are lacking. The aim of this study is to describe the incidence and change over time of sexual, urinary, and intestinal dysfunction in a single-center cohort, identifying independent predictors of dysfunction. A retrospective analysis of all rectal resections performed between March 2016 and March 2020 at our institution was conducted. Validated questionnaires were administered to assess post-operative function. Predictors of dysfunction were assessed by univariate and multivariate analysis. Latent class analysis was used to distinguish different risk profile classes. One hundred and forty-five patients were included. Sexual dysfunction at 1 month rose to 37% for both sexes, whereas urinary dysfunction reached 34% in males only. A significant (p < 0.05) improvement in urogenital function was observed between 1 and 6 months only. Intestinal dysfunction increased at 1 month, with no significant improvement between 1 and 12 months. Independent predictors of genitourinary dysfunction were post-operative urinary retention, pelvic collection, and Clavien-Dindo score ≥ III (p < 0.05). Transanal surgery resulted an independent predictor of better function (p < 0.05). Transanal approach, Clavien-Dindo score ≥ III, and anastomotic stenosis were independent predictors of higher LARS scores (p < 0.05). Maximum dysfunction was found at 1 month after surgery. Improvement was earlier for sexual and urinary dysfunction, whereas intestinal dysfunction improved slower and depended on pelvic floor rehabilitation. Transanal approach was protective for urinary and sexual function, although associated with a higher LARS score. Prevention of anastomosis-related complications resulted protective of post-operative function.

Open pancreaticoduodenectomy: setting the benchmark of time to functional recovery.

PURPOSE: No accepted benchmarks for open pancreaticoduodenectomy (PD) exist. The study assessed the time to functional recovery after open PD and how this could be affected by the magnitude of midline incision (MI). MATERIALS AND METHODS: Prospective snapshot study during 1 year. Time to functional recovery (TtFR) was assessed for the entire cohort. Further analyses were conducted after excluding patients developing a Clavien-Dindo ≥ 2 morbidity and after stratifying for the relative length of MI. RESULTS: The overall median TtFR was 7 days (n = 249), 6 days for uncomplicated patients (n = 124). A short MI (SMI, < 60% of xipho-pubic distance, n = 62) was compared to a long MI (LMI, n = 62) in uncomplicated patients. The choice of a SMI was not affected by technical issues and provided a significantly shorter TtFR (5 vs 6 days, p = 0.002) especially for pain control (4 vs. 5 days, p = 0.048) and oral food intake (5 vs. 6 days, p = 0.001). CONCLUSION: Functional recovery after open PD with MI is achieved within 1 week from surgery in half of the patients. This should be the appropriate benchmark for comparison with minimally invasive PD. Moreover, PD with a SMI is feasible, safe, and associated with a faster recovery.

Redefining the Role of Drain Amylase Value for a Risk-Based Drain Management after Pancreaticoduodenectomy: Early Drain Removal Still Is Beneficial.

BACKGROUND: The application of postoperative pancreatic fistula (POPF) risk stratification and mitigation strategies requires an update of the protocol for an early drain removal after pancreaticoduodenectomy (PD). The aim of the study is to highlight the unreliability of a single drain fluid amylase (DFA) cutoff-based protocol in the setting of a risk-based drain management. METHODS: The role of postoperative day one (POD1) DFA in predicting POPF was explored in the setting of both selective drain placement and early drain removal protocols. Receiver operating characteristics (ROC) curves were used to assess the POPF diagnostic performance in terms of negative predictive value (NPV) of several POD1 DFA cutoffs in different clinical scenarios according to POPF risk and mitigation strategies. RESULTS: The areas under the curve (AUCs) for POD1-DFA were 0.815 for intermediate risk and pancreaticojejunostomy (PJ) (best cutoff 1000 IU/L, NPV 92.9%), 0.712 for intermediate risk and PJ with external stent (best cutoff 1000 IU/L, NPV 88.8%), and 0.574 for high risk and external stent (best cutoff 250 IU/L, NPV 93.7%). Independent predictors of POPF were body mass index, pancreatic texture, and early drain removal, whereas POD1 DFA was not. CONCLUSION: In the era of risk stratification and mitigation strategies, selective early drain removal still is associated with a reduced rate of POPF. However, a single protocol based on POD1-DFA is not suitable for all clinical scenarios after PD.

Pros and pitfalls of externalized trans-anastomotic stent as a mitigation strategy of POPF: a prospective risk-stratified observational series.

BACKGROUND: Several advantages and pitfalls have been related to externalized trans-anastomotic stents (ETS) after pancreaticoduodenectomy. The purpose of this study was to investigate the effect of an ETS effect in a risk-stratified setting. METHODS: Data from patients at either intermediate- or high-risk for postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy were prospectively analyzed from January 2016 to December 2019. Outcomes included POPF rate, mean complication burden (ACB), and complications related to ETS malfunction. RESULTS: A total of 540 patients met the inclusion criteria. Following an intention-to-treat analysis, there was no difference in terms of POPF and the ACB in the intermediate (22 vs.29%, p = 0.148; 0.38 vs.0.24, p = 0.082) and high-risk categories (58 vs.37%, p = 0.103; 0.33 vs.0.33, p = 0.478) comparing PJ to PJ-ETS. Excluding patients experiencing ETS malfunction (n = 45, 22%), ETS was associated with a significantly reduced ACB in the intermediate-risk (0.38 vs.0.26, p = 0.009) and POPF rate in the high-risk category (58 vs.32%, p = 0.033). In patients with ETS malfunction an increased rate of severe morbidity (Clavien-Dindo ≥ III, 33 vs.19%, p = 0.044) was observed as compared to patients with functioning ETS. CONCLUSION: ETS provides crucial advantages for prevention and mitigation of POPF depending on risk setting and its correct functioning. ETS malfunction is not uncommon and increases morbidity. Improving ETS design and fixing technique might lead to better outcomes.

Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial.

Importance: The operative scenarios with the highest postoperative pancreatic fistula (POPF) risk represent situations in which fistula prevention and mitigation strategies have the strongest potential to affect surgical outcomes after pancreaticoduodenectomy. Evidence from studies providing risk stratification is lacking. Objective: To investigate whether pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent, is the best reconstruction method for patients at high risk of POPF after pancreaticoduodenectomy. Design, Setting, and Participants: A single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score, some of whom were randomized to undergo PG or PJ. All analyses were performed on an intention-to-treat basis. Interventions: Intervention consisted of PJ or PG, both with externalized transanastomotic stent and octreotide omission. Main Outcomes and Measures: The primary end point was POPF. The secondary end points were Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden. Results: A total of 604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n = 36; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n = 36; 26 men and 10 women; median age, 63 years [interquartile range, 35-79]). There was no significant difference in the incidence of POPF between patients who underwent PG and patients who underwent PJ (18 [50.0%] vs 14 [38.9%]; P = .48), but for patients who developed a POPF, the mean (SD) average complication burden was lower for those who underwent PJ than for those who underwent PG (0.25 [0.13] vs 0.39 [0.17]; P = .04). The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047). Conclusions and Relevance: Among patients at the highest risk for POPF, those who underwent PG or PJ experienced similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo grade 3 or higher morbidity and with an increased average complication burden for the patients who developed a POPF. For patients at high risk for pancreatic fistula, PJ with the use of externalized stent and octreotide omission should be considered the most appropriate technical strategy. Trial Registration: ClinicalTrials.gov Identifier: NCT03212196.

Patterns of Recurrence after Resection for Pancreatic Neuroendocrine Tumors: Who, When, and Where?

BACKGROUND/AIMS: Pancreatic neuroendocrine tumors (pan-NENs) represent an increasingly common indication for pancreatic resection, but there are few data regarding possible recurrence after surgery. The aim of the study was to describe the frequency, timing, and patterns of recurrence after resection for pan-NENs with consequent implications for postoperative follow-up. METHODS: We performed a retrospective analysis of pan-NENs resected between 1990 and 2015 at The Pancreas Institute, University of Verona Hospital Trust. Predictors of recurrence were assessed. Survival analysis was conducted using the Kaplan-Meier and conditional survival (CS) methods. RESULTS: The cohort consisted of 487 patients with a median follow-up of 71 months. Recurrence developed in 12.3%: 54 (11.1%) liver metastases, 11 (2.3%) local recurrence, 10 (2.1%) nodal recurrence, and 8 (1.6%) metastases in other organs. Thirty-one (6.4%) died due to disease recurrence. Size > 21 mm, G3 grade, nodal metastasis, and vascular infiltration were independent predictors of overall recurrence. Recurrence occurred either during the first year of follow-up (n = 9), or after 10 years (n = 4). CS analysis revealed that nonfunctioning G1 pan-NEN ≤20 mm without nodal metastasis or vascular invasion had a negligible risk of developing recurrence. In the present series, after 5 years of follow-up without developing recurrence, tumor recurrence occurred only in the form of liver metastases. CONCLUSIONS: Recurrence of pan-NENs is rare and is predicted by tumor size, nodal metastasis, grading, and vascular invasion. Patients with G1 pan-NEN without nodal metastasis and vascular invasion may be considered cured by surgery. After 5 years without recurrence, follow-up should focus on excluding the development of liver metastases.

Clinical Implications of Intraoperative Fluid Therapy in Pancreatic Surgery.

BACKGROUND: Recent studies have suggested that intraoperative fluid overload is associated with a worse outcome after major abdominal surgery. However, evidence in the field of pancreatic surgery is still not consistent. The aim of this study was to evaluate whether intraoperative fluid management could affect the outcome of a major pancreatic resection. METHODS: Prospective analysis of 350 major pancreatic resections performed in 2016 at the Department of General and Pancreatic Surgery-The Pancreas Institute, University of Verona Hospital Trust. Patients were dichotomized according to intraoperative fluid volume administration (near-zero vs. liberal fluid balance) and matched using propensity score. Intraoperative fluid administration was then correlated to the postoperative outcome. RESULTS: Liberal fluid balance was associated with an increased rate of Clavien-Dindo ≥ IIIB both after pancreaticoduodenectomy (60.3 vs. 30.2%, p < 0.01) and distal pancreatectomy (50 vs. 27.1%, p = 0.03). In case of pancreaticoduodenectomy, liberal fluid balance was also associated with an increased rate of pancreatic fistula (33.3 vs. 19.9%, p = 0.05), but when considering patients with soft remnants, an increase rate of pancreatic fistula (52.8 vs. 23%, p = 0.03) was indeed associated with the near-zero fluid balance. CONCLUSION: Considering all pancreatic resections, a liberal fluid balance is associated with an increased rate of postoperative morbidity. However, in the case of PD with a soft pancreas, an NZF balance could lead to pancreatic stump ischemia and anastomotic failure. Intraoperative fluid management should be managed according to patient's pancreas-specific risk factors.

Postoperative Acute Pancreatitis Following Pancreaticoduodenectomy: A Determinant of Fistula Potentially Driven by the Intraoperative Fluid Management.

OBJECTIVE: The aim of the study is to characterize postoperative acute pancreatitis (POAP). SUMMARY BACKGROUND DATA: A standardized definition of POAP after pancreaticoduodenectomy (PD) has been recently proposed, but specific studies are lacking. METHODS: The patients were extracted from the prospective database of The Pancreas Institute of Verona. POAP was defined as an elevation of the serum pancreatic amylase levels above the upper limit of normal (52 U/L) on postoperative day (POD) 0 or 1. The endpoints included defining the incidence and predictors of POAP and investigating the association of POAP with postoperative pancreatic fistula (POPF). RESULTS: The study population consisted of 292 patients who underwent PD. The POAP and POPF rates were 55.8% and 22.3%, respectively. POAP was an independent predictor of POPF (OR 3.8), with a 92% sensitivity and 53.7% specificity (AUC 0.79). Preoperative exocrine insufficiency (OR 0.39), neoadjuvant therapy (OR 0.29) additional resection of the pancreatic stump margin (OR 0.25), soft pancreatic texture (OR 4.38), and Main Pancreatic Duct (MPD) diameter ≤3 mm (OR 2.86) were independent predictors of POAP. In high-risk patients, an intraoperative fluid administration of ≤3 ml/kg/h was associated with an increased incidence of POAP (24.6 vs. 0%, P = 0.04) and POPF (27.6 vs. 11.4%, P = 0.05). CONCLUSION: This study represents the first clinical application of the only available definition of POAP as a specific complication of pancreatic surgery. POAP is associated with an increased occurrence of POPF and overall morbidity and could potentially be avoided through a specific intraoperative fluid regimen in high-risk pancreas.