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      Diseño y confección del prototipo de un manipulador uterino cubano para realizar la histerectomía totalmente laparoscópica Translated title: Design and manufacture of a Cuban prototype of uterine manipulator for totally laparoscopic hysterectomy

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          Abstract

          El Centro Nacional de Cirugía de Mínimo Acceso de La Habana cuenta con una vasta experiencia, ha realizado 1 107 histerectomías laparoscópicas y cursos de entrenamiento a 132 especialistas del país hasta el año 2012. Con el objetivo de generalizar esta forma de abordar la cirugía del útero, es necesario la utilización de un manipulador el cual se adquiere en el exterior a un costo elevado. Por esta razón los autores se propusieron realizar el diseño y confección de un manipulador uterino nacional. Se realizó un estudio de desarrollo donde se aplicó un cuestionario utilizando la metodología Kano a expertos en la realización de histerectomías totalmente laparoscópicas y el uso del manipulador uterino de Clermont Ferrand, del Centro Nacional de Mínimo Acceso, en el mes de mayo del 2013 para asignar las características deseables del nuevo manipulador uterino. Se diseñó por computadora el manipulador uterino con el programa Solid-Works 2011 y se confeccionó utilizando los materiales óptimos para su esterilización. Los requerimientos deseables asignados fueron, diseño simple, seguro y fácil de armar, menor peso, eje central de forma fija sobre el que se desliza un resaltador vaginal con un tapón de silicona para la oclusión del neumo con un menor costo de sus materiales. El eje central de forma fija dará mayor fuerza de palanca, así como evitará la movilización insuficiente del útero por deslizamiento contrario de la punta del manipulador. El balón inflable vaginal evitará el escape del neumo durante la apertura de la vagina.

          Translated abstract

          The National Center of Minimal Invasive has a wide experience regarding laparoscopic hysterectomies, 1107 of them, and training course for 132 specialists in our country until last 2012 with the main objective of spreading this form of approaching the surgery of the uterus. For this purpose, it is necessary the use of uterine manipulator which must be purchased abroad at a high cost and in not enough quantities as they are required. To carry out the design and making of a national uterine manipulator. A follow-up study was carried out by applying a questionnaire using the Kano methodology to experts in laparoscopic hysterectomy and in the use of the Clermond-Ferrand uterine manipulator in the National Center of Minimal Invasive Surgery in May, 2013. There, the adequate characteristic of the new uterine manipulator were assigned. It was designed in a computer with the Solid-Works 2011 program, and it was made with the right materials for its sterilization. The suitable requirements were: a simple design, an easy and reliable way of assembling, low weight, and a fixed central axis on which a vaginal cap is slid. It has a silicon cap for the closure of the neumo, and less expensive materials were needed. The fixed condition of the central axis will strengthen the lever; moreover, it will avoid the insufficient mobilization of the uterus due to the opposite slide of the manipulator tip.

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          Most cited references28

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          Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials.

          To evaluate the most appropriate surgical method of hysterectomy (abdominal, vaginal, or laparoscopic) for women with benign disease. Systematic review and meta-analysis. Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and Biological Abstracts. Only randomised controlled trials were selected; participants had to have benign gynaecological disease; interventions had to comprise at least one hysterectomy method compared with another; and trials had to report primary outcomes (time taken to return to normal activities, intraoperative visceral injury, and major long term complications) or secondary outcomes (operating time, other immediate complications of surgery, short term complications, and duration of hospital stay). 27 trials (total of 3643 participants) were included. Return to normal activities was quicker after vaginal than after abdominal hysterectomy (weighted mean difference 9.5 (95% confidence interval 6.4 to 12.6) days) and after laparoscopic than after abdominal hysterectomy (difference 13.6 (11.8 to 15.4) days), but was not significantly different for laparoscopic versus vaginal hysterectomy (difference -1.1 (-4.2 to 2.1) days). There were more urinary tract injuries with laparoscopic than with abdominal hysterectomy (odds ratio 2.61 (95% confidence interval 1.22 to 5.60)), but no other intraoperative visceral injuries showed a significant difference between surgical approaches. Data were notably absent for many important long term patient outcome measures, where the analyses were underpowered to detect important differences, or they were simply not reported in trials. Significantly speedier return to normal activities and other improved secondary outcomes (shorter duration of hospital stay and fewer unspecified infections or febrile episodes) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy is preferable to abdominal hysterectomy, although it brings a higher chance of bladder or ureter injury.
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            National learning curve for laparoscopic hysterectomy and trends in hysterectomy in Finland 2000-2005.

            Complications of laparoscopic hysterectomy (LH) have been evaluated with particular focus on quantities of urinary tract injuries. An earlier survey in the 1990s on LH in Finland indicated a decreasing trend in complications; our aim was to evaluate the current complications and hysterectomy trends. All hysterectomies in Finland performed for benign indication from 2000 to 2005 (n = 56 130) were included, data were obtained from the Finnish hospital care register. All major complications reported on LH were analysed; the data were collected retrospectively from the Patient Insurance Centre. In 2000, the proportion of abdominal hysterectomy (AH) was 38%, vaginal hysterectomy (VH) 37% and LH 25%, whereas in 2005, the proportions were 26%, 45% and 29%, respectively. The overall incidence of major complications in LHs from 1992 to 1999 (LH n = 13 885) was 1.8% and from 2000 to 2005 (LH n = 13 942) it decreased to 1.0%. During the same time, urinary tract injuries decreased from 1.4% to 0.7%; in detail ureteral injuries decreased from 0.9% to 0.3%. Laparoscopic and VHs have become more common in Finland than AH. Continuous instruction and training of the Finnish gynaecological surgeons has helped to diminish major complication rates and it seems that in LH, a plateau on the learning curve has been reached.
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              Total laparoscopic hysterectomy: indications, techniques and outcomes.

              The indications, techniques and outcomes of laparoscopic associated hysterectomy and especially total laparoscopic hysterectomy are thoroughly reviewed. The original technique for total laparoscopic hysterectomy is detailed as it is still applicable. The total laparoscopic hysterectomy operation has not changed to any major degree over the past 15 years. The technique detailed works well and lessens the chance for a ureteral injury. Expansion of the technique has occurred in oncology. Evidence-based studies support the use of vaginal hysterectomy if possible over laparoscopic and abdominal hysterectomy. They also support a laparoscopic approach to hysterectomy over total abdominal hysterectomy. Despite evidence-based studies, gynecologic surgical specialists have been slow to adopt both laparoscopic and vaginal hysterectomy into their practice. This trend may increase in the near future. Adoption of laparoscopic associated hysterectomy has been extremely slow.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Journal
                gin
                Revista Cubana de Obstetricia y Ginecología
                Rev Cubana Obstet Ginecol
                Editorial Ciencias Médicas (Ciudad de la Habana )
                1561-3062
                June 2014
                : 40
                : 2
                : 279-292
                Affiliations
                [1 ] Policlínico Integral Docente José Manuel Seguí Jiménez Cuba
                [2 ] Industria Mecánica Caribe Cuba
                Article
                S0138-600X2014000200015
                e68f3fc6-4ac9-4d5e-86a4-024123eefaf4

                http://creativecommons.org/licenses/by/4.0/

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                Product

                SciELO Cuba

                Self URI (journal page): http://scielo.sld.cu/scielo.php?script=sci_serial&pid=0138-600X&lng=en
                Categories
                OBSTETRICS & GYNECOLOGY

                Obstetrics & Gynecology
                uterine manipulator,Kano methodology,neumo-peritoneum,vaginal cap,Clermond-Ferrand,central axis,manipulador uterino,metodología Kano,neumo-peritoneo,resaltador vaginal,Clermont-Ferrand,eje central

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