The clinical trial activation process: a case study of an Italian public hospital.

BACKGROUND/AIMS: In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy). METHODS: A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC). Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials' activation pathway. The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods. The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. RESULTS: In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored. The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored. From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials' activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10). Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46). CONCLUSIONS: The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process. This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.

What's the impact of the obesity on the safety of laparoscopic hysterectomy techniques?

OBJECTIVE: To evaluate the impact of obesity in the safety of laparoscopic hysterectomy. STUDY DESIGN: A retrospective study was conducted using a database of 2271 women undergoing laparoscopic hysterectomy for benign diseases between January 1995 and December 2008 at the Centre Hospitalier Universitaire Estaing (Clermont-Ferrand, France). Patients were divided into two groups according to the body mass index: <30 kg/m(2) (n=2088) and ≥ 30 kg/m(2) (n=183). Primary outcomes were differences in conversion rates, operating time, estimated blood loss, intraoperative complications, and early postoperative complications. RESULTS: There was no difference in the operative time (121.3 versus 122.5 minutes; P=.71), in the difference between pre- and postoperative hemoglobin levels (1.8 versus 1.6 g/dL; P=.28), and in the conversion rate (4.6% versus 5.5%; P=.62) comparing the two groups. The overall intraoperative complication rate was 14.03% (n=293) and 13.66% (n=25) for nonobese and obese patients (P=.89), respectively. The overall postoperative complication rate was 8.81% (n=184) and 7.65% (n=14), respectively. CONCLUSIONS: Obesity does not have an adverse effect on the feasibility and safety of laparoscopic hysterectomy in experienced hands.

Learning experience using the double-console da Vinci surgical system in gynecology: a prospective cohort study in a University hospital.

PURPOSE: To report our preliminary experience with robotic-assisted laparoscopy in a variety of gynecological surgeries in a teaching hospital. METHOD: A total of 33 patients who underwent robotic-assisted laparoscopic procedures for gynecological diseases were included in the study. All surgeries were performed using the double-console da Vinci surgical system. Patient's demographics, surgical procedures, operative time, perioperative complications, conversion rate, hospital stay and estimated blood loss were prospectively collected. RESULTS: All procedures were completed robotically except three (9%): two cases were converted to laparotomy and one case was converted to vaginal surgery. The mean age was 47 ± 11 and mean BMI was 23 kg/m². Mean time taken for docking the robot was 22 min. Mean operative time was 152 min. Mean anesthesia time was 196 min. Mean hemoglobin drop was 2 g/dL. Four complications occurred: one transitory ischemic attack, one port-site hernia managed through trocar incision, one periumbilical hematoma managed conservatively and one vaginal cuff hematoma who required laparoscopy. The mean hospital stay was 4 days. CONCLUSION: With the use of robotic technology, surgeons are able to offer minimally invasive surgery to a larger percentage of patients. Double console system seems a promising tool in surgical education, improving both resident training and participation in surgeries. A shorter adaption to robotics could be expected in teams with previous experience with standard laparoscopy, however, a stepwise start with simpler cases is the key to achieve a safe adaption to robotic surgery.

Uso rutinario del montaje lateral (side-docking) en cirugía robótica ginecológica: estudio de factibilidad / Side docking in gynaecologic robotic surgery: feasibility study

Antecedentes: La mayoría de los estudios publicados en cirugía robótica ginecológica han utilizado el montaje central, con el robot entre las piernas de la paciente. Una desventaja importante de esta técnica es el limitado acceso vaginal. Recientemente, el uso del montaje lateral (robot en 45° respecto a la mesa operatoria) ha permitido obviar esta dificultad. Objetivo: Demostrar la factibilidad del montaje lateral desde el inicio del programa de cirugía robótica en nuestra institución. Método: Estudio de cohorte prospectivo de 22 pacientes consecutivas que optaron por cirugía robótica. Todas las cirugías se realizaron con montaje lateral, recolectando datos demográficos y perioperatorios en cada caso. Resultados: No hubo conversiones a laparotomía o cirugía vaginal. La edad media fue 46 años y el índice de masa corporal medio fue de 26+/-5 kg/m². Los tiempos medios de trócares y montaje fueron 12 +/- 6 y 12 +/- 4 minutos, respectivamente. El tiempo de consola medio fue 111 +/- 60 minutos. Al comparar nuestros primeros 10 casos con el resto, encontramos una disminución significativa en el tiempo de montaje (p=0,03) y el tiempo de consola (p=0,02). Los procedimientos realizados fueron los siguientes: histerectomía (n=18), promonto fijación (n=1), anexectomía (n=1), resección endometriosis (n=1), linfadenectomía pelviana (n=4), linfadenectomía lumbo-aórtica (n=1). Dos pacientes experimentaron complicaciones: una lesión vesical y una perforación intestinal. La estadía hospitalaria media fue 36 horas. Conclusión: El montaje lateral es fácil de adoptar y proporciona un acceso vaginal más adecuado, facilitando la exposición y la extracción de especímenes durante la cirugía robótica ginecológica.

Background: Most of studies on robotic gynaecologic surgery have used traditional docking, with the robot located between the patient's legs. A significant limitation is the limited vaginal access. Recently, side docking with the robot docked at 45° angle to the lower torso has been described. Objective: To report our experience using the side docking since the beginning of our robotic program. Method: 22 consecutive patients who underwent robotic procedures for gynaecological diseases were included. All surgeries were performed using the side-docking. Data collected included demographics, surgical procedures, operative time, complications, conversion rate and hospital stay. Results: All procedures were completed robotically with no conversion. Mean age was 46 years. Mean BMI was 26 +/-5 kg/m². Mean trocar time was 12 +/- 6 minutes and the mean docking time was 12 +/- 4minutes. Mean operative time was 111 +/- 60 minutes. When our first 10 cases were compared with the others we found a statistically significant reduction in docking time (p=0.03) and console time (p=0.02). Surgical procedures were the following: hysterectomy (n=18), sacrocolpopexy (n=1), annexectomy (n=1), endometriosis resection (n=1), pelvic lymphadenectomy (n=4), aortic lymphade-nectomy (n=1). Two complications occurred: a bladder injury and a bowel perforation. Mean hospital stay was 36 hours. Conclusion: Side-docking is easy to learn and improve vaginal access, reduce assistant's fatigue and facilitate specimen retrieval.

Técnica laparoscópica reversa en el manejo quirúrgico de la endometriosis profunda del tabique rectovaginal: experiencia preliminar / Reverse laparoscopic technique in the surgical management of deep endometriosis of the rectovaginal septum: preliminary experience

ANTECEDENTES: El tratamiento quirúrgico de la endometriosis profunda es un procedimiento complejo, asociado a un alto riesgo de complicaciones. Recientemente, el uso de la técnica laparoscópica reversa aparece como una variante técnica interesante con el fin de disminuir las complicaciones. OBJETIVO: Describir nuestra experiencia preliminar y demostrar la factibilidad de la técnica laparoscópica reversa en el tratamiento de la endometriosis profunda del tabique rectovaginal. MÉTODO: Reporte de 5 casos a partir de base de datos prospectiva. RESULTADOS: La edad promedio de las pacientes fue 34,2 años (rango: 32-37 años). Todas las pacientes presentaban dismenorrea y dispareunia profunda de larga evolución y en 3 de ellas existía el antecedente de cirugías previas por endometriosis. El tiempo quirúrgico promedio fue 313 minutos (rango: 180-450 minutos). Todas las cirugías se completaron por laparoscopía y no se registraron complicaciones. La anatomía patológica confirmó endometriosis en todos los casos. El seguimiento promedio fue de 4 meses (rango: 2-8 meses). CONCLUSIÓN: La técnica laparoscópica reversa es una alternativa factible en el manejo quirúrgico de la endometriosis profunda, sin embargo es una técnica compleja y debe ser realizada por equipos experimentados en cirugía laparoscópica.

BACKGROUND: Surgical resection of deep infiltrating endometriosis (DIE) is complex and it is associated with a high risk of complications. Recently, the so-called reverse technique seems to be associated with lower a complication rate when compared to standard technique. AIMS: To report our preliminary experience and the feasibility of reverse technique in the management of DIE. METHOD: Report of 5 cases from a prospective database. RESULTS: Mean age was 34.2 years (range: 32-37 years). All patients had chronic pelvic pain and severe dyspareunia and 3 women had previous surgeries for endometriosis. Mean operative time was 313 minutes (range: 180-450 minutes). All surgeries were completed by laparoscopy and no complications were noted. Histological analysis confirmed endometriosis in all cases. Mean follow-up was 4 months (range: 2-8 month). CONCLUSION: Reverse laparoscopic technique is feasible and reproductible, however, it should be reserved to teams experienced in advanced laparoscopic surgery.

Is laparoscopic hysterectomy feasible for uteri larger than 1000 g?

OBJECTIVE: To evaluate the feasibility of laparoscopic hysterectomy for uteri weighing more than 1000 g. STUDY DESIGN: A retrospective study was conducted in a tertiary center of laparoscopic surgery including 38 women submitted to hysterectomy for uteri weighing more than 1000 g. Patients submitted to open hysterectomy were compared to those submitted to laparoscopic hysterectomy. The primary statistical endpoint was the complication rate. Secondary endpoints were operating time, estimated blood loss, length of hospital stay, and conversion to laparotomy. RESULTS: The patients' mean age was 49.4 years and mean BMI was 25.2 kg/m(2). The surgical intent was laparoscopic hysterectomy in 23 patients (60.5%) and laparotomy in 15 patients (39.5%). Conversion to open surgery was required in 4 patients (17.4%) due to inaccessibility of the pelvis at the beginning of surgery (n=2), technical difficulties during surgery (n=1), and intraoperative bleeding (n=1). One patient in the laparotomy group had an intraoperative ureteral injury. Despite longer operative time (130 vs. 80 min, p=0.002), laparoscopic surgery was associated with reduced length of hospital stay (3 vs. 6 days, p<0.001). Intraoperative bleeding was evaluated by the difference of pre- and post-operative hemoglobin and was equivalent in both groups (2.2 vs. 1.6g/dL; p=0.84). There was a tendency for more postoperative complications in the laparotomic group (33.4% vs. 8.7%; p=0.05). CONCLUSION: Laparoscopic hysterectomy is feasible for selected patients with uteri weighing more than 1000 g.

Surgical outcomes of laparoscopic hysterectomy for enlarged uteri.

STUDY OBJECTIVE: To compare surgical outcomes of laparoscopic hysterectomy for benign diseases according to the uterine weight. DESIGN: Retrospective study (Canadian Task Force classification II-3). SETTING: Teaching and research hospital, a tertiary center. PATIENTS: Women undergoing laparoscopic hysterectomy for benign diseases. INTERVENTIONS: Patients were divided into three groups according to the uterine weight: <250 g (n = 1300), 250 to 500 g (n = 614), and >500 g (n = 178). MEASUREMENTS AND MAIN RESULTS: Primary outcomes were differences in conversion rates, operating time, and blood loss. Secondary outcomes were differences in length of hospital stay, time to first bowel movement, time of bladder catheterization, and complications. Operating time increased according to the uterine weight (116.5 vs 124.1 vs 133 minutes; p <.001). The rate of conversion was statistically higher only for patients with uteri >500 g (3.3% vs 5% vs 13.5%; p <.001). However, the difference between preoperative and postoperative hemoglobin levels was equivalent for the three groups, as well as the overall rates of minor and major intraoperative complications. There was no difference in the time of bladder catheterization, time to first bowel movement, length of hospital stay, and incidence of minor and major postoperative complications among the three groups. CONCLUSION: Despite longer operating time, there is no increase in the intraoperative or postoperative complication rates in those patients with enlarged uteri undergoing laparoscopic hysterectomy. Only conversion is higher in patients with uteri >500 g.

Proximal ectopic pregnancy: a descriptive general population-based study and results of different management options in 86 cases.

OBJECTIVE: To describe different approaches for diagnosis and management of proximal ectopic pregnancies (PP) in general population. DESIGN: Observational population based-study. SETTING: Regional ectopic pregnancy registry. PATIENT(S): Eighty-six PP registered from 1992 to 2008. INTERVENTION(S): Surgical (radical or conservative), medical, or combined therapies. MAIN OUTCOME MEASURE(S): Epidemiologic characteristics, clinical presentation, hCG level, treatments performed, failure rate, and recurrence. RESULT(S): Mean gestational age was 48.2 days. Estimated incidence of PP was 2.7%. Abdominal pain and vaginal bleeding were the commonest symptoms. Two patients were admitted in hypovolemic shock. Diagnostic modalities included transvaginal ultrasound, abdominal ultrasonography, and laparoscopy in 38 (44%), 7 (8%), and 39 (45%) cases, respectively. Mean hCG level was 10,759 IU/L. Thirty-four patients underwent primary cornual resection (39.5%) by laparoscopy (n = 32) or laparotomy (n = 2). Twenty-seven patients (31.4%) underwent primary conservative surgery by laparoscopy: cornuostomy (n = 18) or extended salpigostomy (n = 9). Primary medical treatment with methotrexate was attempted in 14 patients (16.3%). Expectant management was attempted in one case (1.2%). Eleven cases received combined therapies (11.6%). Failure rates for medical and surgical treatments were 35.7% and 28%, respectively. No failures were noted among patients who received combined therapies. CONCLUSION(S): Proximal ectopic pregnancy remains a life-threatening condition. Diagnosis is challenging and requires a high index of suspicion. Despite available conservative strategies, management of PP remains heterogeneous.