Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 27
Filtrar
1.
Lancet Gastroenterol Hepatol ; 9(10): 924-934, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39151436

RESUMEN

BACKGROUND: Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage. METHODS: This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete. FINDINGS: Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 (2%) people died by 90 days (ten in the FGBA group and eight in the CBA group). INTERPRETATION: ICG NIR fluorescence imaging did not reduce 90-day anastomotic leakage rates in this trial across all types of colorectal surgeries. Further research should be done in subgroups, such as rectosigmoid resections, for which evidence suggests ICG NIR might be beneficial. FUNDING: Olympus Medical, Diagnostic Green, and Intuitive Foundation.


Asunto(s)
Anastomosis Quirúrgica , Fuga Anastomótica , Verde de Indocianina , Humanos , Verde de Indocianina/administración & dosificación , Fuga Anastomótica/prevención & control , Fuga Anastomótica/etiología , Femenino , Masculino , Persona de Mediana Edad , Anciano , Anastomosis Quirúrgica/efectos adversos , Anastomosis Quirúrgica/métodos , Colorantes/administración & dosificación , Imagen Óptica/métodos , Laparoscopía/métodos , Laparoscopía/efectos adversos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Imagen de Perfusión/métodos , Cirugía Colorrectal/efectos adversos , Cirugía Colorrectal/métodos , Países Bajos/epidemiología
2.
Artículo en Inglés | MEDLINE | ID: mdl-39031466

RESUMEN

BACKGROUND: Decision-making after local resection of T1 colorectal cancer (T1CRC) is often complex and calls for optimal information provision as well as active patient involvement. OBJECTIVE: The aim was to evaluate the perceptions of patients with T1CRC on information provision and therapeutic decision-making. METHODS: This multicenter cross-sectional study included patients who underwent endoscopic or local surgical resection as initial treatment. Information provision was assessed using the EORTC QLQ-INFO25 questionnaire. In patients with high-risk T1CRC, we evaluated decisional involvement and satisfaction regarding the choice as to whether to undergo additional treatment after local resection, and the level of decisional conflict using the Decisional Conflict Scale. RESULTS: Ninety-eight patients with T1CRC were included (72% response rate; 79/98 endoscopic and 19/98 local surgical resection; 45/98 high-risk T1CRC). Median time since local resection was 28 months (IQR 18); none had developed recurrence. Unmet information needs were reported by 29 patients (30%; 18 low-risk, 11 high-risk), mostly on post-treatment related topics (follow-up visits, recovery time, recurrence prevention). After local resection, 24 of the 45 high-risk patients (53%) underwent additional treatment, while others were subjected to surveillance. Higher-educated patients were more often actively involved in decision-making (93% vs. 43%, p = 0.002) and more frequently underwent additional treatment (79% vs. 40%, p = 0.02). Decisional conflict (p = 0.19) and satisfaction (p = 0.78) were comparable between higher- and lower-educated high-risk patients. CONCLUSION: Greater attention should be given to the post-treatment course during consultations following local T1CRC resection. The differences in decisional involvement and selected management strategies between higher- and lower-educated high-risk patients warrant further investigation.

3.
Cancers (Basel) ; 15(18)2023 Sep 09.
Artículo en Inglés | MEDLINE | ID: mdl-37760458

RESUMEN

T1 colorectal cancers (T1CRC) are increasingly being treated by endoscopic submucosal dissection (ESD). After ESD of a T1CRC, completion surgery is indicated in a subgroup of patients. Currently, the influence of ESD on surgical morbidity and mortality is unknown. The aim of this study was to compare 90-day morbidity and mortality of completion surgery after ESD to primary surgery. The completion surgery group consisted of suspected T1CRC patients from a multicenter prospective ESD database (2014-2020). The primary surgery group consisted of pT1CRC patients from a nationwide surgical registry (2017-2019). Patients with rectal or sigmoidal cancers were selected. Patients receiving neoadjuvant therapy were excluded. Propensity score adjustment was used to correct for confounders. In total, 411 patients were included: 54 in the completion surgery group (39 pT1, 15 pT2) and 357 in the primary surgery group with pT1CRC. Adverse event rate was 24.1% after completion surgery and 21.3% after primary surgery. After completion surgery 90-day mortality did not occur, though one patient died in the primary surgery group. After propensity score adjustment, lymph node yield did not differ significantly between the groups. Among other morbidity-related outcomes, stoma rate (OR 1.298 95%-CI 0.587-2.872, p = 0.519) and adverse event rate (OR 1.162; 95%-CI 0.570-2.370, p = 0.679) also did not differ significantly. A subgroup analysis was performed in patients undergoing rectal surgery. In this subgroup (37 completion and 136 primary surgery), these morbidity outcomes also did not differ significantly. In conclusion, this study suggests that ESD does not compromise morbidity or 90-day mortality of completion surgery.

5.
Ann Surg Oncol ; 30(9): 5472-5485, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37340200

RESUMEN

BACKGROUND: Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level. METHODS: Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (≥7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those  undergoing only rectal resection. RESULTS: Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874). CONCLUSION: Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research.


Asunto(s)
Escisión del Ganglio Linfático , Neoplasias del Recto , Humanos , Escisión del Ganglio Linfático/métodos , Estudios Transversales , Ganglios Linfáticos/cirugía , Ganglios Linfáticos/patología , Neoplasias del Recto/patología , Recto/patología , Estudios Retrospectivos , Recurrencia Local de Neoplasia/cirugía , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias
6.
Lancet Haematol ; 10(4): e250-e260, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36863386

RESUMEN

BACKGROUND: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. METHODS: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. FINDINGS: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202). INTERPRETATION: Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation. FUNDING: Vifor Pharma.


Asunto(s)
Anemia Ferropénica , Neoplasias Colorrectales , Adulto , Masculino , Humanos , Femenino , Hierro , Anemia Ferropénica/etiología , Anemia Ferropénica/complicaciones , Hemoglobinas , Suplementos Dietéticos , Neoplasias Colorrectales/complicaciones , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/cirugía
7.
Dis Colon Rectum ; 66(6): 774-784, 2023 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-35522731

RESUMEN

BACKGROUND: The role of laparoscopy for emergency resection of left-sided obstructive colon cancer remains unclear, especially regarding impact on survival. OBJECTIVE: This study aimed to determine short- and long-term outcomes after laparoscopic versus open emergency resection of left-sided obstructive colon cancer. DESIGN: This observational cohort study compared patients who underwent laparoscopic emergency resection to those who underwent open emergency resection between 2009 and 2016 by using 1:3 propensity-score matching. Matching variables included sex, age, BMI, ASA score, previous abdominal surgery, tumor location, cT4, cM1, multivisceral resection, small-bowel distention on CT, and subtotal colectomy. SETTING: This was a nationwide, population-based study. PATIENTS: Of 2002 eligible patients with left-sided obstructive colon cancer, 158 patients who underwent laparoscopic emergency resection were matched with 474 patients who underwent open emergency resection. INTERVENTIONS: The intervention was laparoscopic versus open emergency resection. MAIN OUTCOME MEASURES: The main outcome measures were 90-day mortality, 90-day complications, permanent stoma, disease recurrence, overall survival, and disease-free survival. RESULTS: Intentional laparoscopy resulted in significantly fewer 90-day complications (26.6% vs 38.4%; conditional OR, 0.59; 95% CI, 0.39-0.87) and similar 90-day mortality. Laparoscopy resulted in better 3-year overall survival (81.0% vs 69.4%; HR, 0.54; 95% CI, 0.37-0.79) and disease-free survival (68.3% vs 52.3%; HR, 0.64; 95% CI, 0.47-0.87). Multivariable regression analyses of the unmatched 2002 patients confirmed an independent association of laparoscopy with fewer 90-day complications and better 3-year survival. LIMITATIONS: Selection bias was the limitation that cannot be completely ruled out because of the retrospective nature of this study. CONCLUSIONS: This population-based study with propensity score-matched analysis suggests that intentional laparoscopic emergency resection might improve outcomes in patients with left-sided obstructive colon cancer compared to open emergency resection. Management of those patients in the emergency setting requires proper selection for intentional laparoscopic resection if relevant expertise is available, thereby considering other alternatives to avoid open emergency resection (ie, decompressing stoma). See Video Abstract at http://links.lww.com/DCR/B972 . RESULTADOS A CORTO Y LARGO PLAZO DESPUS DE LA RESECCIN LAPAROSCPICA DE EMERGENCIA EN CNCER DE COLON IZQUIERDO OBSTRUCTIVO UN ANLISIS EMPAREJADO POR PUNTAJE DE PROPENSIN A NIVEL NACIONAL: ANTECEDENTES:El papel de la laparoscopia en la resección de emergencia en cáncer de colon izquierdo obstructivo sigue sin estar claro, especialmente con respecto al impacto en la supervivencia.OBJETIVO:El objetivo de este estudio fue determinar los resultados a corto y largo plazo después de la resección de emergencia laparoscópica versus abierta en cáncer de colon izquierdo obstructivo.DISEÑO:Estudio observacional de cohortes comparó pacientes que se sometieron a resección de laparoscópica de emergencia versus resección abierta de emergencia entre 2009 y 2016, mediante el uso de emparejamineto por puntaje de propensión 1: 3. Las variables emparejadas incluyeron sexo, edad, IMC, puntaje ASA, cirugía abdominal previa, ubicación del tumor, cT4, cM1, resección multivisceral, distensión del intestino delgado en la TAC y colectomía subtotal.ENTORNO CLINICO:A nivel nacional, basado en la población.PACIENTES:De 2002 pacientes elegibles con cáncer de colon izquierdo obstructivo, 158 pacientes con resección laparoscópica s de emergencia e emparejaron con 474 pacientes con resección abierta de emergencia.INTERVENCIONES:Resección laparoscópica de emergencia versus abierta.PRINCIPALES MEDIDAS DE RESULTADO:Las medidas primarias fueron la mortalidad a 90 días, complicaciones a 90 días, estoma permanente, recurrencia de la enfermedad, supervivencia general y supervivencia libre de enfermedad.RESULTADOS:La laparoscopia intencional dió como resultado significativamente menos complicaciones a los 90 días (26,6 % vs 38,4 %, cOR 0,59, IC del 95 %: 0,39-0,87) y una mortalidad similar a los 90 días. La laparoscopia resultó en una mejor supervivencia general a los 3 años (81,0 % vs 69,4 %, HR 0,54, IC del 95 % 0,37-0,79) y supervivencia libre de enfermedad (68,3 % vs 52,3 %, HR 0,64, IC del 95 % 0,47-0,87). Los análisis de regresión multivariable de los 2002 pacientes no emparejados confirmaron una asociación independiente de la laparoscopia con menos complicaciones a los 90 días y una mejor supervivencia a los 3 años.LIMITACIONES:El sesgo de selección no se puede descartar por completo debido a la naturaleza retrospectiva de este estudio.CONCLUSIONES:Estudio poblacional con análisis emparejado por puntaje de propensión sugiere que la resección laparoscópica de emergencia intencional podría mejorar los resultados a corto y largo plazo en pacientes con cáncer de colon izquierdo obstructivo en comparación con resección abierta de emergencia, lo que justifica la confirmación en estudios futuros. El manejo de esos pacientes en el entorno de emergencia requiere una selección adecuada para la resección laparoscópica intencional si se dispone de experiencia relevante, considerando así otras alternativas para evitar la resección abierta de emergencia (es decir, ostomia descompresiva). Consulte Video Resumen en http://links.lww.com/DCR/B972 . (Traducción- Dr. Francisco M. Abarca-Rendon & Dr. Fidel Ruiz Healy).


Asunto(s)
Neoplasias del Colon , Laparoscopía , Humanos , Estudios Retrospectivos , Puntaje de Propensión , Recurrencia Local de Neoplasia/cirugía , Neoplasias del Colon/cirugía , Laparoscopía/métodos
8.
World J Gastrointest Surg ; 14(6): 556-566, 2022 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-35979424

RESUMEN

BACKGROUND: Closed-loop small bowel obstruction (CL-SBO) can threaten the viability of the intestine by obstructing a bowel segment at two adjacent points. Prompt recognition and surgery are crucial. AIM: To analyze the outcomes of patients who underwent surgery for CL-SBO and to evaluate clinical predictors. METHODS: Patients who underwent surgery for suspected CL-BSO on computed tomography (CT) at a single center between 2013 and 2019 were evaluated retrospectively. Patients were divided into three groups by perioperative outcome, including viable bowel, reversible ischemia, and irreversible ischemia. Clinical and laboratorial variables at presentation were compared and postoperative outcomes were analyzed. RESULTS: Of 148 patients with CL-SBO, 28 (19%) had a perioperative viable small bowel, 86 (58%) had reversible ischemia, and 34 (23%) had irreversible ischemia. Patients with a higher age had higher risk for perioperative irreversible ischemia [odds ratio (OR): 1.03, 95% confidence interval (CI): 0.99-1.06]. Patients with American Society of Anaesthesiologists (ASA) classification ≥ 3 had higher risk of perioperative irreversible ischemia compared to lower ASA classifications (OR: 3.76, 95%CI: 1.31-10.81). Eighty-six patients (58%) did not have elevated C-reactive protein (> 10 mg/L), and between-group differences were insignificant. Postoperative in-hospital stay was significantly longer for patients with irreversible ischemia (median 8 d, P = 0.001) than for those with reversible ischemia (median 6 d) or a viable bowel (median 5 d). Postoperative morbidity was significantly higher in patients with perioperative irreversible ischemia (45%, P = 0.043) compared with reversible ischemia (20%) and viable bowel (4%). CONCLUSION: Older patients or those with higher ASA classification had an increased risk of irreversible ischemia in case of CL-SBO. After irreversible ischemia, postoperative morbidity was increased.

9.
Eur J Radiol ; 142: 109844, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34252868

RESUMEN

PURPOSE: To correlate CT-findings in patients with closed-loop small bowel obstruction (CL-SBO) with perioperative findings, to identify patients who require immediate surgical intervention. Secondary purpose was to substantiate the role of radiologists in predicting perioperative outcome. METHODS: Data were retrospectively obtained from patients with surgically confirmed CL-SBO, between September 2013 and September 2019. Three radiologists reviewed CTs to assess defined CT features and predict patient outcome for bowel wall ischemia and necrosis using a likelihood score. Univariate statistical analyses were performed and diagnostic performance parameters and interobserver agreement were assessed for each feature. RESULTS: Of 148 included patients, 28 (19%) intraoperatively had viable bowel and 120 (81%) had bowel wall ischemia or necrosis. Most CT characteristics, as well as the likelihood of ischemia and necrosis, found fair or moderate multirater agreement. Increased attenuation of bowel wall and mesenteric vessels on non-contrast-enhanced CT had a specificity for bowel ischemia or necrosis of 100% (sensitivity respectively 48% (p < 0.001) and 21% (p = 0.09)). Mesenteric edema had high sensitivity for ischemia or necrosis (90%), but specificity of only 26% (p < 0.001). For mesenteric fluid, sensitivity was 60% and specificity 57% (p = 0.004). Decreased enhancement of bowel wall in both arterial and PV-phase showed significant correlation, respectively a sensitivity of 58% and 42%, and specificity of 88% and 79% (both p < 0.001). Likelihood of both ischemia and necrosis were significantly correlated with perioperative outcome (p < 0.001). CONCLUSION: CT findings concerning mesenteric and bowel wall changes, as well as radiologists' judgement of likelihood of ischemia and necrosis are significantly correlated with perioperative outcome of bowel wall ischemia and necrosis in patients with CL-SBO.


Asunto(s)
Obstrucción Intestinal , Isquemia Mesentérica , Humanos , Obstrucción Intestinal/diagnóstico por imagen , Obstrucción Intestinal/cirugía , Intestino Delgado/diagnóstico por imagen , Intestino Delgado/cirugía , Estudios Retrospectivos , Sensibilidad y Especificidad , Tomografía Computarizada por Rayos X
10.
BMJ Case Rep ; 14(3)2021 Mar 18.
Artículo en Inglés | MEDLINE | ID: mdl-33737278

RESUMEN

Vaginal evisceration is a rare but severe complication after hysterectomy or colpotomy and is generally successfully repaired by reapproximating healthy tissue edges of the vagina. Recurrent vaginal cuff dehiscence is problematic especially in sexually active women. We describe two cases of recurrent vaginal cuff dehiscence. The first patient had a hysterectomy for endometriosis. The second patient underwent laparoscopic excision of an endometriotic nodule at the vaginal vault. The vaginal cuff dehiscence was repaired by a laparoscopic approach employing an omental flap to enhance tissue healing. This closure technique turned out to be successful at follow-up in both cases. In case of recurrent vaginal cuff dehiscence, management options are limited. Our case report offers a laparoscopic treatment option by using an omental flap. This procedure can be used when conventional repair fails.


Asunto(s)
Endometriosis , Laparoscopía , Endometriosis/cirugía , Femenino , Humanos , Histerectomía/efectos adversos , Dehiscencia de la Herida Operatoria/etiología , Dehiscencia de la Herida Operatoria/cirugía , Vagina/cirugía
11.
BMC Gastroenterol ; 20(1): 225, 2020 Jul 13.
Artículo en Inglés | MEDLINE | ID: mdl-32660488

RESUMEN

BACKGROUND: In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden. METHODS: Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior. DISCUSSION: This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future. TRIAL REGISTRATION: Netherlands Trial Register, NL7083 , 06 July 2018.


Asunto(s)
Neoplasias Colorrectales , Resección Endoscópica de la Mucosa , Neoplasias del Recto , Cirugía Endoscópica Transanal , Resección Endoscópica de la Mucosa/efectos adversos , Europa (Continente) , Humanos , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia , Países Bajos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias del Recto/cirugía , Cirugía Endoscópica Transanal/efectos adversos , Resultado del Tratamiento
12.
Eur J Surg Oncol ; 46(6): 1144-1150, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32178963

RESUMEN

BACKGROUND: Comparing outcomes across hospitals to learn from best performing hospitals can be valuable. However, reliably identifying best performance is challenging. This study assesses the possibility to distinguish best performing hospitals on single outcomes and consistency of performance on different outcomes. METHODS: Data were derived from the Dutch ColoRectal Audit 2013-2015. Outcomes considered were textbook outcome (colon), (circumferential) resection margins, (serious) complications, mortality, and 'failure to rescue'. To include uncertainty in rankings, random effect logistic regression models were used to calculate expected ranks (ERs), for each hospital and outcome. Rankability was calculated for each outcome, as a measure of reliability of ranking. Furthermore, correlation between ERs on different outcomes was assessed. Correlation was considered weak <0.40, moderate between 0.40 - 0.59 and strong >0.60. RESULTS: The study included 32 143 patients; of whom 11 373 were treated in 2015 across 84 hospitals, 8181 colon and 3192 rectal cancer patients. In this one-year period 'Postoperative complications' had the highest rankability for colon (57%) and rectal (41%) surgery. No (group of) hospital(s) had the highest ER(s) on all outcomes. Correlation between ERs of outcomes was moderate in 2 (of 25) and strong in 4 (of 25) combinations. Rankability of colorectal mortality increased from 14% in 2015 to 35% when data over 2013-2015 were used. CONCLUSION: The highest reliability of identifying best performance based on an outcome was 57%. However, the balance between reliability and relevance of outcomes is vulnerable. No (group of) hospital(s) could be identified as best performer on all outcomes. Performance was not consistent on outcomes.


Asunto(s)
Neoplasias Colorrectales/terapia , Hospitales/normas , Complicaciones Posoperatorias/epidemiología , Indicadores de Calidad de la Atención de Salud , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria/tendencias , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Reproducibilidad de los Resultados , Estudios Retrospectivos
13.
Acta Chir Belg ; 119(2): 132-136, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30332334

RESUMEN

BACKGROUND: Low Hartmann's procedure (LHP) and intersphincteric abdominoperineal resection (iAPR) are both surgical options in the treatment of distal rectal cancer when there is no intention to restore bowel continuity. This study aimed to evaluate current practice among members of the Dutch Association of Coloproctology (WCP). METHODS: An online survey among members of the WCP who represent 66 Dutch hospitals was conducted. The survey consisted of 15 questions addressing indications for surgical procedures and complications. RESULTS: Surgeons from 37 hospitals (56%) responded. Thirty-six percent does not distinguish low from high Hartmann's procedures based on estimated length of the rectal remnant. Overall, iAPR was the preferred technique in 86%. If asking whether operative approach would be different in tumours at 1 cm from the pelvic floor compared to 5 cm distance, 62% stated that they would consider a different technique. The incidence of pelvic abscess after LHP was thought to be higher, equal or lower than iAPR in 36%, 36% and 21%, respectively, with the remaining respondents not answering this question. CONCLUSIONS: The vast majority of the respondents considers iAPR as the preferred non-restorative procedure for rectal cancer not invading the sphincter complex, which contradicts with population based data from 2011.


Asunto(s)
Colectomía/estadística & datos numéricos , Proctectomía/estadística & datos numéricos , Neoplasias del Recto/epidemiología , Neoplasias del Recto/cirugía , Canal Anal/cirugía , Encuestas de Atención de la Salud , Humanos , Internet , Países Bajos/epidemiología , Pautas de la Práctica en Medicina/estadística & datos numéricos
14.
Dis Colon Rectum ; 61(8): 988-998, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29944585

RESUMEN

BACKGROUND: When a colorectal or coloanal anastomosis fails because of persistent leakage or stenosis, or the anastomosis has to be resected for recurrent cancer, constructing a new anastomosis might be an option in selected patients. This is a rare and complex type of redo surgery. OBJECTIVE: The aim of this review was to evaluate the current literature on redo anastomosis for complicated colorectal or coloanal anastomosis. DATA SOURCES: A systematic literature search of MEDLINE, EMBASE, the Cochrane Library, the PROSPERO register, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform database was performed. STUDY SELECTION: Two reviewers independently screened the available literature. All studies reporting on redo surgery and aiming at reconstruction of a prior low colorectal or coloanal anastomosis for any indication were included. MAIN OUTCOME MEASURES: Primary outcome was successful restoration of continuity. Secondary outcomes were postoperative morbidity, pelvic sepsis, incontinence, and mortality. RESULTS: Nine studies were included, comprising 291 patients, of whom 76% had index surgery for colorectal cancer. Pooled proportions showed an overall success rate of 79% (95% CI, 69-86), with a pooled incidence of major postoperative morbidity of 16% (95% CI, 10-24). The pooled pelvic sepsis rate was 16% (95% CI, 9-27), and the pooled surgical reintervention and readmission rates were 11% (95% CI, 8-17) and 7% (95% CI, 3-15). Five studies reported on incontinence, with a pooled proportion of 17% (95% CI, 10-26). LIMITATIONS: The limitations of this review are the lack of randomized controlled trials and high-quality studies, and the small sample sizes and heterogeneous patient populations in the included studies. CONCLUSIONS: Redo surgery is a valuable treatment option for the complicated colorectal or coloanal anastomosis with 79% successful restoration of bowel continuity in the published literature from experienced tertiary centers.


Asunto(s)
Anastomosis Quirúrgica/efectos adversos , Colectomía/efectos adversos , Colon/cirugía , Neoplasias Colorrectales/cirugía , Complicaciones Posoperatorias/cirugía , Anastomosis Quirúrgica/métodos , Colectomía/métodos , Humanos , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento
15.
Int J Colorectal Dis ; 32(11): 1583-1589, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28801697

RESUMEN

PURPOSE: Two non-restorative options for low rectal cancer not invading the sphincter are the low Hartmann's procedure (LH) or intersphincteric proctectomy (IP). The aim of this study was to compare postoperative morbidity with emphasis on pelvic abscesses after LH and IP. METHODS: All patients that had LH or IP for low rectal cancer were included in three centres between 2008 and 2014 in this retrospective cohort study. Follow-up was performed for at least 12 months. RESULTS: A total of 52 patients were included: 40 LH and 12 IP. Median follow-up was 29 months (IQR 23). There were no differences between groups in gender, age and ASA classification. Seven patients in the LH group (18%) and four patients in the IP group (33%) developed a complication within 30-day postoperative with a Clavien-Dindo classification grade III or higher (P = 0.253). Four out of 40 patients (10%) in the LH group and two out of 12 patients (17%) in the IP group developed a pelvic abscess (P = 0.612). Reinterventions were performed in 11 (28%) patients in the LH group and five (42%) patients in the IP group (P = 0.478), with a total number of reinterventions of 13 and 20, respectively. Six and 15 interventions were related to pelvic abscesses, respectively. CONCLUSION: Pelvic abscesses seem to occur in a similar rate after both LH and IP. Previous reports from the literature suggesting that IP might be associated with less infectious pelvic complications compared to LH are not supported by this study, although numbers are small.


Asunto(s)
Absceso , Canal Anal , Colectomía , Colostomía , Infección Pélvica , Neoplasias del Recto , Recto , Absceso/diagnóstico , Absceso/etiología , Absceso/cirugía , Adulto , Anciano , Canal Anal/patología , Canal Anal/cirugía , Colectomía/efectos adversos , Colectomía/métodos , Colostomía/efectos adversos , Colostomía/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infección Pélvica/diagnóstico , Infección Pélvica/etiología , Infección Pélvica/cirugía , Infección Pélvica/terapia , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Neoplasias del Recto/patología , Neoplasias del Recto/cirugía , Recto/patología , Recto/cirugía , Reoperación/métodos , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Resultado del Tratamiento
17.
Cancer Immunol Immunother ; 57(12): 1837-47, 2008 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18398607

RESUMEN

BACKGROUND: To compare immune responses following neoadjuvant chemoradiation therapy in combination with hyperthermia plus surgery to those induced by surgery alone in patients with oesophageal cancer. METHODS: Thirty-two patients with histopathologically proven oesophageal cancer, scheduled for potentially curative transhiatal or transthoracic oesophagectomy with (neo, n = 20) or without (control, n = 12) neoadjuvant thermochemoradiation therapy (ThCR) were included. Peripheral blood samples were obtained before ThCR, after 2 weeks of ThCR, 1 day before surgery, on postoperative days 1, 3, 7, and 6 weeks after surgery, for white blood cell counts, lymphocyte subsets and T helper type 1 (Th1) and type 2 (Th2) lymphocyte responses. RESULTS: Neo patients showed a significant decrease in granulocytes and lymphocyte subsets, and T cell cytokines after 2 weeks of ThCR. Only CD8+ (cytotoxic) T cells recovered after ThCR to reach normal levels prior to surgery. In contrast, CD4+ T (helper) cells, and NK- and B cells in neo patients did not recover prior to surgery (all P < 0.05). Oesophagectomy induced a significant increase in granulocytes and a decrease in lymphocytes (and subsets). Only those subsets that had not recovered after ThCR (CD4+ T cells, NK and B cells but not CD8+ T cells), were significantly lower (all P < 0.05) during the entire postoperative study period. Postoperatively, the stimulated cytokine production capacity of Th1 and Th2 cells, corrected for number of T cells, was not significantly different between the groups. CONCLUSION: Neoadjuvant thermochemoradiation for oesophageal cancer caused significant disturbances of host cellular immunity with reduced T, NK and B cell counts, and differential recovery of cytotoxic and helper T cells leading to prolonged T cell imbalance that extends beyond the time of surgery. The functional and anti-tumour consequences of this immunodisturbance need further investigation, as recovery of T helper cytokine production towards surgery was less impaired than T helper cell counts.


Asunto(s)
Neoplasias Esofágicas/inmunología , Neoplasias Esofágicas/terapia , Esofagectomía , Terapia Neoadyuvante , Adulto , Anciano , Antineoplásicos/administración & dosificación , Linfocitos B/efectos de los fármacos , Linfocitos B/efectos de la radiación , Terapia Combinada , Femenino , Granulocitos/efectos de los fármacos , Granulocitos/efectos de la radiación , Humanos , Células Asesinas Naturales/efectos de los fármacos , Células Asesinas Naturales/efectos de la radiación , Recuento de Leucocitos , Masculino , Persona de Mediana Edad , Radioterapia , Subgrupos de Linfocitos T/efectos de los fármacos , Subgrupos de Linfocitos T/efectos de la radiación , Células TH1/efectos de los fármacos , Células TH1/efectos de la radiación , Células Th2/efectos de los fármacos , Células Th2/efectos de la radiación
18.
J Cancer Res Clin Oncol ; 134(2): 227-36, 2008 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-17653575

RESUMEN

PURPOSE: Variable uptake of 18FDG has been noticed in positron emission tomography (PET) studies of patients with oesophageal adenocarcinoma. The aim of the present study was to investigate biological parameters involved in 18FDG uptake in oesophageal adenocarcinoma for selection of patients with increased 18FDG uptake and prediction of prognostic value of 18FDG PET. PATIENTS AND METHODS: Preoperative PET scans were performed in 26 patients with histologically proven oesophageal adenocarcinoma. 18FDG uptake was semiquantitatively measured by SUV(BSAg. )Tumour sections were stained by immunohistochemistry for angiogenic markers (VEGF, CD31), glucose transporter-1 (Glut-1), hexokinase (HK) isoforms, for proliferation marker (Ki67), for macrophage marker (CD68) and for apoptosis marker (cleaved caspase-3). Cell densities, differentiation grade, degree of necrosis and mucus, T-stage and tumour size were assessed. In addition follow-up was analysed. RESULTS: No association was found between 18FDG uptake and angiogenic markers. In contrast, a significant correlation was found between 18FDG uptake and Glut-1 expression. No correlations were found between 18FDG uptake and HK isoforms, Ki67 or cleaved caspase-3. Also, no correlations were found between 18FDG uptake and cell density, differentiation grade, CD68, mucus and necrosis. However, there was a significant correlation between 18FDG uptake and tumour size and between 18FDG uptake and tumour recurrence. CONCLUSIONS: Glut-1 expression and tumour size seem parameters associated with 18FDG uptake in patients with biopsy proven oesophageal adenocarcinoma, and may be used to select oesophageal cancer patients in whom 18FDG-PET is of diagnostic value and may predict disease outcome.


Asunto(s)
Adenocarcinoma/metabolismo , Neoplasias Esofágicas/metabolismo , Fluorodesoxiglucosa F18/farmacocinética , Radiofármacos/farmacocinética , Adenocarcinoma/secundario , Anciano , Biomarcadores de Tumor/metabolismo , Neoplasias Esofágicas/patología , Esofagectomía , Unión Esofagogástrica/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Técnicas para Inmunoenzimas , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico , Tomografía de Emisión de Positrones , Cuidados Preoperatorios , Análisis de Matrices Tisulares , Distribución Tisular , Resultado del Tratamiento
19.
Patient Prefer Adherence ; 2: 157-62, 2008 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-19920957

RESUMEN

OBJECTIVE: Defining an optimal staging strategy requires an evaluation of the effectiveness and costs of diagnostic tests and may include the burden of these tests for patients. This study evaluated the burden of cervical ultrasonography (US), endoscopic ultrasonography (EUS), computed tomography (CT) and positron emission tomography (PET) in patients with esophageal carcinoma (EC). METHODS: Consenting consecutive patients underwent a standard preoperative work-up. Burden of testing was evaluated with a self-report questionnaire addressing anxiety, embarrassment, and discomfort, each measured on a 1(none) to 5 (extreme) point-scale. An overall burden score was calculated by summing the three item scores. In addition, patients were asked to rank the four tests from least to most inconvenient. Statistical analysis was performed with nonparametric tests. RESULTS: 82 patients (67 , 15 ; mean age 64.3 yrs) participated. For most tests and most dimensions of burden, the large majority of subjects was in categories 1 and 2.With respect to anxiety, the rank order (from highest burden to lowest burden) was EUS, US, PET, and CT (average scores 1.7, 1.5, 1.4, and 1.2, respectively). For embarrassment, the rank order was EUS, PET, US, and CT (1.9, 1.5, 1.4, and 1.3 respectively). For discomfort, the rank order was EUS, PET, US and CT (2.0, 1.6, 1.4, and 1.2, respectively). And for total burden, the rank order was EUS, PET, US and CT (5.6, 4.6, 4.2, and 3.7). PET was ranked as least inconvenient by 35% of patients and as most inconvenient by 16% compared with the other tests. CONCLUSION: Significant but small differences were observed in patient burden for imaging tests to evaluate EC. The perceived burden of PET was lower than that of EUS, but higher than the burden of CT. However absolute values were low for all tests and therefore patient burden will not be a key feature for the construction of an optimal staging algorithm for EC.

20.
Eur J Nucl Med Mol Imaging ; 34(3): 392-404, 2007 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-17033848

RESUMEN

PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of different scanners, image reconstruction and data analysis software. In this study we evaluated whether SUVs, obtained at three different institutes, may be directly compared after calibration and correction for inter-institute differences. METHODS: First, an anthropomorphic thorax phantom containing variously sized spheres and activities, simulating tumours, was scanned and processed in each institute to evaluate differences in scanner calibration. Secondly, effects of image reconstruction and ROI method on recovery coefficients were studied. Next, SUVs were derived for tumours in 23 subjects. Of these 23 patients, four and ten were scanned in two institutes on an HR+ PET scanner and nine were scanned in one institute on an ECAT EXACT PET scanner. All phantom and clinical data were reconstructed using iterative reconstruction with various iterations, with both measured (MAC) and segmented attenuation correction (SAC) and at various image resolutions. Activity concentrations (AC) or SUVs were derived using various ROI isocontours. RESULTS: Phantom data revealed differences in SUV quantification of up to 30%. After application-specific calibration, recovery coefficients obtained in each institute were equal to within 15%. Varying the ROI isocontour value resulted in a predictable change in SUV (or AC) for both phantom and clinical data. Variation of image resolution resulted in a predictable change in SUV quantification for large spheres/tumours (>5 cc) only. For smaller tumours (<2 cc), differences of up to 40% were found between high (7 mm) and low (10 mm) resolution images. Similar differences occurred when data were reconstructed with a small number of iterations. Finally, no significant differences between MAC and SAC reconstructed data were observed, except for tumours near the diaphragm. CONCLUSION: Standardisation of acquisition, reconstruction and ROI methods is preferred for SUV quantification in multi-centre trials. Small unavoidable differences in methodology can be accommodated by performing a phantom study to assess inter-institute correction factors.


Asunto(s)
Algoritmos , Fluorodesoxiglucosa F18/farmacocinética , Aumento de la Imagen/normas , Interpretación de Imagen Asistida por Computador/normas , Estudios Multicéntricos como Asunto/normas , Tomografía de Emisión de Positrones/normas , Humanos , Aumento de la Imagen/métodos , Interpretación de Imagen Asistida por Computador/métodos , Países Bajos , Radiofármacos , Estándares de Referencia , Reproducibilidad de los Resultados , Sensibilidad y Especificidad
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA