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1.
Colorectal Dis ; 26(6): 1266-1270, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38671592

ABSTRACT

AIM: Haemorrhoidal disease (HD) is one of the most common anal disorders in the adult population. Despite that, treatment options differ among different countries and specialists, even for the same grade of HD. The aim of this study is to evaluate the differences in patient demographics, surgeon preference for the treatment option, outcomes as well as patient satisfaction rate for the procedure using an office-based or surgical approach for the treatment of HD among International Society of University Colon and Rectal Surgeons (ISUCRS) and European Society of Coloproctology (ECSP) fellows. METHOD: A panel of the ISUCRS and ECSP members will answer questions that are included in a questionnaire about the treatment of HD. The questionnaire will be distributed electronically to ISUCRS and ECSP fellows included in our database and will remain open from 1 April 2024 to 31 May 2024. CONCLUSION: This multicentre, global prospective audit will be delivered by consultant colorectal and general surgeons as well as trainees. The data obtained will lead to a better understanding of the incidence of HD, treatment and diagnostic possibilities. This snapshot audit will be hypothesis generating and inform areas the need future prospective study.


Subject(s)
Colorectal Surgery , Hemorrhoids , Societies, Medical , Humans , Hemorrhoids/surgery , Colorectal Surgery/statistics & numerical data , Surveys and Questionnaires , Europe , Prospective Studies , Medical Audit , Ambulatory Surgical Procedures/statistics & numerical data , Surgeons/statistics & numerical data , Hemorrhoidectomy/methods , Male , Female , Adult
2.
Dis Colon Rectum ; 66(8): 1056-1066, 2023 08 01.
Article in English | MEDLINE | ID: mdl-35275596

ABSTRACT

BACKGROUND: It is controversial whether extensive resection of right-sided colon cancer confers oncological benefits. OBJECTIVE: The aim of this study was to evaluate short- and long-term outcomes of extended surgical removal of the mesocolon compared to the conventional approach. DESIGN: This was a retrospective population-based study. SETTING: Study is based on a prospectively maintained Danish Colorectal Cancer Group database. MAIN OUTCOME MEASURES: Primary outcome measures included local-regional recurrence in patients who underwent curative resection for right-sided colon cancer and 30-day postoperative complications. Distant metastasis, unplanned intraoperative adverse events, and 30- and 90-day postoperative mortality were also investigated. Patients who had palliative or compromised resection, emergency surgery, or neoadjuvant chemotherapy were excluded. RESULTS: Of the 12,855 patients with resection of right-sided colon cancer retrieved, 1151 underwent extended right hemicolectomy. Patients who had extended right hemicolectomy were younger males with lower ASA scores, were operated on by colorectal surgeons using a laparoscopic approach, and had a significantly higher number of harvested lymph nodes. The rate of local-regional recurrence was 1.1% (136/12,855), with no difference between conventional right hemicolectomy and extended right hemicolectomy (OR, 1.7; 95% CI, 0.63-2.18). Postoperative medical complications were significantly higher in extended right hemicolectomy even after adjusting for age, comorbidity, access to the abdomen, and other covariates (OR, 1.26; 95% CI, 1.01-1.58). No significant difference was noticed between conventional right hemicolectomy and extended right hemicolectomy in the rates of distant metastasis, unplanned intraoperative adverse events, and mortality. LIMITATIONS: Because it is a register-based study, underreporting cannot be excluded. Extended right hemicolectomy, as defined in this study, does not reflect the extent of lymphatic dissection performed during the surgery. CONCLUSIONS: This large population-based register study showed no difference in local-regional recurrence of right-sided colon cancer between conventional and extended right hemicolectomy with mesenteric resection and ligation of the middle colic vessels. Extended resection was associated with higher rates of postoperative complications. See Video Abstract at http://links.lww.com/DCR/B907 . LA RESECCIN AMPLIADA DEL COLON DERECHO NO REDUCE EL RIESGO DE RECURRENCIA LOCALREGIONAL DEL CNCER DE COLON ESTUDIO POBLACIONAL A NIVEL NACIONAL DE LA BASE DE DATOS DEL GRUPO DANS DE CNCER COLORRECTAL: ANTECEDENTES:Es aun un tema controversial si la resección ampliada del cáncer de colon del lado derecho confiere beneficios oncológicos.OBJETIVOS:El objetivo de este estudio fue examinar los resultados a corto y largo plazo de la resección quirúrgica ampliada del mesocolon en comparación con el enfoque convencional.DISEÑO:Este fue un estudio poblacional de tipo retrospectivo basado en una base de datos del Grupo Danés de Cáncer Colorrectal mantenida de manera prospectiva.AJUSTES:La medida de resultado primaria fue la recurrencia local-regional en pacientes sometidos a resección curativa por cáncer de colon del lado derecho y las medidas de resultado secundarias fueron las complicaciones posoperatorias a los 30 días. También fueron investigadas las metástasis a distancia, los eventos adversos intraoperatorios no planificados y la mortalidad posoperatoria a los 30 y 90 días. Se excluyeron los pacientes sometidos a resección paliativa o comprometida, cirugía de urgencia y quimioterapia neoadyuvante.RESULTADOS:De los 12.855 pacientes recuperados y sometidos a resección de cáncer de colon del lado derecho, 1151 fueron sometidos a hemicolectomía derecha ampliada. Los pacientes sometidos a hemicolectomía derecha ampliada fueron varones más jóvenes con puntuaciones ASA más bajas, operados por cirujanos colorrectales, utilizando la vía laparoscópica, y tuvieron un número significativamente mayor de ganglios linfáticos extraídos. La tasa de recidiva local-regional fue del 1,1% (136 / 12.855) sin diferencia entre la hemicolectomía derecha convencional y la hemicolectomía derecha ampliada (OR 1,7 IC 95% 0,63-2,18). Las complicaciones médicas post operatorias fueron significativamente mayores en la hemicolectomía derecha ampliada incluso después del ajuste por edad, comorbilidad, acceso al abdomen y otras covariables (OR 1,26; IC 95% 1,01-1,58). No se observaron diferencias significativas entre la hemicolectomía derecha convencional y la hemicolectomía derecha ampliada con respecto a las tasas de metástasis a distancia, eventos adversos intraoperatorios no planificados y mortalidad.LIMITACIONES:Es un estudio basado en registros, por lo tanto, no se puede excluir la sub notificación. La hemicolectomía derecha ampliada como se define en este estudio no refleja la extensión de la disección linfática realizada durante la cirugía.CONCLUSIONES:Este gran estudio basado en el registro poblacional no mostró diferencias en la recurrencia local-regional del cáncer de colon del lado derecho entre la hemicolectomía derecha convencional y ampliada con resección mesentérica y ligadura de los vasos cólicos medios. La resección ampliada se asoció con tasas más altas de complicaciones posoperatorias. Consulte Video Resumen en http://links.lww.com/DCR/B907 . (Traducción-Dr. Osvaldo Gauto ).


Subject(s)
Colonic Neoplasms , Rectal Neoplasms , Male , Humans , Retrospective Studies , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/pathology , Colonic Neoplasms/surgery , Colonic Neoplasms/pathology , Postoperative Complications/epidemiology , Postoperative Complications/pathology , Rectal Neoplasms/surgery , Neoplasm Staging
3.
Colorectal Dis ; 25(7): 1453-1459, 2023 07.
Article in English | MEDLINE | ID: mdl-37086006

ABSTRACT

AIM: Patients with Crohn's disease (CD) often suffer from perianal fistulizing disease. Their risk of anorectal cancer remains uncertain. We aimed to examine the long-term risk of anorectal cancer in a population-based cohort of CD patients with anorectal fistula. METHOD: Our study population covered all individuals (n = 7 987 520) aged 15+ years living in Denmark from 1978 to 2018. We identified all patients with CD and anorectal fistula in the Danish National Patient Register (NPR) and 50 matched noninflammatory bowel disease (IBD) individuals from the general population. Using Cox regression analyses, we examined the risk of anorectal cancer in CD fistula patients versus non-IBD individuals. All patients with CD were identified using codes from the International Classification of Diseases and their data extracted from the NPR. The main outcome measure was cases of anorectal cancer. RESULTS: A total of 2786 CD patients with anorectal fistula and 139 300 non-IBD individuals were followed for 1 553 917 person-years. During follow-up, anorectal cancer was observed in 19 CD patients (0.68%) and 340 non-IBD individuals (0.24%), corresponding to a 2.9-fold increased hazard ratio (HR) of anorectal cancer in CD fistula patients (95% CI 1.80-4.53), with a particularly high risk of anal cancer (HR 15.13, 95% CI 6.88-33.31) and a mean time from CD fistula diagnosis to anorectal cancer of 6.7 (SD 6.5) years. The risk was slightly higher in women than men and had no apparent relation to treatment with tumour necrosis factor-α inhibitors. Sensitivity analyses using CD nonfistula patients for comparison revealed similar results. Individual data on smoking and infection with human papilloma virus were not available. CONCLUSION: Patients with CD and anorectal fistula have a three-fold increased risk of anorectal cancer compared with the general population. The number needed to surveil to detect one case of anorectal cancer in this patient population was 2160 patients per year in patients with long-standing fistula (>6 years).


Subject(s)
Anus Neoplasms , Crohn Disease , Gastrointestinal Neoplasms , Rectal Diseases , Rectal Fistula , Rectal Neoplasms , Male , Humans , Female , Crohn Disease/complications , Crohn Disease/epidemiology , Cohort Studies , Anus Neoplasms/epidemiology , Anus Neoplasms/etiology , Rectal Neoplasms/etiology , Rectal Neoplasms/complications , Rectal Diseases/complications , Rectal Fistula/complications , Rectal Fistula/epidemiology , Denmark/epidemiology
4.
Colorectal Dis ; 25(5): 1014-1025, 2023 05.
Article in English | MEDLINE | ID: mdl-36747373

ABSTRACT

AIM: The burden of abdominal wound failure can be profound. Recent clinical guidelines have highlighted the heterogeneity of laparotomy closure techniques. The aim of this study was to investigate current midline closure techniques and practices for prevention of surgical site infection (SSI). METHOD: An online survey was distributed in 2021 among the membership of the European Society of Coloproctology and its partner societies. Surgeons were asked to provide information on how they would close the abdominal wall in three specific clinical scenarios and on SSI prevention practices. RESULTS: A total of 561 consultants and trainee surgeons participated in the survey, mainly from Europe (n = 375, 66.8%). Of these, 60.6% identified themselves as colorectal surgeons and 39.4% as general surgeons. The majority used polydioxanone for fascial closure, with small bite techniques predominating in clean-contaminated cases (74.5%, n = 418). No significant differences were found between consultants and trainee surgeons. For SSI prevention, more surgeons preferred the use of mechanical bowel preparation (MBP) alone over MBP and oral antibiotics combined. Most surgeons preferred 2% alcoholic chlorhexidine (68.4%) or aqueous povidone-iodine (61.1%) for skin preparation. The majority did not use triclosan-coated sutures (73.3%) or preoperative warming of the wound site (78.5%), irrespective of level of training or European/non-European practice. CONCLUSION: Abdominal wound closure technique and SSI prevention strategies vary widely between surgeons. There is little evidence of a risk-stratified approach to wound closure materials or techniques, with most surgeons using the same strategy for all patient scenarios. Harmonization of practice and the limitation of outlying techniques might result in better outcomes for patients and provide a stable platform for the introduction and evaluation of further potential improvements.


Subject(s)
Abdominal Wall , Abdominal Wound Closure Techniques , Surgeons , Triclosan , Humans , Surgical Wound Infection/prevention & control , Triclosan/therapeutic use , Abdominal Wall/surgery , Sutures , Suture Techniques
5.
Int J Colorectal Dis ; 36(2): 253-263, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33048241

ABSTRACT

PURPOSE: The study examined whether urgency of surgical intervention affects postoperative outcomes in patients with Crohn's disease (CD) undergoing bowel resection. METHOD: The review was conducted according to a predefined, published study protocol in Prospero which is an international database of prospectively registered systematic reviews in health. The study reported according to PRIMSMA guidelines. We searched Embase and Pubmed for articles reporting postoperative outcome after urgent and elective surgery in patients with CD undergoing bowel resection. Primary outcome variable was 30-day overall postoperative complications while secondary outcome variables were intraabdominal septic complications (IASCs), mortality, reoperation, and readmission. Assessment of bias was performed using Newcastle-Ottawa score. Two authors independently extracted data on each study, patients, and outcome measures. RESULTS: The search identified 22 studies in which 955 patients underwent urgent surgeries while 6518 patients underwent elective surgeries. Based on the quality assessment, 19 studies were classified as having high risk of bias, one study as having a medium risk of bias and 2 studies as having low risk of bias (≥ 8 stars). Random-effect metaanalysis showed urgent surgery was associated with ~ 40% increase in overall complications compared to elective surgery (RR = 1.43, 95% CI [1.09; 1.87], p = 0.010). IASCs also increased in patients who had urgent surgery (RR = 1.44, 95% CI [1.08; 1.92], p = 0.013). No significant difference was shown in mortality and readmission rates. CONCLUSION: Urgent bowel resection in patients with CD is associated with higher risk of overall postoperative complications and IASCs.


Subject(s)
Crohn Disease , Digestive System Surgical Procedures , Crohn Disease/surgery , Digestive System Surgical Procedures/adverse effects , Elective Surgical Procedures/adverse effects , Humans , Postoperative Complications/etiology , Postoperative Period
6.
Surg Innov ; 28(5): 560-566, 2021 Oct.
Article in English | MEDLINE | ID: mdl-33710930

ABSTRACT

Purpose. The primary aim of the study was to review the existing literature about patient-reported outcome measures (PROMs) in colorectal cancer and IBD. The secondary aim was to present a road map to develop a core outcome set via opinion gathering using social media. Method. This study is the first step of a three-step project aimed at constructing simple, applicable PROMs in colorectal surgery. This article was written in a collaborative manner with authors invited both through Twitter via the #OpenSourceResearch hashtag. The 5 most used PROMs were presented and discussed as slides/images on Twitter. Inputs from a wide spectrum of participants including researchers, surgeons, physicians, nurses, patients, and patients' organizations were collected and analyzed. The final draft was emailed to all contributors and 6 patients' representatives for proofreading and approval. Results. Five PROM sets were identified and discussed: EORTC QLQ-CR29, IBDQ short health questionnaire, EORTC QLQ-C30, ED-Q5-5L, and Short Form-36. There were 315 tweets posted by 50 tweeters with 1458 retweets. Awareness about PROMs was generally limited. The general psycho-physical well-being score (GPP) was suggested and discussed, and then a survey was conducted in which more than 2/3 of voters agreed that GPP covers the most important aspects in PROMs. Conclusion. Despite the limitations of this exploratory study, it offered a new method to conduct clinical research with opportunity to engage patients. The general psycho-physical well-being score suggested as simple, applicable PROMs to be eventually combined procedure-specific, disease-specific, or symptom-specific PROMs if needed.


Subject(s)
Colorectal Surgery , Humans , Patient Reported Outcome Measures , Quality of Life , Surveys and Questionnaires
7.
Int J Colorectal Dis ; 34(11): 1925-1931, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31659447

ABSTRACT

PURPOSE: To investigate factors that influence postoperative in-hospital length of stay (LOS) in patients with Crohn's disease (CD) undergoing bowel surgery. Furthermore, the study aimed to evaluate LOS as a surrogate for postoperative outcome. METHODS: This is a multicentre retrospective cohort study. Inclusion criteria were adult patients with CD who underwent bowel surgery with either anastomosis or stricturoplasty. All timings of surgeries were included regardless of the method of access to the abdominal cavities. Patients with stoma were excluded. Demographic data, preoperative medications, previous operations for CD, preoperative sepsis, and operation were recorded. Primary outcome was LOS while secondary outcome variable was postoperative complications. RESULTS: A total of 449 patients who underwent abdominal surgery for CD were included. Of the 449 patients, 265 were female (59%). Median age was 37 years (IQR = 20), median LOS was 7 days (IQR = 6). Patients with longer LOS had higher rates of re-laparotomy/re-laparoscopy (45/228 (19.7%) versus 9/219 (4.1%) p = 0.01). In multivariate analysis, age (OR = 1.024 [CI 95% 1.007-1.041], p = 0.005), preoperative intra-abdominal abscess (OR = 0.39 [CI 95% 0.185-0.821], p = 0.013), and previous laparotomy/laparoscopy (OR = 0.57 [CI 95% 0.334-0.918], p = 0.021) were associated with prolonged LOS. LOS correlated with postoperative complications after adjustment for age, gender, previous laparotomy/laparoscopy, and preoperative intra-abdominal abscesses (OR = 1.28 [CI 95% 1.199-1.366], p < 0.0001). CONCLUSION: Age, preoperative intra-abdominal abscess, and previous laparotomy/laparoscopy significantly prolonged LOS. LOS correlated with postoperative complications and can therefore be used in epidemiological or register-based studies as a surrogate for postoperative outcome.


Subject(s)
Crohn Disease/pathology , Crohn Disease/surgery , Intestines/surgery , Length of Stay , Preoperative Care , Adult , Constriction, Pathologic , Female , Humans , Male , Postoperative Period
8.
BMC Surg ; 18(1): 91, 2018 Nov 03.
Article in English | MEDLINE | ID: mdl-30390672

ABSTRACT

BACKGROUND: TNF-α plays a role in angiogenesis and collagen synthesis, both essential in the wound healing process. There are concerns that pre-operative anti-TNF-α treatment may influence the surgical stress response and increase the risk of surgical complications. The aim of this study was to describe the surgical stress response in patients with inflammatory bowel disease (IBD) and to investigate whether the pre-operative administration of anti-tumor necrosis factor alpha (anti-TNF-α) agents modify the surgical stress response. METHODS: This was a prospective, multi-center cohort pilot study. The primary outcome was the change in concentration of immunological biomarkers of the surgical stress response (TNF-α, IL-6, and IL-10). Secondary outcome measures were changes in IL-8, IL-17A, C-reactive protein, white blood cells, cortisol, transferrin, ferritin, and D-Dimer in addition to 30 days' post-operative complications and length of post-operative stay in the hospital (LOS). RESULTS: Forty-six patients with IBD undergoing major abdominal surgery were included, and 18 received anti-TNF- α treatment pre-operatively. Peak increase of most of the immunological biomarkers occurred 6 hours after surgical incision. Then the concentration decreased after 24 h followed by a plateau at 48 h. After adjusting for confounders including detectable blood concentrations, no difference in the concentrations of immunological, endocrinological or haematological biomarkers of stress was found between anti-TNF-α treated and anti-TNF-α naïve patients. No increase in post-operative complications or LOS was noticed in patients who received anti-TNF-α treatment. CONCLUSIONS: Anti-TNF-α did not affect surgical stress response in this pilot study. Withdrawal of anti-TNF-α drugs prior to surgical intervention in IBD patients might not be justified without measurement of drug concentration and drug antibodies. TRIAL REGISTRATION: Clinicaltrails.gov.: NCT01974869 .


Subject(s)
Cytokines/blood , Digestive System Surgical Procedures , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Postoperative Complications/prevention & control , Adult , Biomarkers/blood , Female , Gastrointestinal Agents/therapeutic use , Humans , Inflammatory Bowel Diseases/blood , Inflammatory Bowel Diseases/surgery , Male , Pilot Projects , Postoperative Complications/blood , Preoperative Period , Prospective Studies , Risk Factors , Tumor Necrosis Factor-alpha/antagonists & inhibitors
9.
Int J Colorectal Dis ; 32(12): 1663-1676, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29051981

ABSTRACT

PURPOSE: Surgical management of inflammatory bowel disease (IBD) is a challenging task. The aim of preoperative optimization (PO) is to decrease the risk of complications and reduce the length of postoperative stay. The aim of this study was to review and grade the available evidence, attain clear recommendations, and point out potential future research. METHODS: Studies were identified from electronic databases (PubMed, Embase, and Cochrane Library) and scanning reference lists in relevant papers. English-written studies examining PO in adult patients with IBD were included. Eight PO factors were investigated. RESULTS: Management of IBD is a multidisciplinary task. Steroid withdrawal is recommended while steroid stress dose is not recommended. Thiopurines appear to be safe, but it may be prudent to plan the procedure remotely from the last dose of an anti-TNF agent. Nutritional risk screening is recommended to unveil and correct any malnutrition. Thrombosis prophylaxis prior to surgery is well supported by evidence while extended 4-week prophylaxis needs further research. Percutaneous ultrasound or CT-guided drainage for intra-abdominal abscesses is recommended, but it is unclear for how long supplementary antibiotics (ABs) should be used. Oral AB 24 h prior to open surgery might improve outcome if given as complementary to IV perioperative AB. Mechanical bowel preparation is not supported by evidence. Comorbidities must be treated accordingly prior to surgical intervention. Smoking cessation can be beneficial for wound healing. CONCLUSION: Multimodel PO intervention in IBD patients is recommended.


Subject(s)
Digestive System Surgical Procedures , Inflammatory Bowel Diseases/surgery , Preoperative Care , Antibiotic Prophylaxis , Biological Products/administration & dosage , Biological Products/adverse effects , Comorbidity , Digestive System Surgical Procedures/adverse effects , Drug Administration Schedule , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Humans , Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/immunology , Inflammatory Bowel Diseases/physiopathology , Length of Stay , Nutrition Assessment , Nutritional Status , Odds Ratio , Postoperative Complications/prevention & control , Preoperative Care/adverse effects , Purines/administration & dosage , Purines/adverse effects , Risk Factors , Smoking Cessation , Steroids/administration & dosage , Steroids/adverse effects , Time Factors , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Tumor Necrosis Factor-alpha/immunology
10.
Int J Colorectal Dis ; 32(1): 49-56, 2017 Jan.
Article in English | MEDLINE | ID: mdl-27785551

ABSTRACT

BACKGROUND: The timing of surgical intervention in Crohn's disease (CD) may depend on pre-operative optimization (PO) which includes different interventions to decrease the risk for unfavourable post-operative outcome. The objective of this study was to investigate the effect of multi-model PO on the post-operative outcome in CD. METHOD: This is a multicentre retrospective cohort study. The primary outcome was 30-day post-operative complications. Secondary outcomes were intra-abdominal septic complications, surgical site infection (SSI), re-operation, length of post-operative stay in a hospital and re-admission. PO included nutritional support, discontinuation of medications, pre-operative antibiotic course and thrombosis prophylaxis. RESULTS: Two hundred and thirty-seven CD elective bowel resections were included. Mean age was 39.9 years SD 14.25, 144 (60.8 %) were female and 129 (54.4 %) had one or more types of medical treatment pre-operatively. Seventy-seven patients (32.5 %) optimized by at least nutritional support or change in pre-operative medications. PO patients were more likely to have penetrating disease phenotype (p = 0.034), lower albumin (p = 0.015) and haemoglobin (p = 0.021) compared to the non-optimized. Multivariate analyses showed that treatment with anti-TNF alpha agents OR 2.058 CI [1.043-4.4.064] and low haemoglobin OR 0.741 CI [0.572-0.0.961] increased the risk of overall post-operative complications. Co-morbidity increased the risk of SSI OR 2.567 CI [1.182-5.576] while low haemoglobin was a risk factor for re-admission OR 0.613 CI [0.405-0.926]. Low pre-operative albumin correlated with longer stay in hospital. CONCLUSIONS: PO did not change post-operative outcome most likely due to selection bias. Anti-TNF alpha agents, low haemoglobin, low albumin and co-morbidity were associated with unfavourable outcome.


Subject(s)
Crohn Disease/surgery , Preoperative Care , Adolescent , Adult , Aged , Crohn Disease/drug therapy , Dose-Response Relationship, Drug , Female , Hemoglobins/metabolism , Humans , Male , Middle Aged , Postoperative Period , Serum Albumin/metabolism , Steroids/therapeutic use , Treatment Outcome , Young Adult
14.
Patterns (N Y) ; 5(4): 100946, 2024 Apr 12.
Article in English | MEDLINE | ID: mdl-38645766

ABSTRACT

Data bias is a major concern in biomedical research, especially when evaluating large-scale observational datasets. It leads to imprecise predictions and inconsistent estimates in standard regression models. We compare the performance of commonly used bias-mitigating approaches (resampling, algorithmic, and post hoc approaches) against a synthetic data-augmentation method that utilizes sequential boosted decision trees to synthesize under-represented groups. The approach is called synthetic minority augmentation (SMA). Through simulations and analysis of real health datasets on a logistic regression workload, the approaches are evaluated across various bias scenarios (types and severity levels). Performance was assessed based on area under the curve, calibration (Brier score), precision of parameter estimates, confidence interval overlap, and fairness. Overall, SMA produces the closest results to the ground truth in low to medium bias (50% or less missing proportion). In high bias (80% or more missing proportion), the advantage of SMA is not obvious, with no specific method consistently outperforming others.

15.
Sci Rep ; 14(1): 6978, 2024 03 24.
Article in English | MEDLINE | ID: mdl-38521806

ABSTRACT

Synthetic data generation is being increasingly used as a privacy preserving approach for sharing health data. In addition to protecting privacy, it is important to ensure that generated data has high utility. A common way to assess utility is the ability of synthetic data to replicate results from the real data. Replicability has been defined using two criteria: (a) replicate the results of the analyses on real data, and (b) ensure valid population inferences from the synthetic data. A simulation study using three heterogeneous real-world datasets evaluated the replicability of logistic regression workloads. Eight replicability metrics were evaluated: decision agreement, estimate agreement, standardized difference, confidence interval overlap, bias, confidence interval coverage, statistical power, and precision (empirical SE). The analysis of synthetic data used a multiple imputation approach whereby up to 20 datasets were generated and the fitted logistic regression models were combined using combining rules for fully synthetic datasets. The effects of synthetic data amplification were evaluated, and two types of generative models were used: sequential synthesis using boosted decision trees and a generative adversarial network (GAN). Privacy risk was evaluated using a membership disclosure metric. For sequential synthesis, adjusted model parameters after combining at least ten synthetic datasets gave high decision and estimate agreement, low standardized difference, as well as high confidence interval overlap, low bias, the confidence interval had nominal coverage, and power close to the nominal level. Amplification had only a marginal benefit. Confidence interval coverage from a single synthetic dataset without applying combining rules were erroneous, and statistical power, as expected, was artificially inflated when amplification was used. Sequential synthesis performed considerably better than the GAN across multiple datasets. Membership disclosure risk was low for all datasets and models. For replicable results, the statistical analysis of fully synthetic data should be based on at least ten generated datasets of the same size as the original whose analyses results are combined. Analysis results from synthetic data without applying combining rules can be misleading. Replicability results are dependent on the type of generative model used, with our study suggesting that sequential synthesis has good replicability characteristics for common health research workloads.


Subject(s)
Benchmarking , Disclosure , Computer Simulation , Logistic Models , Mental Processes
16.
J Crohns Colitis ; 2024 Jun 15.
Article in English | MEDLINE | ID: mdl-38878002

ABSTRACT

This article is the second in a series of two publications on the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of Crohn's disease. The first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations. Both articles together represent the evidence-based recommendations of the ECCO for Crohn's disease and an update of prior ECCO guidelines.

17.
Dis Colon Rectum ; 56(12): 1423-33, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24201398

ABSTRACT

BACKGROUND: Patients with Crohn's disease treated with anti-tumor necrosis factor alpha agents may have an increased risk of surgical complications. OBJECTIVE: We assessed the effect of anti-tumor necrosis factor alpha on postoperative complications in patients with Crohn's disease undergoing abdominal surgery. DATA SOURCES: Studies were identified through electronic and manual searches. STUDY SELECTION: Observational studies on patients with Crohn's disease undergoing laparoscopic or open abdominal surgery were included. INTERVENTIONS: Anti-tumor necrosis factor alpha agents were administered within 3 months before surgery. MAIN OUTCOME MEASURES: The primary outcome was anastomotic complications including overt dehiscence, intra-abdominal abscess, and enteric fistulas. RESULTS: Fourteen studies on 679 patients in the intervention (anti-tumor necrosis factor alpha) group and 2363 controls were included. Random-effects meta-analysis found no difference in anastomotic complications between the 2 groups (7.6% versus 8.2%; risk ratio, 0.91; 95% CI, 0.56-1.48). There was clear heterogeneity between studies. In subgroup analyses, the anti-tumor necrosis factor alpha increased anastomotic complications in trials with a lower risk of bias, but not in the studies with a higher bias risk (risk ratio, 1.63; 95% CI, 1.03-2.60 and risk ratio, 0.17; 95% CI, 0.05-0.60). In the overall analysis and in studies with a lower bias risk, anti-tumor necrosis factor alpha agents increased the risk of nonanastomotic surgical complications, major medical complications, and minor medical complications. LIMITATIONS: Limitations of observations studies. CONCLUSIONS: In studies with a low risk of bias, anti-tumor necrosis factor alpha agents increased the risk of anastomotic complications. Inadequate bias control may lead to an underestimated risk of anastomotic complications.


Subject(s)
Anti-Inflammatory Agents/adverse effects , Crohn Disease/surgery , Intestines/surgery , Postoperative Complications/etiology , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Wound Healing/immunology , Abdominal Abscess/etiology , Anastomosis, Surgical , Anastomotic Leak/etiology , Anti-Inflammatory Agents/immunology , Crohn Disease/drug therapy , Humans , Intestinal Fistula/etiology , Postoperative Complications/immunology , Risk Factors , Tumor Necrosis Factor-alpha/immunology
18.
BJS Open ; 7(1)2023 01 06.
Article in English | MEDLINE | ID: mdl-36802245

ABSTRACT

AIM: The aim of this study was to investigate the trends in morbidity and mortality of patients with right-sided colonic cancer who had an emergency surgical procedure in Denmark after the introduction of quality index parameters. METHODS: This was a retrospective nationwide study based on a prospectively maintained Danish Colorectal Cancer Group database focused on right-sided colonic cancer in the interval from 1 May 2001 to 30 April 2018, who underwent emergency surgical intervention (within 48 h of hospital admission). The primary objective was to investigate the trends in morbidity and mortality throughout the study years. Multivariable estimates were adjusted for age, sex, smoking status, alcohol consumption, ASA score classification, tumour localization, type of access to abdominal cavity, surgeon's grade of specialization, and metastatic disease. RESULTS: Out of 2839 patients, a total of 2740 patients fulfilled the inclusion criteria, of whom 2464 underwent right or transverse colon resection (89.9 per cent). The 30-day and 90-day postoperative mortality rates were significantly reduced over the time of the study (OR 0.943, 95 per cent c.i. 0.922 to 0.965, P < 0.001 and OR 0.953, 95 per cent c.i. 0.934 to 0.972, P < 0.001 respectively); however, the complication rates did not follow this trend. Older patients (OR 1.032, 95 per cent c.i. 1.009 to 1.055, P = 0.005) and patients with high ASA scores (OR 1.61, 95 per cent c.i. 1.422 to 1.830, P < 0.001) had higher rates of severe grade 3b postoperative complications. A stoma was constructed in 276 patients (10 per cent), whereas a stent was used in only eight patients. Defunctioning procedures, including stoma construction or colonic stenting (without oncological resection), did not reduce the risk of complications compared with that of definitive surgery. CONCLUSION: The 30-day and 90-day postoperative mortality rates were significantly reduced over the time of the study. Age and ASA score were risk factors for severe postoperative complications.


Subject(s)
Colonic Neoplasms , Humans , Retrospective Studies , Colonic Neoplasms/pathology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Denmark/epidemiology
19.
Surgery ; 174(1): 46-51, 2023 07.
Article in English | MEDLINE | ID: mdl-37156647

ABSTRACT

BACKGROUND: Anastomosis leak is one of the significant postoperative complications after colorectal surgery. The aim of this systematic review was to synthesize the evidence relative to the preoperative assessment of the colon and rectum blood supply and to investigate its role in predicting anastomosis leak. METHOD: This systematic review was conducted according to the recommendations of the Cochrane Handbook for Reviews of Interventions and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. PubMed, Embase, and the Cochrane Library were searched to identify eligible studies. The main outcome variable was the preoperative assessment of patterns of blood supply to the colon and the impact of these patterns on anastomosis leak. The quality of bias control in the studies was assessed using the Newcastle-Ottawa Scale. Due to the heterogeneous nature of the included studies, no meta-analysis was conducted. RESULTS: Fourteen studies were included. The study covered a period from 1978 to 2021. A significant degree of variation in the arterial and/or venous supply of the colon and rectum might influence anastomosis leak rates. Calcification in great blood vessels can be assessed with a preoperative computed tomography scan, which may predict anastomosis leak rates. This is supported by many experimental studies that showed increased rates of anastomosis leak after preoperative ischemia, but the extent of this impact is not well established. CONCLUSION: Preoperative assessment of blood supply to the colon and rectum might help in planning the surgical intervention to reduce anastomosis leak rates. Calcium scoring of major arteries might predict anastomosis leak and thus play a crucial role in intraoperative decision-making.


Subject(s)
Anastomotic Leak , Colon , Humans , Anastomotic Leak/diagnosis , Anastomotic Leak/etiology , Anastomosis, Surgical/adverse effects , Anastomosis, Surgical/methods , Colon/surgery , Postoperative Complications/diagnosis , Postoperative Complications/etiology , Rectum/surgery
20.
J Crohns Colitis ; 17(2): 153-169, 2023 Mar 18.
Article in English | MEDLINE | ID: mdl-36055337

ABSTRACT

BACKGROUND AND AIMS: Despite the advances in medical therapies, a significant proportion of patients with inflammatory bowel diseases [IBD] require surgical intervention. This Topical Review aims to offer expert consensus practice recommendations for peri-operative care to optimize outcomes of IBD patients who undergo surgery. METHODS: A multidisciplinary panel of IBD healthcare providers systematically reviewed aspects relevant to peri-operative care in IBD. Consensus statements were developed using Delphi methodology. RESULTS: A total of 20 current practice positions were developed following systematic review of the current literature covering use of medication in the peri-operative period, nutritional assessment and intervention, physical and psychological rehabilitation and prehabilitation, and immediate postoperative care. CONCLUSION: Peri-operative planning and optimization of the patient are imperative to ensure favourable outcomes and reduced morbidity. This Topical Review provides practice recommendations applicable in the peri-operative period in IBD patients undergoing surgery.


Subject(s)
Inflammatory Bowel Diseases , Humans , Inflammatory Bowel Diseases/drug therapy , Inflammatory Bowel Diseases/surgery , Postoperative Care
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