Surgical Advance Care Planning: Initial Validation of Patient Portal Messages for a Multisite Randomized Controlled Trial

The Joint Commission Journal on Quality and Patient Safety · 2026-05-01

I CAN DO Surgical ACP (Improving Completion, Accuracy and Dissemination of Surgical Advanced Care Planning): a protocol for a multisite, single-blinded, pragmatic randomised controlled trial to improve ACP completion in older adults in the presurgical setting

BMJ Open · 2025-09-01 · 1 citations

INTRODUCTION: Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE's use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions. METHODS AND ANALYSIS: This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1(AArm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines. ETHICS AND DISSEMINATION: The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT06090552. PROTOCOL NUMBER: Advarra Pro 00070994. UNIVERSITY OF CALIFORNIA, SAN FRANCISCO IRB IRIS NUMBER: 23-38948.Protocol Date: 24 October 2024. PROTOCOL VERSION: 4.

Results of a phase II trial of short-course radiation and TASOX [trifluridine/tipiracil (TAS-102) plus oxaliplatin] chemotherapy in operable rectal cancer

ESMO Gastrointestinal Oncology · 2025-08-08

<h3>Background</h3> Trifluridine/tipiracil (FTD/TPI) is approved for metastatic colorectal cancer as monotherapy or in combination with bevacizumab, though dosing in combination with oxaliplatin has not yet been established. The objective of the phase II SHORT trial (NCT04417699) was to determine the efficacy of short-course radiation (SC RT) followed by 3 months of FTD/TPI + oxaliplatin (TASOX) as a condensed total neoadjuvant therapy (TNT) regimen for intermediate-risk rectal cancer. <h3>Methods</h3> Eligible patients with clinical T3N0 or T1-3N1 nonlow rectal tumors and negative radial tumor margins (>1 mm) were enrolled. The primary endpoint was reduction in neoadjuvant response (NAR) score compared with historic controls. Patients received 25 Gy in five 5 Gy fractions of conformal pelvic radiation followed by six planned 14-day cycles of TASOX: FTD/TPI (35 mg/m²/dose) orally b.i.d. day 1-5, oxaliplatin 85 mg/m² i.v. day 1. Surgery was recommended within 4 weeks after cycle 6 of TASOX. <h3>Results</h3> Between 2020 and 2023, 13 patients with stage II (<i>n</i> = 5) and III (<i>n</i> = 8) rectal adenocarcinoma were enrolled at three institutions. Dose delivered was 100% of planned radiation, 99% of planned FTD/TPI and 95% oxaliplatin. Diarrhea was documented with a frequency of 11%, and was grade 1 only. Only 9% (8/87) of adverse events were grade 3/4, predominantly related to neutropenia. Among 10 patients who proceeded to total mesorectal excision surgery, 2 experienced a pathological complete response and 2 had a complete clinical response, of which 1 had no evidence of regrowth on continued watch and wait. <h3>Conclusions</h3> SC RT and 3 months of TASOX can be safely delivered to patients with intermediate-risk rectal cancer, offering a convenient regimen that should be further explored for rectal cancer treatment. The TASOX regimen may be of particular relevance for patients with suspected dihydropyrimidine dehydrogenase deficiency who require oxaliplatin-based therapy.

Risk Factors of Reoperation in Patients with Intestinal Behçet’s Disease Treated by Initial Bowel Resection

Journal of Clinical Medicine · 2024-11-11 · 2 citations

Background/Objectives: Intestinal Behçet’s disease (iBD) often requires surgical intervention, with a significant proportion of patients needing reoperation. This study aimed to investigate the risk factors associated with reoperation in patients with iBD who underwent initial bowel resection and to evaluate the perioperative and long-term outcomes in these patients. Methods: This was a retrospective case-control study analyzing patients who underwent their initial bowel resection due to iBD between 2005–2021 at a tertiary referral hospital. Reoperation was considered a surgery due to postoperative complications (within 30 days of the initial surgery) or disease progression. Results: A total of 81 patients were included. The median follow-up duration was 107.1 months, during which 26 patients (32%) underwent reoperation. Multivariable analysis showed that the presence of hematological disorders (hazards ratio [HR], 9.13; 95% confidence interval [CI], 3.79–22.02, p &lt; 0.001), higher c-reactive protein (CRP) levels before the initial surgery (HR, 1.01; 95% CI, 1.01–1.02, p &lt; 0.001), and a shorter specimen resection length (HR, 0.96; 95% CI, 0.93–0.99, p = 0.011) were risk factors for reoperation. Patients who underwent reoperation had higher rates of postoperative complications (69.2% vs. 43.6%, p = 0.031), required longer antibiotic use (12 vs. 7 days, p = 0.012), and had extended hospital stays (18 vs. 9 days, p = 0.011). They also had worse 5-year survival rates than those who did not undergo reoperation (83.5% vs. 98.4%, p = 0.012). Conclusions: Concurrent hematological disorders, high preoperative CRP levels, and short specimen resection were associated with an increased risk of reoperation in patients with iBD who underwent their initial bowel resections. They also had worse perioperative and long-term outcomes.

Baseline MRI predictors of successful organ preservation in the Organ Preservation in Rectal Adenocarcinoma (OPRA) trial

British journal of surgery · 2024-08-30 · 8 citations

BACKGROUND: Prospective randomized trials have not yet identified baseline features predictive of organ preservation in locally advanced rectal cancers treated with total neoadjuvant therapy and a selective watch-and-wait strategy. METHODS: This was a secondary analysis of the OPRA trial, which randomized patients with stage II-III rectal adenocarcinoma to receive either induction or consolidation total neoadjuvant therapy. Patients were recommended for total mesorectal excision, or watch and wait based on clinical response at 8 ± 4 weeks after completing treatment. Standardized baseline clinical and radiological variables were collected prospectively. Survival outcomes, including total mesorectal excision-free survival, disease-free survival, and overall survival, were assessed by intention-to-treat analysis. Cox proportional hazards models were used to evaluate associations between baseline variables and survival outcomes. RESULTS: Of the 324 patients randomized for the OPRA trial, 38 (11.7%) had cT4 tumours, 230 (71.0%) cN-positive disease, 101 (32.5%) mesorectal fascia involvement, and 64 (19.8%) extramural venous invasion. Several baseline features were independently associated with recommendation for total mesorectal excision on multivariable analysis: nodal disease (HR 1.66, 95% c.i. 1.12 to 2.48), extramural venous invasion (HR 1.57, 1.07 to 2.29), mesorectal fascia involvement (HR 1.45, 1.01 to 2.09), and tumour length (HR 1.11, 1.00 to 1.22). Of these, nodal disease (HR 2.02, 1.15 to 3.53) and mesorectal fascia involvement (HR 2.02, 1.26 to 3.26) also predicted worse disease-free survival. Age (HR 1.03, 1.00 to 1.06) was associated with overall survival. CONCLUSION: Baseline MRI features, including nodal disease, extramural venous invasion, mesorectal fascia involvement, and tumour length, independently predict the likelihood of organ preservation after completion of total neoadjuvant therapy. Mesorectal fascia involvement and nodal disease are associated with disease-free survival.

Effect of Specimen Extraction Site on Postoperative Incisional Hernia after Minimally Invasive Right Colectomy

Journal of the American College of Surgeons · 2024-02-28 · 4 citations

BACKGROUND: Incisional hernia (IH) is a known complication after colorectal surgery. Despite advances in minimally invasive surgery, colorectal surgery still requires extraction sites for specimen retrieval, increasing the likelihood of postoperative IH development. The objective of this study is to determine the effect of specimen extraction site on the rate of IH after minimally invasive right-sided colectomy for patients with available imaging. STUDY DESIGN: This is a retrospective multi-institutional cohort study at 2 large academic medical centers in the US. Adults who underwent right-sided minimally invasive colectomy from 2012 to 2020 with abdominal imaging available at least 1 year postoperatively were included in the analysis. The primary exposure was specimen extraction via a midline specimen extraction vs Pfannenstiel specimen extraction. The main outcome was the development of IH at least 1 year postoperatively as visualized on a CT scan. RESULTS: Of the 341 patients sampled, 194 (57%) had midline specimen extraction and 147 (43%) had a Pfannenstiel specimen extraction. Midline extraction patients were older (66 ± 15 vs 58 ± 16; p < 0.001) and had a higher rate of previous abdominal operation (99, 51% vs 55, 37%, p = 0.01). The rate of IH was higher in midline extraction at 25% (48) compared with Pfannenstiel extraction (0, 0%; p < 0.001). The average length of stay was higher in the midline extraction group at 5.1 ± 2.5 compared with 3.4 ± 3.1 days in the Pfannenstiel extraction group (p < 0.001). Midline extraction was associated with IH development (odds ratio 24.6; 95% CI 1.89 to 319.44; p = 0.004). Extracorporeal anastomosis was associated with a higher IH rate (odds ratio 25.8; 95% CI 2.10 to 325.71; p = 0.002). CONCLUSIONS: Patients who undergo Pfannenstiel specimen extraction have a lower risk of IH development compared with those who undergo midline specimen extraction.

Outcomes of Colectomy and Proctectomy According to Surgeon Training: General vs Colorectal Surgeons

Journal of the American College of Surgeons · 2024-03-13 · 7 citations

BACKGROUND: Colectomies and proctectomies are commonly performed by both general surgeons (GS) and colorectal surgeons (CRS). The aim of our study was to examine the outcomes of elective colectomy, urgent colectomy, and elective proctectomy according to surgeon training. STUDY DESIGN: Data were obtained from the Vizient database for adults who underwent elective colectomy, urgent colectomy, and elective proctectomy from 2020 to 2022. Operations performed in the setting of trauma and patients within the database's highest relative expected mortality risk group were excluded. Outcomes were compared according to surgeon's specialty: GS vs CRS. The primary outcome was in-hospital mortality. The secondary outcome was in-hospital complication rate. Data were analyzed using multivariate logistic regression. RESULTS: Of 149,516 elective colectomies, 75,711 (50.6%) were performed by GS and 73,805 (49.4%) by CRS. Compared with elective colectomies performed by CRS, elective colectomies performed by GS had higher rates of complications (4.9% vs 3.9%, odds ratio [OR] 1.23, 95% CI 1.17 to 1.29, p < 0.01) and mortality (0.5% vs 0.2%, OR 2.06, 95% CI 1.72 to 2.47, p < 0.01). Of 71,718 urgent colectomies, 54,680 (76.2%) were performed by GS, whereas 17,038 (23.8%) were performed by CRS. Compared with urgent colectomies performed by CRS, urgent colectomies performed by GS were associated with higher rates of complications (12.1% vs 10.4%, OR 1.14, 95% CI 1.08 to 1.20, p < 0.01) and mortality (5.1% vs 2.3%, OR 2.08, 95% CI 1.93 to 2.23, p < 0.01). Of 43,749 elective proctectomies, 28,458 (65.0%) were performed by CRS and 15,291 (35.0%) by GS. Compared with proctectomies performed by CRS, those performed by GS were associated with higher rates of complications (5.3% vs 4.4%, OR 1.16, 95% CI 1.06 to 1.27, p < 0.01) and mortality (0.3% vs 0.2%, OR 1.49, 95% CI 1.02 to 2.20, p = 0.04). CONCLUSIONS: In this nationwide study, colectomies and proctectomies performed by CRS were associated with improved outcomes compared with GS. Hospitals without a CRS on staff should consider prioritizing recruiting CRS specialists.

MRI Predicts Residual Disease and Outcomes in Watch-and-Wait Patients with Rectal Cancer

Radiology · 2024-09-01 · 18 citations

Restaging MRI can stratify patients treated with total neoadjuvant therapy into clinical response categories predictive of organ preservation, local regrowth, and survival.

SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Intervention in Survivors of Rectal Cancer

Cancer · 2024-02-22 · 3 citations

BACKGROUND: Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. METHODS: Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N = 47) or the Healthy Living Education attention control group (N = 46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26 weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. RESULTS: Most participants were White and college educated, with a mean age of 55.2 years and median time since surgery of 13.1 months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p = .01) and the frequency subscale of the bowel function index (p = .03). The AIMS-RC group reported significantly higher acceptability of the study. CONCLUSIONS: SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.

Clinical Significance of Prognostic Nutrition Index in Patients with Crohn’s Disease after Primary Bowel Resection

Yonsei Medical Journal · 2024-01-01 · 7 citations

PURPOSE: Although advancements in medical treatments have been made, approximately half of patients with intestinal Crohn's disease (CD) require intestinal resections during their lifetime. It is well-known that the nutritional status of CD patients can impact postoperative morbidity. The objective of this study was to evaluate the clinical significance of prognostic nutritional index (PNI) in patients with intestinal CD who underwent primary bowel resection. MATERIALS AND METHODS: We retrospectively investigated patients who were diagnosed with CD and underwent intestinal surgery at Severance Hospital between January 2005 and October 2018. The patients were divided into two groups: PNI ≤40 (n=150) and PNI >40 (n=77). We assessed the clinical significance of PNI in terms of the incidence of postoperative infectious complications (PICs) and the postoperative recurrence of CD. RESULTS: =0.034). CONCLUSION: Preoperative PNI could serve as a predictive factor for PICs in CD patients who undergo intestinal resection. Additionally, PICs are significantly associated with a higher risk of surgical recurrence in CD.