Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).

BACKGROUND: Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy. METHODS: An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes. RESULTS: A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194). CONCLUSION: Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).

ANTECEDENTES: Varios estudios no aleatorizados y retrospectivos sugieren que la anastomosis intracorpórea (intracorporeal anastomosis, IA) tiene ventajas sobre la anastomosis extracorpórea (extracorporeal anastomosis, EA) en la colectomía laparoscópica derecha, pero no hay suficientes evidencias científicas. El objetivo del estudio fue comparar los resultados a corto plazo y definir los posibles beneficios de la anastomosis intracorpórea versus extracorpórea en la colectomía derecha laparoscópica electiva. MÉTODOS: Se realizó un ensayo clínico prospectivo y aleatorizado de mayo de 2015 a junio de 2018. El criterio de valoración principal fue la duración de la estancia hospitalaria. Los criterios de valoración secundarios fueron los eventos técnicos intraoperatorios y los resultados clínicos postoperatorios. RESULTADOS: Se aleatorizaron 140 pacientes. El tiempo quirúrgico fue más largo para la IA que para la EA (149,49 ± 27,24 versus 123,35 ± 36,56 min; P = 0,001). La longitud de la herida fue más corta en la IA (6,65 ± 1,21 versus 8,72 ± 1,44 cm; P < 0,001). La función digestiva se recuperó antes en la IA que en la EA (2,3 versus 3,3 días, P = 0,003) y la incidencia de íleo paralítico fue menor (13% versus 30%, P = 0,022). Los requisitos de analgesia postoperatoria fueron menores con la IA (39 ± 24,3 versus 53 ± 26; P < 0,001) y la puntuación de dolor (EVA) también fue menor (P < 0,035). El descenso de la hemoglobina en el postoperatorio y la hemorragia gastrointestinal baja fueron menores en la IA que en la EA (-8,83 ± 1,7 versus -17,07 ± 1,7 mg/dl; P = 0,001) y (2,8% versus 14%; P = 0,031), respectivamente. La clasificación de Clavien-Dindo mostró que la IA se asoció con resultados significativamente mejores que la EA: grado I (10% versus 27% P = 0,016); grado II (18% versus 35%, P = 0,0369). La puntuación del índice de complicación integral (comprehensive complication index, CCI) fue menor en el grupo IA (5,33 ± 9,2 versus 11,15 ± 14,34; P = 0,006). La estancia hospitalaria fue más corta en el grupo de IA pero sin diferencia significativa (5,65 ± 3,75 versus 6,58 ± 4,63 días; P = 0,194). CONCLUSIÓN: La IA presenta ventajas clínicas sobre la EA en la colectomía derecha laparoscópica.

[Association between refractory hypertension and cardiometabolic risk. The HIPERFRE study]. / Asociación entre hipertensión refractaria y riesgo cardiometabólico. Estudio HIPERFRE.

BACKGROUND AND AIM: Resistant hypertension (R-HT) is defined by the presence of uncontrolled blood pressure in patients treated with three or more drugs, being one of them diuretic. We sough to evaluate the prevalence and features of patients with R-HT attended at Primary Care of our environment. METHOD: 1724 hypertensive patients attended by 35 physicians at 14 Primary Care Units were analyzed in this descriptive, transversal, multicentral study. RESULTS: Patients (41.5% males) with a mean age of 67+/-11 years, being half of them obese. Blood pressure is controlled in 41.6% and the prevalence of R-HT is of 13.2%. This later group of patients is characterized by an older age (69 vs 67 years, p<0.01) and more frequent obesity (62% vs 43%, p<0.001), diabetes (55% vs 11%, p<0.001), hyperlipidemia (68% vs 59%, p<0.05), and metabolic syndrome (68% vs 22%, p<0.001). At least half of them present some kind of end-organ damage. No pharmacologycal treatment is prescribed to 3% of these patients and 37% of them are on monotherapy. There is a higher prescription of angiotensin receptor, calcium channel, beta and alfa-blockers in the group of patients with R-HT. There is an independent and direct relationship between R-HT and age, male gender, diabetes, obesity, metabolic syndrome, and an inverse relationship with ischemic cardiopathy. CONCLUSIONS: The prevalence of R-HT at Primary Care Units is of 13% and is related with age, male gender and metabolic risk factors.