Μελέτη των παραγόντων μικροκυκλοφορίας – ισχαιμίας σε ισχαιμούντα κάτω άκρα σε άτομα με διαβητική μικροαγγειοπάθεια, με τη μέθοδο της μικροδιάλυσης (καθορισμός του επιπέδου ακρωτηριασμού με βάση τη μικροκυκλοφορία)

Εισαγωγή: Η ισχαιμία των κάτω άκρων που παρατηρείται σε διαβητικούς ασθενείς είναι αποτέλεσμα των διαταραχών που συμβαίνουν στην μακρο και μικροκυκλοφορία. Στην παρούσα μελέτη χρησιμοποιήσαμε την τεχνική της μικροδιάλυσης για να αξιολογήσουμε την επάρκεια της μικροκυκλοφορίας με σκοπό να μπορέσουμε να προκαθορίσουμε προεγχειρητικά το επίπεδο του ακρωτηριασμού του σκέλους. Δεδομένα: Οι διαβητικοι ασθενείς που υποβάλονται σε ακρωτηριασμό κάτω άκρου εξαιτίας διαβητικής αγγειοπάθειας, εμφανίζουν υψηλά ποσοστά νοσηρότητας και θνησιμότητας. Η απόφαση για το επίπεδο του ακρωτηριασμού είναι ιδιαίτερα κρίσιμη. Οι παρούσες τεχνικές αξιολόγησης δεν είναι ιδανικές για τον προκαθορισμό του ιδανικού επιπέδου ακρωτηριασμού αφού δεν αξιολογούν ικανοποιητικά τη μικροκυκλοφορία στο πάσχον άκρο. Μέθοδος: Στη παρούσα μελέτη συμμετείχαν 165 διαβητικοί ασθενείς οι οποίοι ακρωτηριάστηκαν εξαιτίας ισχαιμίας κάτω άκρου. Ο καθετήρας μικροδιάλυσης τοποθετήθηκε προεγχειρητικά στο επίπεδο του προγραμματισμένου κρημνού που θα χρησιμοποιούνται για τη δημιουργία του χειρουργικού κολοβώματος. Ακολούθως ακολουθούσε η συλλογή δεδομένων ιστικής βιοχημείας για 24 ώρες. Τα δεδομένα αυτά αφορούσαν τη συγκέντρωση γλυκόζης, γλυκερόλης, γαλακτικού και πυροσταφυλικού οξέος στο διάμεσο ιστό. Ακολούθως οι ασθενείς ακρωτηριάζονταν και αξιολογούνταν η κλινική έκβαση του ακρωτηριασμού. Αποτελέσματα: Οι ασθενείς της μελέτης χωρίστηκαν σε 2 ομάδες μετεγχειρητικά ανάλογα με την έκβαση του ακρωτηριασμού (επιτυχής ή αποτυχής). Δεν υπήρχε στατιστικά σημαντική διαφορά μεταξύ των 2 ομάδων σχετικά με το φύλο, ASA, BMI, την ύπαρξη διαφόρων νοσηροτήτων, τη διαγνωστική μέθοδο που χρησιμοποιήθηκε για τον καθορισμό του επιπέδου του ακρωτηριασμού και του επιπέδου του ακρωτηριασμού. Επίσης δεν υπήρχε διαφορά ούτε στις συγκεντώσεις γλυκόζης, γλυκερόλης και πυροσταφυλικού οξέος στο διάμεσο ιστό, μεταξύ των δύο ομάδων. Η τοπική συγκέντρωση γαλακτικού οξέος ήταν σημαντικά διαφορετική μεταξύ των δύο ομάδων και ο λόγος του γαλακτικού / πυροσταφυλικού οξέος σχετίστηκε ως ανεξάρτητος παράγοντας κυνδίνου για την κλινική έκβαση του ακρωτηριασμού. Συμπέρασμα: Τα αποτελέσματα της μελέτης μας υποδηλώνουν ότι η αυξημένη συγκέντρωση προεγχειρητικά του λόγου της συγκέντρωσης γαλακτικού / πυροσταφυλικού οξέος στο υπό μέλετη επίπεδο ακρωτηριασμού, σχετίζεται με αυξημένη πιθανότητα αποτυχίας και ως εκ τούτου η προεγχειρητική χρήση του λόγου αυτού μπορεί να χρησιμοποιηθεί με υψηλό ποσοστό ευαισθησίας και ειδικότητας ως προγνωστικός παράγοντας για την κλινική έκβαση των ακρωτηριασμών σε διαβητικούς ασθενείς.Introduction: Leg ischaemia in diabetic patients is a result of macro and microcirculation problems. We used microdialysis technique to monitor tissue microcirculation and extracellular biochemistry in order to predict the outcome of amputation. Background Data: Diabetic patients with ischaemic leg undergoing limb amputation carry high mortality and morbidity rates. Decision making for the level of amputation is critical. Current diagnostic techniques cannot be used as optimal prognostic factor for the level or the success of the amputation due to inadequate evaluation of leg microcirculation. Methods: 165 diabetic patients who underwent limb amputation for leg ischaemia were enrolled. A microdialysis catheter was placed preoperatively to the level of the intended flap for the stump reconstruction. Data were collected for 24 hours and were analysed for the levels of glucose, glycerol, lactate and pyruvate. Patients were then amputated and monitored regarding the clinical outcome of the amputations. Results: Patients were divided into two groups according to success of amputation. There was no difference between the two groups regarding gender, ASA, BMI, co-morbidities, diagnostic modality used, level of amputation, as well as in glucose, glycerol, and pyruvate levels. However, local concentrations of lactate were significantly different between the two groups and lactate/pyruvate (L/P) ratio was strongly associated as a risk factor for failed amputation. Conclusion: These data suggest that elevated preoperative tissue L/P ratio is associated with worse outcomes in diabetic patients undergoing amputation, therefore pre-operative tissue L/P ratio can be used as a predictive target for limb amputation’s outcome in future clinical studies

Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago

Background: Literature suggests colonic resection and primary anastomosis (RPA) instead of Hartmann's procedure (HP) for the treatment of left-sided colonic emergencies. We aim to evaluate the surgical options globally used to treat patients with acute left-sided colonic emergencies and the factors that leading to the choice of treatment, comparing HP and RPA. Methods: This is a prospective, international, multicenter, observational study registered on ClinicalTrials.gov. A total 1215 patients with left-sided colonic emergencies who required surgery were included from 204 centers during the period of March 1, 2020, to May 31, 2020. with a 1-year follow-up. Results: 564 patients (43.1%) were females. The mean age was 65.9 ± 15.6 years. HP was performed in 697 (57.3%) patients and RPA in 384 (31.6%) cases. Complicated acute diverticulitis was the most common cause of left-sided colonic emergencies (40.2%), followed by colorectal malignancy (36.6%). Severe complications (Clavien-Dindo ≥ 3b) were higher in the HP group (P < 0.001). 30-day mortality was higher in HP patients (13.7%), especially in case of bowel perforation and diffused peritonitis. 1-year follow-up showed no differences on ostomy reversal rate between HP and RPA. (P = 0.127). A backward likelihood logistic regression model showed that RPA was preferred in younger patients, having low ASA score (≤ 3), in case of large bowel obstruction, absence of colonic ischemia, longer time from admission to surgery, operating early at the day working hours, by a surgeon who performed more than 50 colorectal resections. Conclusions: After 100 years since the first Hartmann's procedure, HP remains the most common treatment for left-sided colorectal emergencies. Treatment's choice depends on patient characteristics, the time of surgery and the experience of the surgeon. RPA should be considered as the gold standard for surgery, with HP being an exception

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

Background: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. Methods: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. Findings: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96–1·28). Interpretation: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. Funding: National Institute for Health Research Health Services and Delivery Research Programme

The emerging role of microdialysis in diabetic patients undergoing amputation for limb ischaemia

Introduction: Leg ischaemia in diabetic patients is a result of macro and microcirculation problems. We used microdialysis technique to monitor tissue microcirculation and extracellular biochemistry in order to predict the outcome of amputation.Background Data: Diabetic patients with ischaemic leg undergoing limb amputation carry high mortality and morbidity rates. Decision making for the level of amputation is critical. Current diagnostic techniques cannot be used as optimal prognostic factor for the level or the success of the amputation due to inadequate evaluation of leg microcirculation.Methods: 165 diabetic patients who underwent limb amputation for leg ischaemia were enrolled. A microdialysis catheter was placed preoperatively to the level of the intended flap for the stump reconstruction. Data were collected for 24 hours and were analysed for the levels of glucose, glycerol, lactate and pyruvate. Patients were then amputated and monitored regarding the clinical outcome of the amputations.Results: Patients were divided into two groups according to success of amputation. There was no difference between the two groups regarding gender, ASA, BMI, co-morbidities, diagnostic modality used, level of amputation, as well as in glucose, glycerol, and pyruvate levels. However, local concentrations of lactate were significantly different between the two groups and lactate/pyruvate (L/P) ratio was strongly associated as a risk factor for failed amputation.Conclusion: These data suggest that elevated preoperative tissue L/P ratio is associated with worse outcomes in diabetic patients undergoing amputation, therefore pre-operative tissue L/P ratio can be used as a predictive target for limb amputation’s outcome in future clinical studies.Εισαγωγή: Η ισχαιμία των κάτω άκρων που παρατηρείται σε διαβητικούς ασθενείς είναι αποτέλεσμα των διαταραχών που συμβαίνουν στην μακρο και μικροκυκλοφορία. Στην παρούσα μελέτη χρησιμοποιήσαμε την τεχνική της μικροδιάλυσης για να αξιολογήσουμε την επάρκεια της μικροκυκλοφορίας με σκοπό να μπορέσουμε να προκαθορίσουμε προεγχειρητικά το επίπεδο του ακρωτηριασμού του σκέλους.Δεδομένα: Οι διαβητικοι ασθενείς που υποβάλονται σε ακρωτηριασμό κάτω άκρου εξαιτίας διαβητικής αγγειοπάθειας, εμφανίζουν υψηλά ποσοστά νοσηρότητας και θνησιμότητας. Η απόφαση για το επίπεδο του ακρωτηριασμού είναι ιδιαίτερα κρίσιμη. Οι παρούσες τεχνικές αξιολόγησης δεν είναι ιδανικές για τον προκαθορισμό του ιδανικού επιπέδου ακρωτηριασμού αφού δεν αξιολογούν ικανοποιητικά τη μικροκυκλοφορία στο πάσχον άκρο. Μέθοδος: Στη παρούσα μελέτη συμμετείχαν 165 διαβητικοί ασθενείς οι οποίοι ακρωτηριάστηκαν εξαιτίας ισχαιμίας κάτω άκρου. Ο καθετήρας μικροδιάλυσης τοποθετήθηκε προεγχειρητικά στο επίπεδο του προγραμματισμένου κρημνού που θα χρησιμοποιούνται για τη δημιουργία του χειρουργικού κολοβώματος. Ακολούθως ακολουθούσε η συλλογή δεδομένων ιστικής βιοχημείας για 24 ώρες. Τα δεδομένα αυτά αφορούσαν τη συγκέντρωση γλυκόζης, γλυκερόλης, γαλακτικού και πυροσταφυλικού οξέος στο διάμεσο ιστό. Ακολούθως οι ασθενείς ακρωτηριάζονταν και αξιολογούνταν η κλινική έκβαση του ακρωτηριασμού. Αποτελέσματα: Οι ασθενείς της μελέτης χωρίστηκαν σε 2 ομάδες μετεγχειρητικά ανάλογα με την έκβαση του ακρωτηριασμού (επιτυχής ή αποτυχής). Δεν υπήρχε στατιστικά σημαντική διαφορά μεταξύ των 2 ομάδων σχετικά με το φύλο, ASA, BMI, την ύπαρξη διαφόρων νοσηροτήτων, τη διαγνωστική μέθοδο που χρησιμοποιήθηκε για τον καθορισμό του επιπέδου του ακρωτηριασμού και του επιπέδου του ακρωτηριασμού. Επίσης δεν υπήρχε διαφορά ούτε στις συγκεντώσεις γλυκόζης, γλυκερόλης και πυροσταφυλικού οξέος στο διάμεσο ιστό, μεταξύ των δύο ομάδων. Η τοπική συγκέντρωση γαλακτικού οξέος ήταν σημαντικά διαφορετική μεταξύ των δύο ομάδων και ο λόγος του γαλακτικού / πυροσταφυλικού οξέος σχετίστηκε ως ανεξάρτητος παράγοντας κυνδίνου για την κλινική έκβαση του ακρωτηριασμού.Συμπέρασμα: Τα αποτελέσματα της μελέτης μας υποδηλώνουν ότι η αυξημένη συγκέντρωση προεγχειρητικά του λόγου της συγκέντρωσης γαλακτικού / πυροσταφυλικού οξέος στο υπό μέλετη επίπεδο ακρωτηριασμού, σχετίζεται με αυξημένη πιθανότητα αποτυχίας και ως εκ τούτου η προεγχειρητική χρήση του λόγου αυτού μπορεί να χρησιμοποιηθεί με υψηλό ποσοστό ευαισθησίας και ειδικότητας ως προγνωστικός παράγοντας για την κλινική έκβαση των ακρωτηριασμών σε διαβητικούς ασθενείς

The emerging role of microdialysis in diabetic patients undergoing amputation for limb ischemia

Lower limb ischemia in diabetic patients is a result of macro- and microcirculation dysfunction. Diabetic patients undergoing limb amputation carry high mortality and morbidity rates, and decision making concerning the level of amputation is critical. Aim of this study is to evaluate a novel microdialysis technique to monitor tissue microcirculation preoperatively and predict the success of limb amputation in such patients. Overall, 165 patients with type 2 diabetes mellitus undergoing lower limb amputation were enrolled. A microdialysis catheter was placed preoperatively at the level of the intended flap for the stump reconstruction, and the levels of glucose, glycerol, lactate and pyruvate were measured for 24consecutive hours. Patients were then amputated and monitored for 30 days regarding the outcome of amputation. Failure of amputation was defined as delayed healing or stump ischemia. Patients were divided into two groups based on the success of amputation. There was no difference between the two groups regarding gender, ASA score, body mass index, comorbidities, diagnostic modality used, level of amputation, as well as glucose, glycerol, and pyruvate levels. However, local concentrations of lactate were significantly different between the two groups and lactate/pyruvate (L/P) ratio was independently associated with failed amputation (threshold defined at 25.35). Elevated preoperative tissue L/P ratio is independently associated with worse outcomes in diabetic patients undergoing limb amputation. Therefore, preoperative tissue L/P ratio could be used as a predicting tool for limb amputation's outcome, although more clinical data are needed to provide safer conclusions

Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago /

Background: Literature suggests colonic resection and primary anastomosis (RPA) instead of Hartmann’s procedure (HP) for the treatment of left-sided colonic emergencies. We aim to evaluate the surgical options globally used to treat patients with acute left-sided colonic emergencies and the factors that leading to the choice of treatment, comparing HP and RPA. Methods: This is a prospective, international, multicenter, observational study registered on ClinicalTrials.gov. A total 1215 patients with left-sided colonic emergencies who required surgery were included from 204 centers during the period of March 1, 2020, to May 31, 2020. with a 1-year follow-up. Results: 564 patients (43.1%) were females. The mean age was 65.9 ± 15.6 years. HP was performed in 697 (57.3%) patients and RPA in 384 (31.6%) cases. Complicated acute diverticulitis was the most common cause of left-sided colonic emergencies (40.2%), followed by colorectal malignancy (36.6%). Severe complications (Clavien-Dindo ≥ 3b) were higher in the HP group (P < 0.001). 30-day mortality was higher in HP patients (13.7%), especially in case of bowel perforation and diffused peritonitis. 1-year follow-up showed no differences on ostomy reversal rate between HP and RPA. (P = 0.127). A backward likelihood logistic regression model showed that RPA was preferred in younger patients, having low ASA score (≤ 3), in case of large bowel obstruction, absence of colonic ischemia, longer time from admission to surgery, operating early at the day working hours, by a surgeon who performed more than 50 colorectal resections. Conclusions: After 100 years since the first Hartmann’s procedure, HP remains the most common treatment for left-sided colorectal emergencies. Treatment’s choice depends on patient characteristics, the time of surgery and the experience of the surgeon. RPA should be considered as the gold standard for surgery, with HP being an exception