Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device.

INTRODUCTION: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. METHODS: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. RESULTS: 16 patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic Mucosal Resection (EMR) (6.3%), Endoscopic Submucosal Dissection ESD (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. In no case did rectal perforation or major complications requiring urgent reintervention occur. As for the level of reproducibility, safety, level of satisfaction with the device and evaluation of the blister, the evaluation on a scale of 0-10 (9.43, 9.71, 9.29 and 9.50 respectively). All the investigators have previous experience with transanal devices. CONCLUSIONS: The study demonstrates the efficacy and safety of UNI-VEC® for the treatment of rectal lesions. It will facilitate the implementation of hybrid procedures that seek to solve the limitations of pure endoscopic techniques by allowing the concomitant use of conventional laparoscopic and robotic instrumentation with the flexible endoscope.

The decline of axillary lymph node dissection in breast cancer. Evolution of its indication over the last 20 years. / El declive de la linfadenectomía axilar en el cáncer de mama. Evolución de su indicación durante los últimos 20 años.

INTRODUCTION: In last 20 years, lymph node staging procedures in breast cancer have been modified. The objective of this study is to describe the evolution of these procedures at our hospital. METHODS: A prospective observational study that included women with breast cancer who were treated surgically between 2001 and 2017. Four groups were identified according to the therapeutic regimen and 3 study periods defined by the lymph node dissection. RESULTS: 1319 patients met the inclusion criteria. Primary conservative surgery was the most frequent therapy (54.13%), and 615 (46.62%) axillary lymph node dissections (ALND) were performed in the 20-year study period. The percentage of ALND decreased progressively over time, going from 91% in the first period to 34% in the last period. The futile ALND fell to 6.6% in the last year. In the primary conservative surgery, no futile ALND was performed in the last two years. CONCLUSION: The introduction of sentinel lymph node biopsy and the ACOSOG Z0011 criteria have modified the indication for ALND. Thus, ALND without involvement have been reduced, thereby avoiding the associated morbidity. The study demonstrates the progressive decrease in the indication of lymphadenectomy in the different study groups, similar to reports by other authors. Several clinical trials have described that these changes have not negatively impacted survival.

Negative Pressure Wound Therapy for a Complicated Abdominal Laparotomy in Neonatal Necrotizing Enterocolitis: A Case Report.

Necrotizing enterocolitis (NEC) is the most common surgical emergency in neonatal intensive care units, and patients who require surgery have high mortality and morbidity rates. The utility of negative pressure in the management of adults with complicated abdominal wounds has been documented, but there are few reports describing the use of negative pressure wound therapy (NPWT) in children or following neonatal surgery. The case of a 6 day old, 5-weeks premature neonate with NEC is presented. An exploratory midline laparotomy was performed on day 3 of life owing to rectal bleeding and abdominal distension that did not respond to gastric decompression, bowel rest, and intravenous antibiotics. Ten (10) cm of necrosis in the distal ileum were noted and resected; in addition, an ileostomy was performed, and a Penrose drain was left in the surgical site. On postoperative day 5, the laparotomy dehisced. Continuous NPWT (50 mm Hg) was initiated and changed owing to patient tolerance to intermittent therapy (5 minutes on, 30 seconds off) at 80 mm Hg. By postoperative day 11, granulation tissue formation was complete. No surgical procedures were required for the complete closure of the abdominal wall, and no adverse reactions were noted. The baby was discharged from the hospital on postop day 15. In this patient, the use of negative pressure was found to be safe and facilitated management of a complicated abdominal wound in the presence of a stoma and the formation of healthy granulation tissue. Additional research is needed to help clinicians provide optimal, evidence-based care for dehisced wounds in this vulnerable population.