RESUMO
Importance: Minimally invasive esophagectomy (MIE) is a complex procedure with substantial learning curves. In other complex minimally invasive procedures, suboptimal surgical performance has convincingly been associated with less favorable patient outcomes as assessed by peer review of the surgical procedure. Objective: To develop and validate a procedure-specific competency assessment tool (CAT) for MIE. Design, Setting, and Participants: In this international quality improvement study, a procedure-specific MIE-CAT was developed and validated. The MIE-CAT contains 8 procedural phases, and 4 quality components per phase are scored with a Likert scale ranging from 1 to 4. For evaluation of the MIE-CAT, intraoperative MIE videos performed by a single surgical team in the Esophageal Center East Netherlands were peer reviewed by 18 independent international MIE experts (with more than 120 MIEs performed). Each video was assessed by 2 or 3 blinded experts to evaluate feasibility, content validity, reliability, and construct validity. MIE-CAT version 2 was composed with refined content aimed at improving interrater reliability. A total of 32 full-length MIE videos from patients who underwent MIE between 2011 and 2020 were analyzed. Data were analyzed from January 2021 to January 2023. Exposure: Performance assessment of transthoracic MIE with an intrathoracic anastomosis. Main Outcomes and Measures: Feasibility, content validity, interrater and intrarater reliability, and construct validity, including correlations with both experience of the surgical team and clinical parameters, of the developed MIE-CAT. Results: Experts found the MIE-CAT easy to understand and easy to use to grade surgical performance. The MIE-CAT demonstrated good intrarater reliability (range of intraclass correlation coefficients [ICCs], 0.807 [95% CI, 0.656 to 0.892] for quality component score to 0.898 [95% CI, 0.846 to 0.932] for phase score). Interrater reliability was moderate (range of ICCs, 0.536 [95% CI, -0.220 to 0.994] for total MIE-CAT score to 0.705 [95% CI, 0.473 to 0.846] for quality component score), and most discrepancies originated in the lymphadenectomy phases. Hypothesis testing for construct validity showed more than 75% of hypotheses correct: MIE-CAT performance scores correlated with experience of the surgical team (r = 0.288 to 0.622), blood loss (r = -0.034 to -0.545), operative time (r = -0.309 to -0.611), intraoperative complications (r = -0.052 to -0.319), and severe postoperative complications (r = -0.207 to -0.395). MIE-CAT version 2 increased usability. Interrater reliability improved but remained moderate (range of ICCs, 0.666 to 0.743), and most discrepancies between raters remained in the lymphadenectomy phases. Conclusions and Relevance: The MIE-CAT was developed and its feasibility, content validity, reliability, and construct validity were demonstrated. By providing insight into surgical performance of MIE, the MIE-CAT might be used for clinical, training, and research purposes.
Assuntos
Neoplasias Esofágicas , Esofagectomia , Humanos , Esofagectomia/efeitos adversos , Neoplasias Esofágicas/cirurgia , Reprodutibilidade dos Testes , Excisão de Linfonodo/efeitos adversos , Complicações Pós-Operatórias/etiologiaRESUMO
BACKGROUND: Quilting, a technique in which skin flaps are sutured to the underlying muscle, reduces seroma after mastectomy and/or axillary lymph node dissection. The aim of this study was to assess the effect of different quilting techniques on the formation of clinically significant seroma. METHODS: This was a retrospective study including patients undergoing mastectomy and/or axillary lymph node dissection. Four breast surgeons applied the quilting technique based on their own discretion. Technique 1 was performed using Stratafix in 5-7 rows placed at 2-3â cm distance. Technique 2 was performed using Vicryl 2-0 in 4-8 rows placed at 1.5-2â cm distance. Technique 3 was performed using Vicryl 0/1 in 3 rows placed at 3-4â cm distance. Technique 4 was performed using Vicryl 0 in 4-5 rows placed at 1.5â cm distance. The primary outcome was clinically significant seroma. RESULTS: A total of 445 patients were included. Clinically significant seroma incidence was 4.1 per cent (six of 147) for technique 1, which was significantly lower than that for the other techniques (25.0 per cent (29 of 116), 29.4 per cent (32 of 109), and 33 per cent (24 of 73) for techniques 2, 3, and 4 (P < 0.001) respectively). The duration of surgery was not significantly longer for technique 1 compared with the other three techniques. The length of hospital stay, number of additional visits to the outpatient clinic, and reoperations did not differ significantly between the four techniques. CONCLUSION: Quilting using Stratafix and placing 5-7 rows with 2-3â cm distance between the stitches associates with low clinically significant seroma incidence without adverse effects.
Assuntos
Neoplasias da Mama , Mastectomia , Humanos , Feminino , Mastectomia/efeitos adversos , Mastectomia/métodos , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Seroma/epidemiologia , Seroma/etiologia , Seroma/prevenção & controle , Neoplasias da Mama/cirurgia , Poliglactina 910 , Técnicas de Sutura/efeitos adversos , Drenagem/efeitos adversos , Drenagem/métodosRESUMO
BACKGROUND: Minimally invasive esophagectomy (MIE) is a complex and technically demanding procedure with a long learning curve, which is associated with increased morbidity and mortality. To master MIE, training in essential steps is crucial. Yet, no consensus on essential steps of MIE is available. The aim of this study was to achieve expert consensus on essential steps in Ivor Lewis and McKeown MIE through Delphi methodology. METHODS: Based on expert opinion and peer-reviewed literature, essential steps were defined for Ivor Lewis (IL) and McKeown (McK) MIE. In a round table discussion, experts finalized the lists of steps and an online Delphi questionnaire was sent to an international expert panel (7 European countries) of minimally invasive upper GI surgeons. Based on replies and comments, steps were adjusted and rephrased and sent in iterative fashion until consensus was achieved. RESULTS: Two Delphi rounds were conducted and response rates were 74% (23 out of 31 experts) for the first and 81% (27 out of 33 experts) for the second round. Consensus was achieved on 106 essential steps for both the IL and McK approach. Cronbach's alpha in the first round was 0.78 (IL) and 0.78 (McK) and in the second round 0.92 (IL) and 0.88 (McK). CONCLUSIONS: Consensus among European experts was achieved on essential surgical steps for both Ivor Lewis and McKeown minimally invasive esophagectomy.
Assuntos
Neoplasias Esofágicas , Esofagectomia , Consenso , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Humanos , Curva de Aprendizado , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Complicações Pós-Operatórias/cirurgia , Estudos RetrospectivosRESUMO
INTRODUCTION: Totally minimally invasive esophagectomy (TMIE) is increasingly used in treatment of patients with esophageal carcinoma. However, it is currently unknown if McKeown TMIE or Ivor Lewis TMIE should be preferred for patients in whom both procedures are oncologically feasible. METHODS: The study was performed in 4 high-volume Dutch esophageal cancer centers between November 2009 and April 2017. Prospectively collected data from consecutive patients with esophageal cancer localized in the distal esophagus or gastroesophageal junction undergoing McKeown TMIE or Ivor Lewis TMIE were included. Patients were propensity score matched for age, body mass index, sex, American Society of Anesthesiologists classification, Charlson Comorbidity Index, tumor type, tumor location, clinical stage, neoadjuvant treatment, and the hospital of surgery. The primary outcome parameter was anastomotic leakage requiring reintervention or reoperation. Secondary outcome parameters were operation characteristics, pathology results, complications, reinterventions, reoperations, length of stay, and mortality. RESULTS: Of all 787 included patients, 420 remained after matching. The incidence of anastomotic leakage requiring reintervention or reoperation was 23.3% after McKeown TMIE versus 12.4% after Ivor Lewis TMIE (P = 0.003). Ivor Lewis TMIE was significantly associated with a lower incidence of pulmonary complications (46.7% vs 31.9%), recurrent laryngeal nerve palsy (9.5% vs 0.5%), reoperations (18.6% vs 11.0%), 90-day mortality (7.1% vs 2.9%), shorter median intensive care unit length of stay (2 days vs 1 day) and shorter median hospital length of stay (12 vs 11 days) (all P < 0.05). R0 resection rate was similar between the groups. The median number of examined lymph nodes was 21 after McKeown TMIE and 25 after Ivor Lewis TMIE (P < 0.001). CONCLUSIONS: Ivor Lewis TMIE is associated with a lower incidence of anastomotic leakage, 90-day mortality and other postoperative morbidity compared to McKeown TMIE in patients in whom both procedures are oncologically feasible.
Assuntos
Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Laparoscopia/métodos , Estadiamento de Neoplasias , Complicações Pós-Operatórias/epidemiologia , Pontuação de Propensão , Idoso , Neoplasias Esofágicas/diagnóstico , Neoplasias Esofágicas/mortalidade , Feminino , Seguimentos , Humanos , Incidência , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND: The number of elderly patients suffering from esophageal cancer is increasing, due to an increasing incidence of esophageal cancer and increasing life expectancy. However, the effect of age on morbidity, mortality, and survival after Ivor Lewis total minimally invasive esophagectomy (TMIE) is not well known. METHODS: A prospectively documented database from December 2010 to June 2017 was analyzed, including all patients who underwent Ivor Lewis TMIE for esophageal cancer in three Dutch high-volume esophageal cancer centers. Patients younger than 75 years (younger group) were compared to patients aged 75 years or older (elderly group). Baseline patient characteristics and perioperative data were included. Surgical complications were graded using the Clavien-Dindo scale. The primary outcome was postoperative complications Clavien-Dindo ≥ 3. Secondary outcome parameters were postoperative complications, in-hospital mortality, 30- and 90-day mortality and survival. RESULTS: Four hundred and forty-six patients were included, 357 in the younger and 89 in the elderly group. No significant differences were recorded regarding baseline patient characteristics. There was no significant difference in complications graded Clavien-Dindo ≥ 3 and overall complications, short-term mortality, and survival. Delirium occurred in 27.0% in the elderly and 11.8% in the younger group (p < 0.001). After correction for baseline comorbidity this difference remained significant (p = 0.001). Median hospital length of stay was 13 days in the elderly and 11 days in the younger group (p = 0.010). CONCLUSIONS: Ivor Lewis TMIE can be safely performed in selected elderly patients without increasing postoperative morbidity and mortality.
Assuntos
Neoplasias Esofágicas/cirurgia , Esofagectomia/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Fatores Etários , Idoso , Neoplasias Esofágicas/mortalidade , Esofagectomia/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/mortalidade , Complicações Pós-Operatórias/mortalidade , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
OBJECTIVE: To investigate the morbidity that is associated with the learning curve of minimally invasive esophagectomy. BACKGROUND: Although learning curves have been described, it is currently unknown how much extra morbidity is associated with the learning curve of technically challenging surgical procedures. METHODS: Prospectively collected data were retrospectively analyzed of all consecutive patients undergoing minimally invasive Ivor Lewis esophagectomy in 4 European expert centers. The primary outcome parameter was anastomotic leakage. Secondary outcome parameters were operative time and textbook outcome ("optimal outcome"). Learning curves were plotted using weighted moving average and CUSUM analysis was used to determine after how many cases the plateau was reached. Learning associated morbidity was calculated with area under the curve analysis. RESULTS: This study included 646 patients. Three of the 4 hospitals reached the plateau of 8% anastomotic leakage. The length of the learning curve was 119 cases. The mean incidence of anastomotic leakage decreased from 18.8% during the learning phase to 4.5% after the plateau had been reached (P < 0.001). Thirty-six extra patients (10.1% of all patients operated on during the learning curve) experienced learning associated anastomotic leakage, that could have been avoided if patients were operated by surgeons who had completed the learning curve. The incidence of textbook outcome increased from 28% to 53% and the mean operative time decreased from 344âminutes to 270âminutes. CONCLUSIONS: A considerable number of 36 extra patients (10.1%) experienced learning associated anastomotic leakage. More research is urgently needed to investigate how learning associated morbidity can be reduced to increase patient safety during learning curves.
Assuntos
Educação de Pós-Graduação em Medicina/métodos , Neoplasias Esofágicas/cirurgia , Esofagectomia/educação , Curva de Aprendizado , Procedimentos Cirúrgicos Minimamente Invasivos/educação , Complicações Pós-Operatórias/epidemiologia , Cirurgiões/educação , Idoso , Competência Clínica , Esofagectomia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Morbidade/tendências , Países Baixos/epidemiologia , Duração da Cirurgia , Estudos Retrospectivos , Taxa de Sobrevida/tendênciasRESUMO
BACKGROUND: The aim of this study was to investigate whether gentamicin-collagen (GC) sponges can lower the incidence of seroma and surgical site infections following breast cancer surgery. PATIENTS AND METHODS: A retrospective cohort study was performed. Two consecutive cohorts of patients who underwent a mastectomy with or without an axillary lymph node dissection were compared. The first cohort was treated conventionally (n = 38), the second cohort received GC sponges (n = 39). Endpoints were the incidence of clinical significant seroma (CSS) and surgical site infections (SSI), the mean number of aspirations, and the mean aspirated volume. RESULTS: GC sponges lowered the CSS incidence from 73.7% to 38.5% (P = .002). The mean number of aspirations and the mean aspirated volume were not affected. SSI incidence was 15.8% in the conventional cohort compared with 7.7% in the GC cohort (P = .23). CONCLUSION: Application of GC sponges significantly lowered the incidence of CSS. The incidence of SSI was halved, although this was not significant.
Assuntos
Neoplasias da Mama/cirurgia , Colágeno/administração & dosagem , Gentamicinas/administração & dosagem , Mastectomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Seroma/prevenção & controle , Idoso , Axila , Drenagem/instrumentação , Feminino , Humanos , Excisão de Linfonodo/efeitos adversos , Linfonodos/cirurgia , Pessoa de Meia-Idade , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/prevenção & controleRESUMO
BACKGROUND: Both cervical esophagogastric anastomosis (CEA) and intrathoracic esophagogastric anastomosis (IEA) are used to restore gastrointestinal integrity following minimally invasive esophagectomy (MIE). No prospective randomized data on functional outcome, postoperative morbidity, and mortality between these techniques are currently available. METHODS: A comparison was conducted including all consecutive patients with esophageal carcinoma of the distal esophagus or gastroesophageal junction undergoing MIE with CEA or MIE with IEA from October 2009 to July 2014 in 3 high-volume esophageal cancer centers. Functional outcome, postoperative morbidity, and mortality were analyzed. RESULTS: MIE with CEA was performed in 146 patients and MIE with IEA in 210 patients. The incidence of recurrent laryngeal nerve palsy was 14.4% after CEA and 0% after IEA (p < 0.001). Dysphagia, dumping, and regurgitation were reported less frequently after IEA compared with CEA (p < 0.05). Dilatation of benign strictures occurred in 43.8% after CEA and this was 6.2% after IEA (p < 0.001). If a benign stricture was identified, it was dilated a median of 4 times in the CEA group and only once in the IEA group (p < 0.001). Anastomotic leakage for which reoperation was required occurred in 8.2% after CEA and in 11.4% after IEA (not significant). Median ICU stay, hospital stay, in-hospital mortality, 30-day mortality, and 90-day mortality were similar between the groups (not significant). CONCLUSIONS: MIE with IEA was associated with better functional results than MIE with CEA with less dysphagia, less benign anastomotic strictures requiring fewer dilatations, and a lower incidence of recurrent laryngeal nerve palsy. Other postoperative morbidity and mortality did not differ between the groups.
Assuntos
Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Esôfago/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Cirúrgicos Torácicos/métodos , Anastomose Cirúrgica/métodos , Neoplasias Esofágicas/mortalidade , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Pescoço , Países Baixos/epidemiologia , Estudos Prospectivos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE. METHODS/DESIGN: The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness. DISCUSSION: We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness. TRIAL REGISTRATION: Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.
Assuntos
Anastomose Cirúrgica/métodos , Protocolos Clínicos , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Anastomose Cirúrgica/efeitos adversos , Análise Custo-Benefício , Coleta de Dados , Esofagectomia/efeitos adversos , Humanos , Qualidade de VidaRESUMO
BACKGROUND: Intrathoracic anastomosis after oesophagectomy has recently been associated with reduced functional morbidity compared to a cervical anastomosis. METHODS: From January 2011 until August 2012, all operable patients were scheduled to undergo minimally invasive oesophagectomy (MIE) with intrathoracic anastomosis. Patient characteristics, complications, morbidity and mortality were prospectively registered and analysed. RESULTS: Forty-five patients underwent MIE with intrathoracic stapled end-to-side anastomosis. Major changes in operative technique were made 2 times due to non-satisfactory results, dividing the patients into 3 groups. One patient in group 1 died. The anastomotic leakage rate decreased from 44% in group 1 to 0% in groups 2 and 3 (p = 0.007). The pulmonary complication rate decreased from 67% in group 1 to 44% in group 2 (not significant, NS) and 22% in group 3 (p = 0.04). The median hospital stay decreased from 17 days in group 1 to 14 days in group 2 (NS) and 8 days in group 3 (p < 0.001). There were no stenoses, no dilatations and no patients with recurrent laryngeal nerve palsy. CONCLUSIONS: The introduction of the intrathoracic anastomosis led to favourable functional results but was initially associated with considerable morbidity. RESULTS improved after changing operative techniques, but the learning curve may also be responsible.
Assuntos
Fístula Anastomótica/prevenção & controle , Carcinoma/cirurgia , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Esôfago/cirurgia , Estômago/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anastomose Cirúrgica/efeitos adversos , Anastomose Cirúrgica/métodos , Fístula Anastomótica/etiologia , Conversão para Cirurgia Aberta , Esofagectomia/efeitos adversos , Feminino , Cardiopatias/etiologia , Mortalidade Hospitalar , Humanos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Doenças Pleurais/etiologia , Reoperação , Grampeamento Cirúrgico/efeitos adversos , Grampeamento Cirúrgico/métodos , Toracoscopia/efeitos adversos , Toracoscopia/métodosRESUMO
BACKGROUND: Seroma is a frequent problem after mastectomy (ME) and axillary lymph node dissection (ALND). Seroma is associated with pain, discomfort, impaired mobilisation and repeated aspirations, often resulting in a surgical site infection (SSI). It has already been demonstrated that minimizing dead space through fixation of the skin flaps to the underlying muscles (quilting) lowers the incidence of seroma. The aim of this study was to evaluate the effect of quilting on the incidence of seroma, and SSI. METHODS: Two consecutive groups with a total of 176 patients following ME and/or ALND were retrospectively compared. Endpoints were the incidence of seroma, and number and volume of aspirations and SSIs. Analysed risk factors were age, ME, lymph node dissection, neoadjuvant therapy, body mass index (BMI) and hypertension. RESULTS: The quilted group (n = 89) scored significantly better on all endpoints compared with the conventional group (n = 87). The incidence of seroma decreased from 80.5 % to 22.5 % (p < 0.01), the mean number of aspirations from 4.86 to 2.40 (p = 0.015), the volume of aspirations from 1660 ml to 611 ml (p = 0.05) and the SSIs from 31.0 % to 11.2 % (p < 0.01). Increasing age and lymph node dissection were found to be risk factors for seroma; quilting was a protective factor. CONCLUSION: Quilting is an effective method for preventing seroma and its complications.
Assuntos
Neoplasias da Mama/cirurgia , Excisão de Linfonodo , Mastectomia , Seroma/prevenção & controle , Retalhos Cirúrgicos , Infecção da Ferida Cirúrgica/prevenção & controle , Adesivos Teciduais/uso terapêutico , Axila , Drenagem , Feminino , Seguimentos , Humanos , Incidência , Mamoplastia , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Seroma/etiologia , Técnicas de Sutura , Fatores de TempoRESUMO
Much controversy exists regarding the management of chest tubes following pulmonary lobectomy. The objective of this study was to analyse the effect of a new chest tube management protocol on clinical features, such as postoperative air leak, drain characteristics, 30-day postoperative complications and length of hospital stay. We retrospectively analysed 133 patients who underwent pulmonary lobectomy, from January 2005 to December 2008. A new chest tube protocol was introduced on 1 January 2007 and included placement of a single chest tube and early conversion to water seal. The chest tube was removed when air leak had resolved and (non-chylous) fluid drainage was <400 ml/day. The results of patients in the old (n=68) and the new protocol (n=65) were compared. In the new protocol group the median duration of air leak and duration of chest tube drainage declined significantly. Also the length of hospital stay decreased significantly to a median of eight days. The number of reinterventions and 30-day morbidity and mortality rates did not differ significantly. Our data suggest that placement of a single chest tube and early conversion to water seal decreases the duration of air leak and chest tube drainage and length of hospital stay.