Project description:BackgroundMalignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction.MethodsS1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450.FindingsFrom May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group).InterpretationIn our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction.FundingAgency for Healthcare Research and Quality and the National Cancer Institute.TranslationFor the Spanish translation of the abstract see Supplementary Materials section.
Project description:Purpose:Malignant bowel obstruction (MBO) is a common problem in late-stage cancer patients. Many factors are suggested to be associated with the prognosis of MBO. The current investigation was designed to explore the factors associated with the prognosis of conservative and surgery treatment in one single institution. Patients and Methods:Sixty-four patients of MBO were recruited into the study. Demographic and clinical data including gender, age, primary cancer, radiological and laboratory examinations, and nutritional and pain index scaling were extracted for further analysis. Kaplan-Meier analysis and logistic regression analysis were used to compare the prognosis and detect significant factors. Results:Of the 64 patients, there is no statistical difference in baseline features between conservative and surgical group. However, the length of stay, total medical costs, re-admission interval, and re-admission rate are statistically significant. There is no significance in Kaplan-Meier log rank test for median survival time, though the overall survival time in the conservative group is longer than that of the surgery group. Logistic regression analysis has found that prior chemotherapy is a significant predictor for final survival outcome. Conclusion:The election of surgery might not improve the overall survival time. Non-surgical procedures, especially chemotherapy, might be preferable for MBO patients.
Project description:BackgroundMalignant bowel obstruction (MBO) is often a terminal event in end-stage cancer patients. The decision to intervene surgically is complex, given the risk of harm in patients with a limited lifespan. Therefore, we sought to compare clinically meaningful outcomes in MBO patients treated with surgical versus medical management using population-based data.MethodsWe performed a retrospective analysis of hospitalized patients with MBO from 2006 to 2010 using the California Office of Statewide Health Planning and Development dataset. Hospital-free days (HFDs) at 30-, 90-, and 180-days were calculated accounting for all hospitalization, emergency department visit, and skilled nursing facility lengths of stay. Adjusted regression models were used to compare HFDs, disposition, complications, in-hospital death, and survival for surgical versus medical MBO cohorts, using inverse probability of treatment weighting with propensity scores.ResultsOf 4576 MBO patients, 3421 (74.8%) were treated medically and 1155 (25.2%) were treated surgically. Surgical patients had higher rates of complications (44.0% vs. 21.3%, p < 0.0001) and in-hospital death (9.5% vs. 3.9%, p < 0.0001) with lower rates of disposition to home (76.3% vs. 89.8%, p < 0.0001). Surgical patients had fewer 30- and 90-day HFDs compared to medical patients (p < 0.01). However, at 180-days, there were no differences in HFDs between treatment groups. There was no difference in overall survival between surgical and medical patients (median 6.5 vs. 6.4 months).ConclusionIn this population-based analysis, medical management was associated with less hospital utilization at 30- and 90-days, fewer in-hospital deaths, and more frequent discharges to home. These data underscore the potential benefits of medical management for MBO patients at the end-of-life.
Project description:BackgroundSmall bowel obstruction (SBO) is characterized by a high rate of recurrence. In the present study, we aimed to compare the outcomes of patients managed either by conservative treatment or surgical operation for an episode of SBO.MethodsThe outcomes of all patients hospitalized at a single center for acute SBO between 2004 and 2007 were assessed. The occurrence of recurrent hospitalization, surgery, SBO symptoms at home, and mortality was determined.ResultsAmong 221 patients admitted with SBO, 136 underwent a surgical procedure (surgical group) and 85 were managed conservatively (conservative group). Baseline characteristics were similar between treatment groups. The median follow-up time (interquartile range) was 4.7 (3.7-5.8) years. Nineteen patients (14.0 %) of the surgical group were hospitalized for recurrent SBO versus 25 (29.4 %) of the conservative group [hazard ratio (HR), 0.5; 95 % CI, 0.3-0.9]. The need for a surgical management of a new SBO episode was similar between the two groups, ten patients (7.4 %) in the surgical group and six patients (7.1 %) in the conservative group (HR, 1.1; 95 % CI, 0.4-3.1). Five-year mortality from the date of hospital discharge was not significantly different between the two groups (age- and sex-adjusted HR, 1.1; 95 % CI, 0.6-2.1). A follow-up evaluation was obtained for 130 patients. Among them, 24 patients (34.8 %) of the surgical group and 35 patients (57.4 %) of the conservative group had recurrent SBO symptoms (odds ratio, 0.4; 95 % CI, 0.2-0.8).ConclusionsThe recurrence of SBO symptoms and new hospitalizations were significantly lower after surgical management of SBO compared with conservative treatment.
Project description:BackgroundAlthough stent placement is increasingly performed, colostomy still is considered the gold standard for emergent relief of malignant colonic obstruction (MCO). This study aimed to compare hospital costs and clinical outcomes between patients undergoing colostomy and those undergoing stenting for the management of MCO.MethodsA retrospective claims analysis of the Medicare Provider Analysis and Review (MedPAR) data set was conducted to identify inpatient hospitalizations for colostomy or stent placement for the treatment of colon cancer (2007-2008). The outcomes evaluated using MedPAR compared the total length of hospital stay (LOS) and the costs associated with both techniques. Because MedPAR is a claims data set that does not provide outcomes at a patient level, a single-institution retrospective case-control study was conducted in which each stent placement patient was matched with two colostomy patients during the same period. Outcome measures (institutional data) were used to compare rates of treatment success, postprocedure LOS, and reinterventions between the two cohorts.ResultsThe MedPAR data evaluated 778 stent placements and 5,868 colostomy hospitalizations. There were no differences in gender, age distribution, or comorbidity between the two groups. Compared with colostomy, the median LOS (8 vs. 12 days; p<0.0001) and the median cost ($15,071 vs. $24,695; p<0.001) per claim were significantly less for stent placement. Stent placement was more commonly performed at urban versus rural hospitals (84% vs. 16%; p<0.0001), teaching versus nonteaching hospitals (56% vs. 44%; p=0.0058) and larger versus smaller institutions (mean bed capacity, 331 vs. 227; p<0.0001). The institution data included 12 patients who underwent stent placement and 24 who underwent colostomy. Although both methods were technically successful, the median postprocedure LOS (2.17 vs. 10.58 days; p=0.0004) and the rate of readmissions for complications (0% vs. 25%; p=0.01) were significantly lower for stent placement.ConclusionAlthough the technical and clinical outcomes for colostomy and stent placement appear comparable, stent placement is less costly and associated with shorter LOS and fewer complications. Dissemination of stent placement beyond large teaching hospitals located in urban areas as a treatment for MCO is important given its implications for patient care and resource use.
Project description:ObjectiveTo describe rates of dexamethasone use in the nonoperative management of malignant small bowel obstruction (mSBO) and their outcomes.BackgroundmSBO is common in patients with advanced abdominal-pelvic cancers. Management includes prioritizing quality of life and avoiding surgical intervention when possible. The use of dexamethasone to restore bowel function is recommended in the National Comprehensive Cancer Network guidelines for mSBO. Yet, it is unknown how often dexamethasone is used for mSBO and whether results from nonresearch settings support its use.MethodsThis is a multicenter retrospective cohort study including unique admissions for mSBO from January 1, 2019 to December 31, 2021. Dexamethasone use and management outcomes were summarized with descriptive statistics and multiple logistic regression.ResultsAmong 571 admissions (68% female, mean age 63 years, 85% history of abdominal surgery) that were eligible and initially nonoperative, 26% [95% confidence interval (CI) = 23%-30%] received dexamethasone treatment (69% female, mean age 62 years, 87% history of abdominal surgery). Dexamethasone use by site ranged from 13% to 52%. Among dexamethasone recipients, 13% (95% CI = 9%-20%) subsequently required nonelective surgery during the same admission and 4 dexamethasone-related safety-events were reported. Amongst 421 eligible admissions where dexamethasone was not used, 17% (95% CI = 14%-21%) required nonelective surgery. Overall, the unadjusted odds ratio (OR) for nonelective surgery with dexamethasone use compared to without its use was 0.7 (95% CI = 0.4-1.3). Using multiple logistic regression, OR after adjusting for site, age, sex, history of abdominal surgery, nasogastric tube, and Gastrografin use was 0.6 (95% CI = 0.3-1.1).ConclusionDexamethasone was used in about 1 in 4 eligible mSBO admissions with high variability of use between tertiary academic centers. This multicenter retrospective cohort study suggested an association between dexamethasone use and lower rates of nonelective surgery, representing a potential opportunity for quality improvement.
Project description:PurposeTo provide evidence-based recommendations on the management of malignant bowel obstruction (MBO) for patients with advanced cancer.MethodsThe Multinational Association for Supportive Care in Cancer (MASCC) MBO study group conducted a systematic review of databases (inception to March 2021) to identify studies about patients with advanced cancer and MBO that reported on the following outcomes: symptom management, bowel obstruction resolution, prognosis, overall survival, and quality of life. The review was restricted to studies published in English, but no restrictions were placed on publication year, country, and study type. As per the MASCC Guidelines Policy, the findings were synthesized to determine the levels of evidence to support each MBO intervention and, ultimately, the graded recommendations and suggestions.ResultsThe systematic review identified 17,656 published studies and 397 selected for the guidelines. The MASCC study group developed a total of 25 evidence-based suggestions and recommendations about the management of MBO-related nausea and vomiting, bowel movements, pain, inflammation, bowel decompression, and nutrition. Expert consensus-based guidance about advanced care planning and psychosocial support is also provided.ConclusionThis MASCC Guideline provides comprehensive, evidence-based recommendations about MBO management for patients with advanced cancer.
Project description:BackgroundMalignant bowel obstruction (MBO) is a serious clinical entity that requires surgical intervention in almost 50% of cases. However, overall survival remains low even for operable cases. The aim of the present study was to investigate the correlation between patients' characteristics, perioperative details, histopathological results and postoperative outcomes of patients who were operated on due to MBO.MethodsA retrospective search of patients who were operated on due to MBO in a university and a rural hospital was conducted. Patients' characteristics, perioperative details, histopathological results and postoperative outcomes were reported. Univariable and multivariable analysis was performed.ResultsSeventy patients were included with a mean age of 76.1 ± 10.6 years. The 30-day mortality rate was 18.6%, the Intensive Care Unit (ICU) admission rate was 17.1% and the mean length of stay (LOS) was 12.4 ± 5.7 days. Postoperative 30-day mortality was associated with increased age, known malignant recurrence, microscopically visible metastatic foci and defunctioning stoma creation. Colorectal malignancy type, sigmoid obstruction and primary anastomosis were correlated with decreased 30-day mortality. In addition, operation at the university hospital led to increased LOS, while stoma creation led to decreased LOS. Finally, ICU admission rates were increased for operations at university hospitals, at least one comorbidity, known malignant recurrence and longer preoperative waiting interval, whereas they were decreased for colorectal primary malignancy type.ConclusionsSurgery due to MBO leads to increased morbidity and mortality. Therefore, prospective studies are needed to highlight inter-patient differences regarding the best individualized therapeutic strategy.
Project description:BACKGROUND:For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown. METHODS:We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24?months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. RESULTS:A total of 203 adults were randomly assigned to septoplasty (N?=?102) or non-surgical management (N?=?101). After 12?months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI -?0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24?months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI -?0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. CONCLUSIONS:Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24?months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24?months, but it comes closer to the cost-effectiveness threshold as time passes by. TRIAL REGISTRATION:Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.