Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework.

BACKGROUND: Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robotic-assisted surgery expansion. OBJECTIVE: To demonstrate the safety and efficacy of a novel miniaturized robotic-assisted surgery device in colectomy. DESIGN: Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up framework (stage 2b, exploration). SETTINGS: Three centers with high-volume robotic colorectal cases and surgeons. PATIENTS: Patients scheduled for a right or left colectomy for benign or malignant disease. INTERVENTION: Colectomy with the novel miniaturized robotic-assisted surgery device. MAIN OUTCOME MEASURES: For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. RESULTS: Thirty patients (13 women, 17 men) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent of patients (n = 21) were overweight/obese and 53.3% of patients (n = 16) had prior abdominal surgery. Forty percent of patients had malignant and 60% had benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was a median of 146 (range, 80-309) minutes; console time was 70 (range, 34-174) minutes. There were no conversions to open surgery and no intraoperative or device-related adverse events. In 100% of patients (n = 30), the primary dissection was completed, and hemostasis was maintained with the novel miniaturized robotic-assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities. LIMITATIONS: Single-arm study, short-term follow-up. CONCLUSIONS: This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated that it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video Abstract . SEGURIDAD Y EFICACIA DE UN NOVEDOSO SISTEMA DE CIRUGA ASISTIDA POR ROBOT MINIATURIZADO EN COLECTOMA UN ESTUDIO CLNICO PROSPECTIVO DE INVESTIGACIN DE EXENCIN DE DISPOSITIVO QUE UTILIZA EL MARCO IDEAL: ANTECEDENTES:La robótica ha aumentado las tasas de cirugía mínimamente invasiva, con claras ventajas sobre la cirugía abierta. Sin embargo, las plataformas robóticas actualmente disponibles comercialmente tienen problemas con los dispositivos y sistemas que limitan la expansión de la cirugía asistida por robot.OBJETIVO:Demostrar la seguridad y eficacia de un novedoso dispositivo de cirugía asistida por robot miniaturizado en colectomía.DISEÑO:Estudio clínico prospectivo de investigación de exención de dispositivo siguiendo el marco IDEAL (Etapa 2b, exploración).ESCENARIO:Tres centros con cirujanos y casos colorrectales robóticos de gran volumen.PACIENTES:Pacientes programados para colectomía derecha o izquierda por enfermedad benigna o maligna.INTERVENCIÓN:Colectomía con el nuevo dispositivo de cirugía asistida por robot miniaturizado.PRINCIPALES MEDIDAS DE RESULTADO:Para la seguridad, eventos adversos intraoperatorios y relacionados con el dispositivo y morbilidad a 30 días. Para la evaluación de la eficacia, la finalización exitosa de los pasos predefinidos sin conversión.RESULTADOS:Se analizaron treinta pacientes (13 mujeres, 17 hombres). La edad media fue 59,4 (DE 13,4) años. El 70% (n=21) tenía sobrepeso/obesidad y el 53,3% (n=16) había tenido cirugía abdominal previa. El 40% tenía enfermedad maligna y el 60% benigna. Los casos fueron 15 colectomías derechas y 15 izquierdas. La mediana del tiempo operatorio general fue de 146 (rango, 80-309) minutos; 70 (rango, 34-174) minutos fue el tiempo de consola. No hubo conversiones a cirugía abierta ni eventos adversos intraoperatorios o relacionados con el dispositivo. En el 100% (n=30), se completó la disección primaria y se mantuvo la hemostasia con el novedoso dispositivo de cirugía asistida por robot miniaturizado. La tasa de morbilidad menor fue de un 26,7% y mayor un 3,3%. La mediana de estadía fue de 2 días. No hubo mortalidad.LIMITACIONES:Estudio de un solo brazo, corto plazo de seguimiento.CONCLUSIONES:Este primer estudio clínico de un novedoso dispositivo de cirugía asistida por robot miniaturizado según el marco IDEAL demostró que era seguro y eficaz. Dado este éxito, se planean evaluaciones adicionales y seguimiento a largo plazo del dispositivo de cirugía asistida por robot miniaturizado para comparar la efectividad clínica y económica en la cirugía colorrectal. (Traducción-Dr. Felipe Bellolio ).

Robotic Intracorporeal Anastomosis.

Robotic intracorporeal anastomosis is currently increasingly used for the performance of colorectal anastomosis. We describe the technical details for the proper performance of an iso- and anti-peristaltic anastomosis including the set up of the robotic platform and the performance of the anastomosis.

The influence of body mass index on clinical short-term outcomes in robotic colorectal surgery.

BACKGROUND: Robotic surgery has been developed to address the technical limitations of laparoscopic surgery and might result in similar outcomes for patients with low and high body mass index (BMI). METHODS: Demographic, peri-operative data and surrogate oncologic markers for colorectal cancer of patients that underwent robotic colorectal procedures were collected in a prospective database and analyzed. RESULTS: 103 consecutive patients (36 normal-weight, 33 overweight, 34 obese) underwent robotic colorectal surgery from 11/2011 to 05/2012. While operating room (OR) time was longer for the obese patients (123.4 vs 137.9 and 154.7 min), results for estimated blood loss (104.2 vs 153 and 155.9 mL), conversions (2.8 vs 6.1 and 5.9%), complications (19.4 vs 21.2 and 32.4%), re-admissions (11.1 vs 112.1 and 20.6) and mortality (0% for all) were comparable. BMI did not affect the surrogate markers in patients with malignancies. CONCLUSIONS: Data demonstrates that patient BMI does not have a significant impact on short-term clinical outcomes during robotic colorectal surgery. Copyright © 2015 John Wiley & Sons, Ltd.

Robotic Rectal Cancer Resection: A Retrospective Multicenter Analysis.

BACKGROUND: Conventional laparoscopy has been applied to colorectal resections for more than 2 decades. However, laparoscopic rectal resection is technically demanding, especially when performing a tumor-specific mesorectal excision in a difficult pelvis. Robotic surgery is uniquely designed to overcome most of these technical limitations. The aim of this study was to confirm the feasibility of robotic rectal cancer surgery in a large multicenter study. METHODS: Retrospective data of 425 patients who underwent robotic tumor-specific mesorectal excision for rectal lesions at seven institutions were collected. Outcome data were analyzed for the overall cohort and were stratified according to obese versus non-obese and low versus ultra-low resection patients. RESULTS: Mean age was 60.9 years, and 57.9 % of patients were male. Overall, 51.3 % of patients underwent neoadjuvant therapy, while operative time was 240 min, mean blood loss 119 ml, and intraoperative complication rate 4.5 %. Mean number of lymph nodes was 17.4, with a positive circumferential margin rate of 0.9 %. Conversion rate to open was 5.9 %, anastomotic leak rate was 8.7 %, with a mean length of stay of 5.7 days. Operative times were significantly longer and re-admission rate higher for the obese population, with all other parameters comparable. Ultra-low resections also had longer operative times. CONCLUSION: Robotic-assisted minimally invasive surgery for the treatment of rectal cancer is safe and can be performed according to current oncologic principles. BMI seems to play a minor role in influencing outcomes. Thus, robotics might be an excellent treatment option for the challenging patient undergoing resection for rectal cancer.

The influence of fluorescence imaging on the location of bowel transection during robotic left-sided colorectal surgery.

BACKGROUND: Hypoperfusion is an important risk factor for anastomotic leakage in colorectal surgery. This study was designed to evaluate the impact of fluorescence imaging on visualization of perfusion and subsequent change of transection line during left-sided robotic colorectal resections. METHODS: Patients scheduled for robotic left-sided colon or rectal resections were enrolled in this prospective, multicenter study. Resections were performed as per each surgeon's preference. After complete colorectal mobilization, ligation of blood vessels, and distal transection of the bowel, the mesocolon was completely divided to the planned proximal or distal transection line, which was marked in white light. Indocyanine green was injected intravenously and the transection location(s) and/or distal rectal stump, if applicable, were re-assessed in fluorescent imaging mode. Imaging information, perioperative, and early postoperative outcomes were recorded. An independent video review of the surgeries was performed. RESULTS: Data for 40 patients (20 female/20 male) with a mean age of 63.9 years and a mean body mass index of 27.6 kg/m(2) were analyzed. Fluorescence imaging resulted in a change of the proximal transection location in 40 % (16/40) of patients. There was one change in the distal transection location in a patient with benign disease. The use of fluorescence imaging took an average of 5.1 min of the mean overall operative room time of 232 min. Two patients (5 %) with a change in transection line developed an anastomotic leak at postoperative days 15 and 40. CONCLUSION: Fluorescence imaging provides additional information during determination of transection location in left-sided colorectal procedures. This results in a significant change of transection location, particularly at the proximal transection site. Further research needs to be conducted with larger patient cohorts and in comparative design to determine actual effect on anastomotic leak rate.

Neoadjuvant bevacizumab, oxaliplatin, 5-fluorouracil, and radiation for rectal cancer.

PURPOSE: To evaluate the feasibility and pathologic complete response rate of induction bevacizumab + modified infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) 6 regimen followed by concurrent bevacizumab, oxaliplatin, continuous infusion 5-fluorouracil (5-FU), and radiation for patients with rectal cancer. METHODS AND MATERIALS: Eligible patients received 1 month of induction bevacizumab and mFOLFOX6. Patients then received 50.4 Gy of radiation and concurrent bevacizumab (5 mg/kg on Days 1, 15, and 29), oxaliplatin (50 mg/m(2)/week for 6 weeks), and continuous infusion 5-FU (200 mg/m(2)/day). Because of gastrointestinal toxicity, the oxaliplatin dose was reduced to 40 mg/m(2)/week. Resection was performed 4-8 weeks after the completion of chemoradiation. RESULTS: The trial was terminated early because of toxicity after 26 eligible patients were treated. Only 1 patient had significant toxicity (arrhythmia) during induction treatment and was removed from the study. During chemoradiation, Grade 3/4 toxicity was experienced by 19 of 25 patients (76%). The most common Grade 3/4 toxicities were diarrhea, neutropenia, and pain. Five of 25 patients (20%) had a complete pathologic response. Nine of 25 patients (36%) developed postoperative complications including infection (n = 4), delayed healing (n = 3), leak/abscess (n = 2), sterile fluid collection (n = 2), ischemic colonic reservoir (n = 1), and fistula (n = 1). CONCLUSIONS: Concurrent oxaliplatin, bevacizumab, continuous infusion 5-FU, and radiation causes significant gastrointestinal toxicity. The pathologic complete response rate of this regimen was similar to other fluorouracil chemoradiation regimens. The high incidence of postoperative wound complications is concerning and consistent with other reports utilizing bevacizumab with chemoradiation before major surgical resections.

Does alvimopan enhance return of bowel function in laparoscopic right colectomy?

Alvimopan, a peripherally acting Mu-opioid receptor antagonist, has been shown to enhance recovery of gastrointestinal (GI) function in open bowel resection. The aim of this study was to determine the effect of Alvimopan on patients undergoing laparoscopic right colectomies in preventing postoperative ileus (POI). A prospective, nonrandomized trial of laparoscopic right colectomies was carried out with and without perioperative Alvimopan. The length of stay (LOS), time to first flatus, bowel movement, and tolerance of solid foods were recorded. Additionally, any occurrences of POI defined as the need for insertion of a nasogastric tube (NGT) were also noted. Student t tests were used for statistical analysis. A total of 33 patients underwent laparoscopic right colectomies for both benign and malignant diseases from October 2008, to December 2009. Sixteen patients received Alvimopan, whereas 17 patients did not. The demographics of both patient groups were similar. Patients receiving Alvimopan had an accelerated return of bowel function in terms of first flatus (2.37 vs 3.34; P = 0.03), tolerance of solid food (2.75 vs 3.94; P = 0.03), and first stool (2.53 vs 3.80; P = 0.04). There was a trend toward shorter LOS in patients receiving Alvimopan (P = 0.07). Two patients with POI requiring NGT did not receive Alvimopan. Alvimopan was successful in enhancing return of GI function in laparoscopic right colectomies and avoiding POI. The decreased LOS trended but did not approach statistical significance. A large randomized prospective trial will be needed to determine the validity of this study.

Safety and learning curve in robotic colorectal surgery.

Robotic surgery has recently started to be used for minimally invasive colorectal surgery. Because of limited access and high cost, very few colorectal units are available in the US. We describe our experience with benign and malignant disease since September 2008 in a dedicated colorectal practice. A prospective collected robotic database was queried for colon and rectal procedures. Anonymized demographic, intraoperative, and postoperative data, and pathology information, were collected and analyzed. A total of 48 robotic procedures for colorectal maladies were performed in the study period. There were 35 females and 13 males. The average age was 57 years. Twenty-two cases were performed for diverticulitis, 13 for malignancy (10 distal rectum (<8 cm anal verge), two rectosigmoid, and one ascending colon cancer), 10 for rectal prolapse, two for rectovaginal fistula, and one for incidental appendiceal mucocele found during a gynecologic resection. The average operating room time (OR) was 162 min and there were no conversions to open procedures. Blood loss averaged 104 mL. Mean length of hospital stay (LOS) was 5.4 days. Patient readmission occurred in 27.3% of cases. The anastamotic leak rate was 2.1% (one patient). No mortalities were reported. When the analysis was performed for colorectal malignancies (13 procedures), there were nine females and four males. Average age was 59 years. The mean OR time was 191.1 min. Mean intraoperative blood loss was 123 mL and there were no conversions to open surgery. Average LOS was 7.0 days. There was one anastamotic leak (7.7%). The length of stay was increased for the patient with anastamotic leak (18 days) and for a patient with high stoma output and postoperative ileus (17 days). Readmission rate was 30.1%. The total number of lymph nodes retrieved averaged 19.5, with a mean distal margin of 3.0 cm and in all cases negative radial margins. Robotic colorectal surgery for benign and malignant disease is safe, and short-term outcomes are comparable with those of traditional and laparoscopic surgery. Oncologic resections were adequate with excellent lymph node sampling and radial and distal margins.

Retained capsule endoscope leading to the identification of small bowel adenocarcinoma in a patient with undiagnosed Crohn disease.

Small intestinal neoplasia is a rare condition that frequently presents a diagnostic challenge. We describe the case of a 70-year-old patient who presented with several years of chronic, intermittent abdominal pain, previously diagnosed as irritable bowel syndrome. Radiographic evaluation, including upper gastrointestinal series with small bowel follow-through and computed tomography, demonstrated dilated small bowel with possible strictures. Colonoscopy and upper endoscopy were unrevealing. Attempted capsule endoscopy resulted in capsule retention. Subsequent laparoscopy led to the identification of severe, active Crohn disease with strictures, ulcers, crypt abscesses, pyloric metaplasia, and transmural inflammation. Extensive flat and polypoid high- and low-grade dysplasia were present, as well as an area of well-differentiated adenocarcinoma invading into the muscularis propria. We discuss the epidemiology, pathogenesis, and diagnosis of small bowel malignancy.

When the bough breaks: a 10-year review of logging injuries treated at a rural trauma center in Pennsylvania.

The purpose of this study was to describe logging-related injuries at a Pennsylvania trauma center and evaluate the impact of helmets and profession. Charts of patients from 1990 through 1999 admitted after logging accidents were retrospectively reviewed. Most injuries were to the head (71 in 28 patients). Injury Severity Score was greater for helmeted loggers (21.0 vs 11.8; P = 0.02) but did not differ by profession. Mean hospital stay was not significantly different for helmeted loggers (9.6 vs 5.4 days, P = 0.499). Mean length of stay was 8.2 days and 3.5 days for professionals and nonprofessionals, respectively (P = 0.01). Professional loggers tended to remain hospitalized longer. Helmet use does not appear to affect injury severity; however, this could be a result of the catastrophic nature of many logging accidents. Most loggers in this study were not wearing helmets, which suggests that improved educational efforts are needed to improve safety in this dangerous occupation.

Clinical rib fractures: are follow-up chest X-rays a waste of resources?

Rib fractures (RFs) are estimated to be present in 10 per cent of all traumatic injuries. However, up to 50 per cent of all fractures go undetected on the screening chest X-ray (CXR). The purpose of this study was to identify the incidence of clinical (CRFs) and objective rib fractures (ORFs) as well as to examine the utility of the routine follow-up CXR with regard to patient recovery and healthcare cost. We identified patients sustaining RF in addition to other traumatic injuries with an Injury Severity Score (ISS) < or = 15 and RF as the primary pathology. Five hundred fifty-two patients sustained blunt thoracic trauma with resultant RF. Two hundred nine patients had RFs and an ISS < or = 15. The average ISS was 8. Follow-up films illustrated that 93 per cent of CRFs had resolution of any pathology, 4 per cent had persistent X-ray findings, and 4 per cent were lost to follow-up. Ultimately 93 per cent of patients with CRF were able to resume daily activities without disability and 3 per cent incurred lifestyle changes at home or work, which was significantly better than those with ORFs (P < 0.05). Follow-up films produced no change in clinical management and cost approximately $2000/year. The prognosis for CRFs is excellent if treatment consists of appropriate pain management and pulmonary rehabilitation. We do not advocate routine follow-up CXRs in addition to physical examination for the evaluation of CRFs unless clinical deterioration is evident.

Anal stenosis and mucosal ectropion.

Anal stenosis (AS) or stricture is defined as the loss of compliant natural elasticity of the anal opening, which then becomes abnormally tight and fibrous. It is a very disabling condition, worsened by the patient's embarrassment, but uncommon. The vast majority of cases are secondary to trauma, iatrogeny, inflammatory diseases, or neoplasia, or occur postradiation. Depending on the severity and level of involvement, AS can be classified as mild, moderate, or severe. Due to the rarity of this pathology and the different referral patterns among institutions, the etiology ranges widely between published reports. There are multiple surgical techniques that have been described for the correction or improvement of AS. Moderate or severe AS is the usual indication for operative treatment.