Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial.

BACKGROUND: The optimum timing for temporary ileostomy closure after low anterior resection is still open. OBJECTIVE: This trial aimed to compare early (2 wk) versus late (12 wk) stoma closure. DESIGN: The study included 2 parallel groups in a multicenter, randomized controlled clinical trial. SETTINGS: The study was conducted at 3 Swiss hospitals. PATIENTS: Patients undergoing low anterior resection and temporary ileostomy for cancer were included. INTERVENTIONS: Patients were randomly allocated to early or late stoma closure. Before closure, colonic anastomosis was examined for integrity. MAIN OUTCOME MEASURES: The primary efficacy outcome was the Gastrointestinal Quality of Life Index 6 weeks after resection. Secondary end points included safety (morbidity), feasibility, and quality of life 4 months after low anterior resection. RESULTS: The trial was stopped for safety concerns after 71 patients were randomly assigned to early closure (37 patients) or late closure (34 patients). There were comparable baseline data between the groups. No difference in quality of life occurred 6 weeks (mean Gastrointestinal Quality of Life Index: 99.8 vs 106.0; p = 0.139) and 4 months (108.6 vs 107.1; p = 0.904) after index surgery. Intraoperative tendency of oozing (visual analog scale: 35.8 vs 19.3; p = 0.011), adhesions (visual analog scale: 61.3 vs 46.2; p = 0.034), leak of colonic anastomosis (19% vs 0%; p = 0.012), leak of colonic or ileal anastomosis (24% vs 0%; p = 0.002), and reintervention (16% vs 0%; p = 0.026) were significantly higher after early closure. The concept of early closure failed in 10 patients (27% vs 0% in the late closure group (95% CI for the difference, 9.4%-44.4%)). LIMITATIONS: The trial was prematurely stopped because of safety issues. The aimed group size was not reached. CONCLUSIONS: Early stoma closure does not provide better quality of life up to 4 months after low anterior resection but is afflicted with significantly adverse feasibility and higher morbidity when compared with late closure. See Video Abstract at http://links.lww.com/DCR/B665. CIERRE DE LA ILEOSTOMA TEMPORAL VERSUS SEMANAS POSTERIOR A LA RESECCIN RECTAL POR CNCER UNA ADVERTENCIA DE UN ESTUDIO MULTICNTRICO CONTROLADO RANDOMIZADO PROSPECTIVO: ANTECEDENTES:El momento óptimo para el cierre temporal de la ileostomía posterior a la resección anterior baja es aun controversial.OBJETIVO:Este estudio tuvo como objetivo comparar el cierre del estoma temprano (2 semanas) versus tardío (12 semanas).DISEÑO:Estudio clínico controlado, randomizado, multicéntrico, de dos grupos paralelos.ENTORNO CLINICO:El estudio se llevó a cabo en 3 hospitales suizos.PACIENTES:Se incluyeron pacientes sometidos a resección anterior baja e ileostomía temporal por cáncer.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente al cierre del estoma temprano o tardío. Antes del cierre, se examinó la integridad de la anastomosis colónica.PRINCIPALES MEDIDAS DE VALORACION:El principal resultado de eficacia fue el Índice de Calidad de Vida Gastrointestinal 6 semanas después de la resección. Los criterios secundarios incluyeron la seguridad (morbilidad), factibilidad y calidad de vida 4 meses posterior a la resección anterior baja.RESULTADOS:El estudio se detuvo por motivos de seguridad después de que 71 pacientes fueron asignados aleatoriamente a cierre temprano (37 pacientes) o cierre tardío (34 pacientes). Hubo datos de referencia comparables entre los grupos. No se produjeron diferencias en la calidad de vida 6 semanas (índice de calidad de vida gastrointestinal, media 99,8 vs. 106; p = 0,139) y 4 meses (108,6 vs 107,1, p = 0,904) después de la cirugía inicial. Tendencia intraoperatoria de supuración (escala analógica visual 35,8 vs 19,3, p = 0,011), adherencias (escala analógica visual 61,3 vs 46,2, p = 0,034), fuga de anastomosis colónica (19% vs 0%, p = 0,012), fuga de anastomosis colónica o ileal (24% vs 0%, p = 0,002) y reintervención (16% vs 0%, p = 0,026) fueron significativamente mayores después del cierre temprano. El concepto de cierre temprano fracasó en 10 pacientes (27% vs ninguno en el grupo de cierre tardío (intervalo de confianza del 95% para la diferencia: 9,4% a 44,4%)).LIMITACIONES:El estudio se detuvo prematuramente debido a problemas de seguridad. No se alcanzó el tamaño del grupo previsto.CONCLUSIÓN:El cierre temprano del estoma no proporciona una mejor calidad de vida hasta 4 meses posterior a una resección anterior baja, esto se ve afectado por efectos adversos significativos durante su realización y una mayor morbilidad en comparación con el cierre tardío. Consulte Video Resumen en http://links.lww.com/DCR/B665.

Procedural Surgical RCTs in Daily Practice: Do Surgeons Adopt Or Is It Just a Waste of Time?

OBJECTIVE: To assess the adoption of recommendation from randomized clinical trials (RCTs) and investigate factors favoring or preventing adoption. BACKGROUND: RCT are considered to be the cornerstone of evidence-based medicine by representing the highest level of evidence. As such, we expect RCT's recommendations to be followed rigorously in daily surgical practice. METHODS: We performed a structured search for RCTs published in the medical and surgical literature from 2009 to 2013, allowing a minimum of 5-year follow-up to convincingly test implementation. We focused on comparative technical or procedural RCTs trials addressing the domains of general, colorectal, hepatobiliary, upper gastrointestinal and vascular surgery. In a second step we composed a survey of 29 questions among ESA members as well as collaborators from their institutions to investigate the adoption of surgical RCTs recommendation. RESULTS: The survey based on 36 RCTs (median 5-yr citation index 85 (24-474), from 21 different countries, published in 15 high-ranked journals with a median impact factor of 3.3 (1.23-7.9) at the time of publication. Overall, less than half of the respondents (47%) appeared to adhere to the recommendations of a specific RCT within their field of expertise, even when included in formal guidelines. Adoption of a new surgical practice was favored by watching videos (46%) as well as assisting live operations (18%), while skepticism regarding the methodology of a surgical RCT (40%) appears to be the major reason to resist adoption. CONCLUSION: In conclusion, surgical RCTs appear to have moderate impact on daily surgical practice. While RCTs are still accepted to provide the highest level of evidence, alternative methods of evaluating surgical innovations should also be explored.

Correction to: Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial.

In the original version of the article, Philippe M. Glauser's, Philippe Brosi's, Benjamin Speich's, Samuel A. Käser's, Andres Heigl's, and Christoph A. Maurer's first and last names were interchanged. The names are correct as reflected here. The original article has been corrected.

Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial.

OBJECTIVES: Incisional hernia, a serious complication after laparotomy, is associated with high morbidity and costs. This trial examines the value of prophylactic intraperitoneal onlay mesh to reduce the risk of incisional hernia after a median follow-up time of 5.3 years. METHODS: We conducted a parallel group, open-label, single center, randomized controlled trial (NCT01003067). After midline incision, the participants were either allocated to abdominal wall closure according to Everett with a PDS-loop running suture reinforced by an intraperitoneal composite mesh strip (Group A) or the same procedure without the additional mesh strip (Group B). RESULTS: A total of 276 patients were randomized (Group A = 131; Group B = 136). Follow-up data after a median of 5.3 years after surgery were available from 183 patients (Group A = 95; Group B = 88). Incisional hernia was diagnosed in 25/95 (26%) patients in Group A and in 46/88 (52%) patients in Group B (risk ratio 0.52; 95% CI 0.36-0.77; p < 0.001). Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years. Between the second- and fifth-year follow-up period, no complication associated with the mesh could be detected. CONCLUSION: The use of a composite mesh in intraperitoneal onlay position significantly reduces the risk of incisional hernia during a 5-year follow-up period. TRIAL REGISTRATION NUMBER: Ref. NCT01003067 (clinicaltrials.gov).

Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial.

BACKGROUND: Incisional hernias still are a major concern after laparotomy and are causing substantial morbidity. This study examines the feasibility, safety and incisional hernia rate of the use of a prophylactic intraperitoneal onlay mesh stripe (IPOM) to prevent incisional hernia following midline laparotomy. METHODS: This prospective, randomized controlled trial randomly allocated patients undergoing median laparotomy either to mass closure of the abdominal wall with a PDS-loop running suture reinforced by an intraperitoneal composite mesh stripe (Group A) or to the same procedure without the additional mesh stripe (Group B). Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. Secondary endpoints are were the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years. RESULTS: A total of 267 patients were included in this study. Follow-up data 2 years after surgery was available from 210 patients (Group A = 107; Group B = 103). An incisional hernia was diagnosed in 18/107 (17%) patients in Group A and in 40/103 (39%) patients in Group B (p < 0.001). A surgical operation due to an incisional hernia was conducted for 12/107 (11%) patients in Group A and for 24/103 (23%) patients in Group B (p = 0.039). In both groups, minor and major complications as well as postoperative pain are reported with no statistically significant difference between the groups, even in contaminated situations. CONCLUSIONS: This first randomized clinical trial indicates that the placement of a non-absorbable IPOM-stripe with prophylactic intention may significantly reduce the risk for a midline incisional hernia. TRIAL REGISTRATION: Ref. NCT01003067 (clinicaltrials.gov).

Implantation of a stent graft in the right pulmonary artery enables radical resection of a central endothelial sarcoma of the left pulmonary artery.

In a patient with a huge endothelial sarcoma of the left pulmonary artery, we report successful implantation of a stent graft in the right pulmonary artery, including the pulmonary arterial trunk. This preoperative measure enabled a safe and radical left-sided pneumonectomy, including the tumor and the central parts of the left pulmonary artery. No major blood loss occurred, and neither use of a heart-lung machine nor cardiopulmonary bypass was necessary.

Tissue banking in a regional hospital: a promising future concept? First report on fresh frozen tissue banking in a hospital without an integrated institute of pathology.

BACKGROUND: Vital tissue provided by fresh frozen tissue banking is often required for genetic tumor profiling and tailored therapies. However, the potential patient benefits of fresh frozen tissue banking are currently limited to university hospitals. The objective of the present pilot study--the first one in the literature--was to evaluate whether fresh frozen tissue banking is feasible in a regional hospital without an integrated institute of pathology. METHODS: Patients with resectable breast and colon cancer were included in this prospective study. Both malignant and healthy tissue were sampled using isopentan-based snap-freezing 1 h after tumor resection and stored at -80 °C before transfer to the main tissue bank of a University institute of pathology. RESULTS: The initial costs to set up tissue banking were 35,662 US$. Furthermore, the running costs are 1,250 US$ yearly. During the first 13 months, 43 samples (nine samples of breast cancer and 34 samples of colon cancer) were collected from 41 patients. Based on the pathology reports, there was no interference with standard histopathologic analyses due to the sample collection. CONCLUSIONS: This is the first report in the literature providing evidence that tissue banking in a regional hospital without an integrated institute of pathology is feasible. The interesting findings of the present pilot study must be confirmed by larger investigations.

Copper filtration in pediatric digital X-ray imaging: its impact on image quality and dose.

The effect of copper (Cu) filtration on image quality and dose in different digital X-ray systems was investigated. Two computed radiography systems and one digital radiography detector were used. Three different polymethylmethacrylate blocks simulated the pediatric body. The effect of Cu filters of 0.1, 0.2, and 0.3 mm thickness on the entrance surface dose (ESD) and the corresponding effective doses (EDs) were measured at tube voltages of 60, 66, and 73 kV. Image quality was evaluated in a contrast-detail phantom with an automated analyzer software. Cu filters of 0.1, 0.2, and 0.3 mm thickness decreased the ESD by 25-32%, 32-39%, and 40-44%, respectively, the ranges depending on the respective tube voltages. There was no consistent decline in image quality due to increasing Cu filtration. The estimated ED of anterior-posterior (AP) chest projections was reduced by up to 23%. No relevant reduction in the ED was noted in AP radiographs of the abdomen and pelvis or in posterior-anterior radiographs of the chest. Cu filtration reduces the ESD, but generally does not reduce the effective dose. Cu filters can help protect radiosensitive superficial organs, such as the mammary glands in AP chest projections.

Revascularization for chronic critical lower limb ischemia in octogenarians is worthwhile.

OBJECTIVE: Advanced age is considered a relative contraindication for surgical revascularization in patients with peripheral arterial occlusive disease. Our aim was to analyze the usefulness of endovascular and surgical revascularization in patients older than 80 years with chronic critical leg ischemia (CLI). Our hypothesis was that the clinical benefit of lower extremity revascularization is limited in octogenarians. METHODS: This was a prospective cohort study with a 1-year follow-up. Subjects included a consecutive series (January 1999 to June 2004) of patients presenting with CLI. Revascularization cohorts were either open surgical or endovascular with conservatively treated patients as a reference group. Prospective follow-up occurred after 30 days and 2, 6, and 12 months. The primary end point was sustained clinical success, defined as a categorical upward shift in clinical symptoms according to Rutherford, without major amputation and without the need for repeated target extremity revascularization (TER). Secondary clinical success was defined accordingly, including repeated TER. Mortality, major amputation, and TER were separately calculated end points. All results were stratified for age categories of nonoctogenarians (<80 years) and octogenarians (> or =80 years). Cumulative outcome was determined by the Kaplan-Meier method, and differences were assessed by log-rank tests. Multivariable analysis was performed by using Cox proportional regression. RESULTS: A total of 376 patients (158 women; mean age, 75.8 +/- 10.7 years) with 416 critically ischemic limbs were analyzed. Overall, 150 patients (39.9%) were older than 80 years, and 85 limbs were treated surgically (26 octogenarians; 30.6%), 207 limbs (96 octogenarians; 46.4%) were treated by endovascular means, and 124 limbs (45 octogenarians; 36.3%) were treated conservatively, including delayed revascularization procedures. Both sustained and secondary clinical success rates, as well as limb salvage rates, were higher in the revascularization cohorts as compared with conservatively treated patients, regardless of age category (P < .001, P < .001, and P = .006, respectively, by Cox proportional hazard model). Mortality was significantly higher in octogenarians (P = .006 by Cox proportional hazard model), particularly within 30 days after surgical revascularization (hazard ratio, 5.35; 95% confidence interval, 1.15-24.9). Patient age category did not affect the rate of major amputations or TER. CONCLUSIONS: Individually tailored revascularization improves the outcome of CLI in octogenarians as well as in nonoctogenarians; even so, endovascular revascularization should be preferred in octogenarians because of the higher mortality associated with surgery.

Below-the-knee angioplasty in patients with end-stage renal disease.

PURPOSE: To determine clinical efficacy of below-the-knee (BTK) angioplasty in patients with end-stage renal disease (ESRD). METHODS: Interrogation of a prospectively maintained database containing 2,659 patients treated at a tertiary referral hospital between February 1995 and June 2004 identified 29 ESRD patients (21 men; median age 69 years, IQR 10.12) who had 73 infrapopliteal atherosclerotic lesions treated in 38 ischemic limbs. The indication for treatment was intermittent claudication in 13 (34%) and critical limb ischemia in 25 (66%) limbs. BTK angioplasty was attempted either alone (n=18) or combined with an endovascular inflow procedure (n=20). Primary clinical success was defined as hemodynamic improvement (ABI increase >or=0.1) and/or symptomatic improvement (at least one clinical category). Cumulative rates were calculated according to the Kaplan-Meier estimate. RESULTS: Primary technical success reached 97%, whereas hemodynamic improvement was obtained in only 50% (19/38) of the limbs treated. The pedal arteries were severely diseased in all, and complete occlusion of the pedal arch was found in 58% (18/31) of limbs on completion angiography. Median follow-up was 5.9 months (IQR 11.5). Primary clinical success was 17%, 11%, 11%, and 11% in patients with BTK angioplasty alone and 53%, 45%, 45%, and 45% in patients with inflow procedures after 3, 6, 9, and 12 months, respectively (p=0.017). Limb salvage was 73% at 12 months. Subgroup analyses showed significantly better clinical results in men (p=0.003) and in patients on hemodialysis compared to peritoneal dialysis (p=0.037). CONCLUSIONS: Clinical efficacy of BTK angioplasty is limited in patients with ESRD because of the severely diseased pedal arteries. Further studies are warranted to define subgroups of patients likely to experience a more favorable outcome.