Protocolized care pathways in emergency general surgery: a systematic review and meta-analysis.

BACKGROUND: Emergency abdominal surgery is associated with significant postoperative morbidity and mortality. The delivery of standardized pathways in this setting may have the potential to transform clinical care and improve patient outcomes. METHODS: The OVID SP versions of MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched between January 1950 and October 2022. All randomized and non-randomized cohort studies comparing protocolized care streams with standard care protocols in adult patients (>18 years old) undergoing major emergency abdominal surgery with 30-day follow-up data were included. Studies were excluded if they reported on standardized care protocols in the trauma or elective setting. Outcomes assessed included length of stay, 30-day postoperative morbidity, 30-day postoperative mortality and 30-day readmission and reoperations rates. Risk of bias was assessed using ROBINS-I for non-randomized studies and RoB-2 for randomized controlled trials. Meta-analysis was performed using random effects modelling. RESULTS: Seventeen studies including 20 927 patients were identified, with 12 359 patients undergoing protocolized care pathways and 8568 patients undergoing standard care pathways. Thirteen unique protocolized pathways were identified, with a median of eight components (range 6-15), with compliance of 24-100%. Protocolized care pathways were associated with a shorter hospital stay compared to standard care pathways (mean difference -2.47, 95% c.i. -4.01 to -0.93, P = 0.002). Protocolized care pathways had no impact on postoperative mortality (OR 0.87, 95% c.i. 0.41 to 1.87, P = 0.72). A reduction in specific postoperative complications was observed, including postoperative pneumonia (OR 0.42 95% c.i. 0.24 to 0.73, P = 0.002) and surgical site infection (OR 0.34, 95% c.i. 0.21 to 0.55, P < 0.001). DISCUSSION: Protocolized care pathways in the emergency setting currently lack standardization, with variable components and low compliance; however, despite this they are associated with short-term clinical benefits.

Formation of a conceptual framework during the development of a patient-reported outcome measure for early gastrointestinal recovery: phase I of the PRO-diGi study.

AIM: Patients admitted to hospital for abdominal surgery often experience gastrointestinal dysfunction. Many studies have reported outcomes following gastrointestinal dysfunction, yet there is no unified definition of recovery or a validated patient-reported outcome measure (PROM). The first stage of PROM development requires formation of a conceptual framework to identify key themes to patients. The aim of this study was to utilize semistructured interviews to identify core themes and concepts relevant to patients to facilitate development of a conceptual framework. METHOD: Adult patients admitted to hospital for major gastrointestinal, urological or gynaecological surgery, in an emergency or elective setting, were eligible to participate. Patients treated nonoperatively for small bowel obstruction were also eligible. Interviews were conducted by telephone, audio-recorded, transcribed, coded and analysed using NVivo software by two researchers and reviewed by lay members of the steering group. Interviews continued until data saturation was reached. Ethical approval was gained prior to interviews (21/WA/0231). RESULTS: Twenty nine interviews were completed (17 men, median age 64 years) across three specialties (20 gastrointestinal, six gynaecological, three urological). Two overarching themes of 'general recovery' and 'gastrointestinal symptoms' were identified. General recovery included three themes: 'life impact', 'mental impact', including anxiety, and 'physical impact', including fatigue. Gastrointestinal symptoms included three themes: 'abdominal symptoms' such as pain, 'diet and appetite' and 'expulsory function', such as stool frequency. A total of 18 gastrointestinal symptoms were identified during patient recovery-many of which lasted several weeks following discharge. CONCLUSION: This study reports a range of gastrointestinal and nongastrointestinal symptoms experienced by patients during early gastrointestinal recovery. Identified symptoms have been synthesized into a conceptual framework to enable development of a definitive PROM for early gastrointestinal recovery.

Development and validation of a patient reported outcome measure for health-related quality of life for locally recurrent rectal cancer: a multicentre, three-phase, mixed-methods, cohort study.

Background: Locally recurrent rectal cancer (LRRC) occurs in 5-10% of patients following previous treatment of rectal cancer. It has a significant impact on patients' overall health-related quality of life (HrQoL). Major advances in surgical treatments have led to improved survival outcomes. However, due to the lack of disease-specific, validated patient-reported outcome measure (PROM), HrQoL, is variably assessed. The aim of this study is to develop a disease-specific, psychometrically robust, and validated PROM for use in LRRC. Methods: A multicentre, three phase, mixed-methods, observational study was performed across five centres in the UK and Australia. Adult patients (>18 years old) with an existing or previously treated LRRC within the last 2 years were eligible to participate. Patients completed the proposed LRRC-QoL, EORTC QLQ-CR29, and FACT-C questionnaires. Scale structure was analysed using multi-trait scaling analysis and exploratory factor analysis, reliability was assessed using Cronbach's and the intra-class coefficient, convergent validity was assessed using Pearson's correlation, and known-groups comparison was assessed using the student t-test or ANOVA. Findings: Between 01/03/2015 and 31/12/2019, 117 patients with a diagnosis of LRRC were recruited. The final scale structure of the LRRC-QoL consisted of nine multi-item scales (healthcare services, psychological impact, pain, urostomy-related symptoms, lower limb symptoms, stoma, sexual function, sexual interest, and urinary symptoms) and three single items. Cronbach's Alpha and Intraclass correlation values of >0.7 across the majority of scales supported overall reliability. Convergent validity was demonstrated between LRRC-QoL Pain Scale and FACT-C Physical Well Being scale (r = 0.528, p < 0.001), LRRC-QoL Psychological Impact scale with EORTC QLQ CR29 Body Image (r = 0.680, p < 0.001) and the FACT-C Emotional Well Being scale (r = 0.326, p < 0.001), and LRRC-QoL Urinary Symptoms scale with EORTC QLQ-CR29 Urinary Frequency scale (r = 0.310, p < 0.001). Known-groups validity was demonstrated for gender, disease location, treatment intent, and re-recurrent disease. Interpretation: The LRRC-QoL has demonstrated robust psychometric properties and can be used in clinical and academic practice. Funding: None.

Short-term outcomes of health-related quality of life in patients with locally recurrent rectal cancer: multicentre, international, cross-sectional cohort study.

BACKGROUND: Overall survival rates for locally recurrent rectal cancer (LRRC) continue to improve but the evidence concerning health-related quality of life (HrQoL) remains limited. The aim of this study was to describe the short-term HrQoL differences between patients undergoing surgical and palliative treatments for LRRC. METHODS: An international, cross-sectional, observational study was undertaken at five centres across the UK and Australia. HrQoL in LRRC patients was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 and functional assessment of cancer therapy - colorectal (FACT-C) questionnaires and subgroups (curative versus palliative) were compared. Secondary analyses included the comparison of HrQoL according to the margin status, location of disease and type of treatment. Scores were interpreted using minimal clinically important differences (MCID) and Cohen effect size (ES). RESULTS: Out of 350 eligible patients, a total of 95 patients participated, 74.0 (78.0 per cent) treated with curative intent and 21.0 (22.0 per cent) with palliative intent. Median time between LRRC diagnosis and HrQoL assessments was 4 months. Higher overall FACT-C scores denoting better HrQoL were observed in patients undergoing curative treatment, demonstrating a MCID with a mean difference of 18.5 (P < 0.001) and an ES of 0.6. Patients undergoing surgery had higher scores denoting a higher burden of symptoms for the EORTC CR29 domains of urinary frequency (P < 0.001, ES 0.3) and frequency of defaecation (P < 0.001, ES 0.4). Higher overall FACT-C scores were observed in patients who underwent an R0 resection versus an R1 resection (P = 0.051, ES 0.6). EORTC CR29 scores identified worse body image in patients with posterior/central disease (P = 0.021). Patients undergoing palliative chemoradiation reported worse HrQoL scores with a higher symptom burden on the frequency of defaecation scale compared with palliative chemotherapy (P = 0.041). CONCLUSION: Several differences in short-term HrQoL outcomes between patients undergoing curative and palliative treatment for LRRC were documented. Patients undergoing curative surgery reported better overall HrQoL and a higher burden of pelvic symptoms.

Utilising quality of life outcome trajectories to aid patient decision making in pelvic exenteration.

BACKGROUND: Shared decision-making in pelvic exenteration is a complex and detailed process, which must balance clinical, oncological and patient-reported outcomes (PROs), whilst addressing and valuing the patient priorities. Communicating patient-centred information on quality of life (QoL) and functional outcomes is an essential component of this. The aim of this systematic review was to understand the impact of pelvic exenteration on QoL PROs over a longitudinal period and to develop QoL trajectories to support decision-making in this context. METHODS: MEDLINE, Embase and Web of Science databases were searched between 1st January 2000 and 20th December 2021 Studies reporting on PROs, including QoL, in adults undergoing pelvic exenteration were included. Risk of bias was assessed using the ROBINS-I assessment tool. Data from studies reporting QoL using the same outcome measure at the same candidate timepoint were extracted and synthesised to develop a longitudinal QoL trajectory. RESULTS: Fourteen studies consisting of 1370 patients were included in this review. QoL trajectories were constructed in the domains of physical function, psychological function, role function, sexual function, body image and general and specific symptoms. Decision-making was only assessed by one study, with satisfaction with decision-making reported to be high. There is an initial decline in QoL scores in the domains of physical function, role function, sexual function, body image and general health and symptoms deteriorating during the first 3-6 months post-operatively. Psychological function is the only QoL domain that remains stable throughout the post-operative period. CONCLUSION: Mapping QoL trajectories provides a visual representation of post-operative progress, highlighting the enduring impact of pelvic exenteration on patients and can be used to inform pre-operative shared decision-making.

Closed incision negative pressure wound therapy is associated with reduced surgical site infection after emergency laparotomy: A propensity matched-cohort analysis.

BACKGROUND: Surgical site infection contributes to a significant proportion of postoperative morbidity in patients undergoing emergency laparotomy. Surgical site infections cause significant patient burden, increase duration of stay, and have economic implications. Closed incision negative pressure therapy has been shown to reduce surgical site infection rates in patients undergoing elective laparotomy; however, there is limited evidence for their use in the emergency setting. This study aims to compare rates of surgical site infection between patients receiving closed incision negative pressure therapy and standard surgical dressing after emergency laparotomy through a propensity matched analysis. METHODS: A registry-based, prospective cohort study was undertaken using data from the National Emergency Laparotomy Audit database at our center. The primary outcome measure was surgical site infection as defined by the Centers for Disease Control criteria. Secondary outcomes included 30-day postoperative morbidity and grade, duration of stay, 30-day mortality, and readmission rates. A propensity-score matching was performed in a 1:1 ratio to mitigate for selection bias. RESULTS: A total of 1,484 patients were identified from the National Emergency Laparotomy Audit data set, and propensity-score matching resulted in 2 equally matched cohorts with 237 patients in each arm. The rate of surgical site infection was significantly lower in the closed incision negative pressure therapy cohort (16.9% vs 33.8%, P < .001). There were no overall differences in 30-day morbidity, Clavien-Dindo grade, Comprehensive Complication Index severity, length of hospital stay, reoperation rates, and 30-day mortality between the 2 groups. CONCLUSIONS: Prophylactic closed incision negative pressure therapy in emergency laparotomy patients is associated with a reduction in surgical site infection rates.

A systematic analysis highlighting deficiencies in reported outcomes for patients with stage IV colorectal cancer undergoing palliative resection of the primary tumour.

BACKGROUND: Management of the primary tumour in the presence of unresectable metastatic colorectal cancer (mCRC) is controversial. The role of primary tumour resection (PTR) has been investigated by a number of retrospective cohort studies, with a number on going randomised controlled trials. The aim of this study was to identify the clinical and patient-reported outcomes currently reported in studies that evaluate the role of PTR in mCRC. METHODS: Literature searches were performed in MEDLINE (via OvidSP) (1966-June 2017), EMBASE (via OvidSP) and the Cochrane Library using terms related to colorectal cancer and primary tumour resection. All studies documenting outcomes following palliative PTR were included. Eligible articles were assessed using the Risk of Bias In Non-Randomised Studies of Intervention (ROBINS-I) tool. RESULTS: Of 11,209 studies screened, 59 non-randomised studies reporting outcomes on 331,157 patients were included. Patient characteristics regarding performance status and co-morbidity were recorded in 26 (44.1%) and 17 (28.8%) studies. The chemotherapy regime used was reported in 27 (45.8%) studies. The operative setting and the operative approach was reported in 42 (71%) and 14 (23.7%) studies. Post-operative mortality and morbidity were reported in 33 (55.9%) and 35 (59.3%) studies. Overall survival was reported in 49 (83.1%) studies, with 5 different definitions identified. Quality of life was only reported in 1 (1.7%) study. CONCLUSION: This study demonstrates significant heterogeneity in the selection and definition of outcomes reported following PTR in mCRC. There is significant heterogeneity with a significant under-reporting of important outcomes such as treatment related adverse events and patient reported outcomes.

The Outcomes and Patterns of Treatment Failure After Surgery for Locally Recurrent Rectal Cancer.

OBJECTIVE: To assess the outcomes and patterns of treatment failure of patients who underwent pelvic exenteration surgery for recurrent rectal cancer. BACKGROUND: Despite advances in the management of rectal cancer, local recurrence still occurs. For appropriately selected patients, pelvic exenteration surgery can achieve long-term disease control. METHODS: Prospectively maintained databases of 5 high volume institutions for pelvic exenteration surgery were reviewed and data combined. We assessed the combined endpoints of overall 5-year survival, cancer-specific 5-year mortality, local recurrence, and the development of metastatic disease. RESULTS: Five hundred thirty-three patients who had undergone surgery for locally recurrent rectal cancer were identified. Five-year cancer-specific survival for patients with a complete (R0) resection is 44%, which was achieved in 59% of patients. For those with R1 and R2 resections, the 5-year survival was 26% and 10%, respectively. Radical resection required sacrectomy in 170 patients (32%), and total cystectomy in 105 patients (20%). Treatment failure included local recurrence alone in 75 patients (14%) and systemic metastases with or without local recurrence in 226 patients (42%). Chemoradiotherapy before exenteration was associated with a significant (P < 0.05) improvement in overall 5-year cancer-specific survival for those patients with an R0 resection. Postoperative chemotherapy did not alter outcomes. CONCLUSIONS: R0 resection of the pelvic recurrence is the most significant factor affecting overall and disease-free survival. The surgery is complex and often highly morbid, and where possible patients should be given perioperative chemoradiotherapy. Further investigations are required to determine the role of adjuvant chemotherapy.

Systematic review of health-related quality of life issues in locally recurrent rectal cancer.

The standardization of surgical techniques supplemented with appropriate neoadjuvant chemoradiation has led to the decline in local recurrence rates of rectal cancer (LRRC) from 25-50% to 5-10%. The outcomes reported for surgical intervention in LRRC is encouraging, however, a number of controversies exist especially in the ultra-advanced and palliative setting. Incorporating health-related quality of life (HRQoL) outcomes in this field could supplement traditional clinical endpoints in assessing the effectiveness of surgical intervention in this cohort. This review aimed to identify the HRQOL themes that might be relevant to patients with LRRC. A systematic review was undertaken to identify all studies reporting HRQoL in LRRC. Each study was evaluated with regards to its design and statistical methodology. A meta-synthesis of qualitative and quantitative studies was undertaken to identify relevant HRQoL themes. A total of 14 studies were identified, with 501 patients, with 80% of patients undergoing surgery. HRQoL was the primary endpoint in eight studies. Eight themes were identified: physical, psychological and social impact, symptoms, financial and occupational impact, relationships with others, communication with healthcare professionals and sexual function. The impact on HRQoL is multifactorial and wide ranging, with a number of issues identified that are not included in current measures. These issues must be incorporated into the assessment of HRQoL in LRRC through the development of a validated, disease-specific tool.