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PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study.

ABSTRACT: INTRODUCTION:Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease. METHODS AND ANALYSIS:A prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6?months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6?months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2?years. ETHICS AND DISSEMINATION:The protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open, Annals of Surgery, British Journal of Surgery, Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER:The study is registered with the ClinicalTrials.gov register as NCT03527706; Pre-results.

SUBMITTER: Sohn M

PROVIDER: S-EPMC7202696 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study.

Sohn Maximilian M Agha Ayman A Iesalnieks Igors I Bremer Susanne S Trum Stefanie S Di Cerbo Francesca F Nerlich Andreas A Lotz Natalie N Klieser Eckhard E Hochrein Alfred A Schredl Philipp P Kalcheva Dariya D Emmanuel Klaus K Presl Jaroslav J

BMJ open 20200324 3

<h4>Introduction</h4>Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a cha ...[more]

PMID: 32209628

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Project description:To this day, the treatment of generalized peritonitis secondary to diverticular perforation is still controversial. Recently, in patients with acute sigmoid diverticulitis, laparoscopic lavage and drainage has gained a wide interest as an alternative to resection. Based on this backdrop, we decided to perform a systematic review of the literature to evaluate the safety, feasibility, and efficacy of peritoneal lavage in perforated diverticular disease.A bibliographic search was performed in PubMed for case series and comparative studies published between January 1992 and February 2014 describing laparoscopic peritoneal lavage in patients with perforated diverticulitis.A total of 19 articles consisting of 10 cohort studies, 8 case series, and 1 controlled clinical trial met the inclusion criteria and were reviewed. In total these studies analyzed data from 871 patients. The mean follow-up time ranged from 1.5 to 96 months when reported. In 11 studies, the success rate of laparoscopic peritoneal lavage, defined as patients alive without surgical treatment for a recurrent episode of diverticulitis, was 24.3%. In patients with Hinchey stage III diverticulitis, the incidence of laparotomy conversion was 1%, whereas in patients with stage IV it was 45%. The 30-day postoperative mortality rate was 2.9%. The 30-day postoperative reintervention rate was 4.9%, whereas 2% of patients required a percutaneous drainage. Readmission rate after the first hospitalization for recurrent diverticulitis was 6%. Most patients who were readmitted (69%) required redo surgery. A 2-stage laparoscopic intervention was performed in 18.3% of patients.Laparoscopic peritoneal lavage should be considered an effective and safe option for the treatment of patients with sigmoid diverticulitis with Hinchey stage III peritonitis; it can also be consider as a "bridge" surgical step combined with a delayed and elective laparoscopic sigmoidectomy in order to avoid a Hartmann procedure. This minimally invasive staged approach should be considered for patients without systemic toxicity and in centers experienced in minimally invasive surgery techniques. Further evidence is needed, and the ongoing RCTs will better define the role of the laparoscopic peritoneal lavage/drainage in the treatment of patients with complicated diverticulitis.

Project description:OBJECTIVES:To evaluate cervical regeneration at 6?months following excisional treatment for high-grade cervical intraepithelial neoplasia (CIN), and to investigate the effect of cone dimensions, age of patients and technique of excision on the efficacy of the regeneration process. DESIGN:Prospective observational multicentric study. SETTING:Three tertiary care and research centres. PARTICIPANTS:Among the 197 eligible women of childbearing age, older than 25 years of age, undergoing for the first time a loop electrosurgical excision procedure or carbon dioxide laser cervical excision for a high-grade CIN at the colposcopy-directed cervical punch biopsy, and with a final diagnosis of high-grade CIN, 165 completed the 6-month follow-up and were included in the analysis. PRIMARY OUTCOME MEASURES:The cervical length and volume regeneration (%) after 6?months from procedure were determined by three-dimensional ultrasound, and the correlation of regeneration with cone dimensions, age and excision technique was evaluated. RESULTS:The mean±SD?cervical length regeneration at 6?months was 89.5%±6.3%?and the mean±SD?cervical volume regeneration was 86.3%±13.2%. At the multivariate analysis, a significant and independent inverse correlation between excised cone length and cervical regeneration emerged (r=-0.39, P<0.001). A significantly negative trend in length regeneration at 6?months from procedure with an increasing class of cone length was found (P<0.001). No significant association was found in relation with patient age at the time of procedure or with the technique of excision. CONCLUSIONS:Cervical length regeneration at 6?months from excisional treatments is negatively affected by an increasing cone length but not from the age of the patient or the technique of excision. While still achieving equal clinical efficacy, it is crucial to contain cone dimensions, in order to favour a greater length regeneration, reducing the cervical harm and the potential future obstetric complications.

Project description:BackgroundNon-occlusive mesenteric ischemia (NOMI) is a challenging diagnosis and is associated with extremely high mortality in critically ill patients, particularly due to delayed diagnosis and when complicated by intestinal necrosis. Plasma citrulline and intestinal-fatty acid binding protein (I-FABP) have been proposed as potential biomarkers, but have never been studied prospectively in this setting. We aimed to investigate diagnostic features, the accuracy of plasma citrulline and I-FABP to diagnose NOMI and intestinal necrosis as well as prognosis.MethodsWe conducted a prospective observational study in 3 tertiary ICU centers in consecutive patients with NOMI suspicion defined by at least two inclusion criteria among: new-onset or worsening circulatory failure, gastrointestinal dysfunction, biological signs and CT-scan signs of mesenteric ischemia. Diagnosis features and outcomes were compared according to NOMI, intestinal necrosis or ruled out diagnosis using stringent classification criteria.ResultsDiagnosis of NOMI was suspected in 61 patients and confirmed for 33 patients, with intestinal necrosis occurring in 27 patients. Clinical digestive signs, routine laboratory results and CT signs of mesenteric ischemia did not discriminate intestinal necrosis from ischemia without necrosis. Plasma I-FABP was significantly increased in presence of intestinal necrosis (AUC 0.83 [0.70-0.96]). A threshold of 3114 pg/mL showed a sensitivity of 70% [50-86], specificity of 85% [55-98], a negative predictive value of 58% [36-93] and a positive predictive value 90% [67-96] for intestinal necrosis diagnosis. When intestinal necrosis was present, surgical resection was significantly associated with ICU survival (38.5%), whereas no patient survived without necrosis resection (HR = 0.31 [0.12-0.75], p = 0.01).ConclusionIn critically ill patients with NOMI, intestinal necrosis was associated with extremely high mortality, and increased survival when necrosis resection was performed. Elevated plasma I-FABP was associated with the diagnosis of intestinal necrosis. Further studies are needed to investigate plasma I-FABP and citrulline performance in less severe forms of NOMI.

Project description:BackgroundRecent genetic studies identified common mutations between diverticular disease and connective tissue disorders, some of which are associated with abdominal wall hernias. Scarce data exists, however, shedding light on the potential clinical implications of this shared etiology, particularly in the era of laparoscopic surgery.MethodsThe New York Statewide Planning and Research Cooperative System database was used to identify adult patients undergoing elective sigmoid and left hemicolectomy (open or laparoscopic) from January 1, 2010, to December 31, 2016, for diverticulitis or descending/sigmoid colon cancer. The incidences of incisional hernia diagnosis and repair were compared using competing risks regression models, clustered by surgeon and adjusted for a host of demographic/clinical variables. Subsequent abdominal surgery and death were considered competing risks.ResultsAmong 8279 patients included in the study cohort, 6811 (82.2%) underwent colectomy for diverticulitis and 1468 (17.8%) for colon cancer. The overall 5-year risk of incisional hernia was 3.5% among patients with colon cancer, regardless of colectomy route, which was significantly lower than that among diverticulitis patients after both open (10.7%; p < 0.001) and laparoscopic (7.2%; p = 0.007) colectomies. Multivariable analyses demonstrated that patients with diverticulitis experienced a two-fold increase in the risk for hernia diagnosis (aHR 1.8; p < 0.001) and repair (aHR 2.1; p < 0.001), and these findings persisted after stratification by colectomy route.ConclusionsPatients undergoing elective colectomy for diverticulitis, including via laparoscopic approach, experience higher rates of incisional hernia compared with patients undergoing similar resections for colon cancer. When performing resections for diverticulitis, surgeons should strongly consider adherence to evidence-based guidelines for fascial closure to prevent this important complication.

Project description:BackgroundCurrent principles of postoperative pain management are primarily based on the types and extent of surgical intervention. This clinical study measured patient's self-anticipated pain score before surgery, and compared the anticipated scores with the actual pain levels and analgesic requirements after surgery.MethodsThis prospective observational study recruited consecutive patients who received elective surgery in the E-Da Hospital, Taiwan from June to August 2018. Patients were asked to subjectively rate their highest anticipated pain level (numeric rating scale, NRS 0-10) for the scheduled surgical interventions during their preoperative anesthesia assessment. After the operation, the actual pain intensity (NRS 0-10) experienced by the patient in the post-anesthesia care unit and the total dose of opioids administered during the perioperative period were recorded. Pain scores ≥4 on NRS were regarded as being unacceptable levels for anticipated or postoperative pain that required more aggressive intervention.ResultsA total of 996 patients were included in the study. Most of the patients (86%) received general anesthesia and 73.9% of them had a history of previous operation. Female anticipated significantly higher overall pain intensities than the male patients (adjusted odd ratio 1.523, 95% confidence interval 1.126-2.061; P = 0.006). Patients who took regular benzodiazepine at bedtime (P = 0.037) and those scheduled to receive more invasive surgical procedures were most likely to anticipate for higher pain intensity at the preoperative period (P < 0.05). Higher anticipated pain scores (preoperative NRS ≥ 4) were associated with higher actual postoperative pain levels (P = 0.007) in the PACU and higher total equivalent opioid use (P < 0.001) for acute pain management during the perioperative period.ConclusionThis observational study found that patients who are female, use regular benzodiazepines at bedtime and scheduled for more invasive surgeries anticipate significantly higher surgery-related pain. Therefore, appropriate preoperative counseling for analgesic control and the management of exaggerated pain expectation in these patients is necessary to improve the quality of anesthesia delivered and patient's satisfaction.

Project description:BackgroundNon-technical skills (NTS) are important for the proper functioning of emergency medical ambulance crews but have hardly been researched in the conditions of clinical pre-hospital care. The primary objective of this study, therefore, is to describe the use of NTS in practice. The secondary objective is to compare if the performance of NTS varies according to the type of case.MethodsIn this multicentric observational study the modified Team Emergency Assessment Measure (TEAM) score was used to assess the performed NTS of two or more crews on site. The evaluation consisted of leadership, teamwork and task management, rated by a field supervisor. The study observations took place in real clinical pre-hospital emergency medical cases when two or more crews were dispatched between October 2019 and August 2020. The sample size was determined by researchers prior to the study to at least 100 evaluated events per each of the three participating emergency medical services. The results are presented as median and interquartile range. The internal reliability, consistency and validity of test items and results were evaluated. The Kruskal-Wallis test and the post hoc Mann-Whitney U test with Bonferroni correction were used for multiple comparisons of three groups.ResultsA total of 359 events were evaluated. Surprisingly, the median value for all eight items was as high as 3.0 with a similar interquartile range of 1.0. There were no differences observed by case type (CPR vs. TRAUMA vs. MEDICAL) except from item 1. A post hoc analysis revealed that this difference is in favour of a higher rated performance of non-technical skills in CPR.ConclusionsThe overall result of the performance of non-technical skills can be regarded as very good and can serve for further evaluations. The crews achieved better parameters of NTS in leadership in resuscitation situations in comparison with general medical events.Trial registrationThe study is registered at Clinical Trials under the ID: NCT04503369 .

Project description:BackgroundPreoperative assessment is crucial to prevent the risk of complications of surgical operations and is usually focused on functional capacity. The increasing availability of wearable devices (smartwatches, trackers, rings, etc) can provide less intrusive assessment methods, reduce costs, and improve accuracy.ObjectiveThe aim of this study was to present and evaluate the possibility of using commercial smartwatch data, such as those retrieved from the Fitbit Inspire 2 device, to assess functional capacity before elective surgery and correlate such data with the current gold standard measure, the 6-Minute Walk Test (6MWT) distance.MethodsDuring the hospital visit, patients were evaluated in terms of functional capacity using the 6MWT. Patients were asked to wear the Fitbit Inspire 2 for 7 days (with flexibility of -2 to +2 days) after the hospital visit, before their surgical operation. Resting heart rate and daily steps data were retrieved directly from the smartwatch. Feature engineering techniques allowed the extraction of heart rate over steps (HROS) and a modified version of Non-Exercise Testing Cardiorespiratory Fitness. All measures were correlated with 6MWT.ResultsIn total, 31 patients were enrolled in the study (n=22, 71% men; n=9, 29% women; mean age 76.06, SD 4.75 years). Data were collected between June 2021 and May 2022. The parameter that correlated best with the 6MWT was the Non-Exercise Testing Cardiorespiratory Fitness index (r=0.68; P<.001). The average resting heart rate over the whole acquisition period for each participant had r=-0.39 (P=.03), even if some patients did not wear the device at night. The correlation of the 6MWT distance with the HROS evaluated at 1% quantile was significant, with Pearson coefficient of -0.39 (P=.04). Fitbit step count had a fair correlation of 0.59 with 6MWT (P<.001).ConclusionsOur study is a promising starting point for the adoption of wearable technology in the evaluation of functional capacity of patients, which was strongly correlated with the gold standard. The study also identified limitations in the availability of metrics, variability of devices, accuracy and quality of data, and accessibility as crucial areas of focus for future studies.

Project description:BackgroundElevated plasma or serum troponin, indicating perioperative myocardial injury (PMI), is common after noncardiac surgery. However, underlying mechanisms remain unclear. Acute coronary syndrome (ACS) is associated with the early appearance of circulating microRNAs, which regulate post-translational gene expression. We hypothesised that if PMI and ACS share pathophysiological mechanisms, common microRNA signatures should be evident.MethodsWe performed a nested case control study of samples obtained before and after noncardiac surgery from patients enrolled in two prospective observational studies of PMI (postoperative troponin I/T>99th centile). In cohort one, serum microRNAs were compared between patients with or without PMI, matched for age, gender, and comorbidity. Real-time polymerase chain reaction quantified (qRT-PCR) relative microRNA expression (cycle quantification [Cq] threshold <37) before and after surgery for microRNA signatures associated with ACS, blinded to PMI. In cohort two, we analysed (EdgeR) microRNA from plasma extracellular vesicles using next-generation sequencing (Illumina HiSeq 500). microRNA-messenger RNA-function pathway analysis was performed (DIANA miRPath v3.0/TopGO).ResultsMicroRNAs were detectable in all 59 patients (median age 67 yr [61-75]; 42% male), who had similar clinical characteristics independent of developing PMI. In cohort one, serum microRNA expression increased after surgery (mean fold-change) hsa-miR-1-3p: 3.99 (95% confidence interval [CI: 1.95-8.19]; hsa-miR-133-3p: 5.67 [95% CI: 2.94-10.91]; P<0.001). These changes were not associated with PMI. Bioinformatic analysis of differentially expressed microRNAs from cohorts one (n=48) and two (n=11) identified pathways associated with adrenergic stress and calcium dysregulation, rather than ischaemia.ConclusionsCirculating microRNAs associated with cardiac ischaemia were universally elevated in patients after surgery, independent of development of myocardial injury.

Dataset Information

PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study.

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PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study.

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