The EURO-NOTES clinical registry for natural orifice transluminal endoscopic surgery: a 2-year activity report.

BACKGROUND: The EURO-NOTES Clinical Registry (ECR) was established as a European database to allow the monitoring and safe introduction of Natural Orifice Transluminal Endoscopic Surgery (NOTES). The aim of this study was to analyze different techniques applied and relative results during the first 2 years of the ECR. METHODS: The ECR was designed as a voluntary database with online access. All members of the European Society for Gastrointestinal Endoscopy and the European Association for Endoscopic Surgery were requested to participate in the registry. Demographic and therapy data as well as data on the postoperative course are recorded in the ECR in an anonymous way. RESULTS: A total of 533 patients who underwent NOTES procedures were included in the study. Four different hybrid techniques for 435 cholecystectomies were described, registering postoperative complications in 2.8% of patients, addition of a single trocar in 5.3%, and conversions to laparoscopy in 0.5%. Both flexible endoscopic and rigid laparoscopic cholecystectomy techniques proved to be safe and effective with minor differences. There was a shorter operative time in the rigid laparoscopic group. Thirty-three appendectomies were reported by transgastric and transvaginal techniques, with transvaginal techniques scoring shorter operative time and hospital stay, but with a frequent need to add more trocars. Overall complications occurred in 14.7% of patients but they did not differ significantly among the different techniques. One transvaginal and 31 transanal sigmoidectomies were included for prolapse and diverticulitis, with four postoperative complications (12.5%), but none needing further treatment. Twenty peroral esophageal myotomies were included with three postoperative complications (15.0%), but none needing further treatment. CONCLUSIONS: Five years since the introduction of NOTES into clinical practice, hybrid techniques have gained considerable clinical application. Several NOTES hybrid cholecystectomy and appendectomy techniques are practicable and safe alternatives to laparoscopic procedures. Also, sigmoidectomies and peroral esophageal myotomies were described, proving feasibility and safety. Nevertheless, the real benefit of NOTES for patients still needs to be assessed.

Transanal endoscopic microsurgery in treatment of rectal adenomas and T1 low-risk carcinomas.

BACKGROUND: Transanal endoscopic microsurgery as a local therapy option for rectal neoplasms is a tissue-sparing technique that protects the anal sphincter. The present retrospective analysis reports the course of observation after local excision of adenomas and T1 low-risk carcinomas using transanal endoscopic microsurgery. METHODS: In a retrospective analysis we examined data on 279 patients for local recurrence. A total of 144 patients had a rectal adenoma (n = 103) or a R0 resection of low-risk T1 carcinomas (n = 41). In this collective, we also examined parameters concerning perioperative management, complications, intraoperative blood loss and duration of hospital stay. RESULTS: Patients with adenoma were on average 64.9 (range 37 to 90) years old; 83.5% of the adenomas were located 3 to 11 cm from the anocutaneous line. In adenoma patients the recurrence rate was 2.9% for an observation period of 21.8 months. The postoperative course was without any complications in 98.1% of patients.Patients with T1 low-risk carcinoma were 64.6 (range 30 to 89) years old. In all cases, an R0 resection could be performed. The recurrence rate was 9.8% for an observation period of 34.4 months. In this group the postoperative course was free of complications in 97.6% of patients. CONCLUSIONS: The high efficacy of transanal endoscopic microsurgery ensures minimally invasive treatment of adenomas and low-risk T1 carcinomas with low complication rates and a low rate of therapeutic failure.

3D HD versus 2D HD: surgical task efficiency in standardised phantom tasks.

BACKGROUND: Common video systems for laparoscopy provide the surgeon a two-dimensional image (2D), where information on spatial depth can be derived only from secondary spatial depth cues and experience. Although the advantage of stereoscopy for surgical task efficiency has been clearly shown, several attempts to introduce three-dimensional (3D) video systems into clinical routine have failed. The aim of this study is to evaluate users' performances in standardised surgical phantom model tasks using 3D HD visualisation compared with 2D HD regarding precision and working speed. METHODS: This comparative study uses a 3D HD video system consisting of a dual-channel laparoscope, a stereoscopic camera, a camera controller with two separate outputs and a wavelength multiplex stereoscopic monitor. Each of 20 medical students and 10 laparoscopically experienced surgeons (more than 100 laparoscopic cholecystectomies each) pre-selected in a stereo vision test were asked to perform one task to familiarise themselves with the system and subsequently a set of five standardised tasks encountered in typical surgical procedures. The tasks were performed under either 3D or 2D conditions at random choice and subsequently repeated under the other vision condition. Predefined errors were counted, and time needed was measured. RESULTS: In four of the five tasks the study participants made fewer mistakes in 3D than in 2D vision. In four of the tasks they needed significantly more time in the 2D mode. Both the student group and the surgeon group showed similarly improved performance, while the surgeon group additionally saved more time on difficult tasks. CONCLUSIONS: This study shows that 3D HD using a state-of-the-art 3D monitor permits superior task efficiency, even as compared with the latest 2D HD video systems.

Single-port surgery and NOTES: from transanal endoscopic microsurgery and transvaginal laparoscopic cholecystectomy to transanal rectosigmoid resection.

Two different ways have been developed to perform endoscopic surgery. The standard way is multiport laparoscopic surgery. When entering through a natural orifice, we use single-port surgery for transanal work (transanal endoscopic microsurgery). In clinical routine, we moved from intralumenal surgery toward surgery in the perirectal area and finally the free abdomen. In the context of natural orifice translumenal endoscopic surgery, we have modified the length and diameter of optics and tube and developed new mechanisms for steering long curved instruments. This technology is then used for transvaginal cholecystectomy and transanal rectosigmoid resection. Global clinical application of transanal endoscopic microsurgery has proven superiority in preciseness and clinical results for adenomas and early cancer. The initial clinical study for transvaginal cholecystectomy is successfully performed in 6 female patients with an average operation time of 80 minutes and without major complication. Feasibility of transanal rectosigmoid resection is demonstrated in an ex vivo experimental model.

A novel single-port technique for transanal rectosigmoid resection and colorectal anastomosis on an ex vivo experimental model.

BACKGROUND: In the context of natural orifice translumenal endoscopic surgery (NOTES), we developed a new set of rigid instruments according to the principles of transanal endoscopic microsurgery (TEM).These instruments are long, curved, and steerable by rotating two wheels near its handle. Our success in transvaginal cholecystectomy in human with these instruments motivated us to explore the feasibility of rectosigmoid resection through the anus. METHODS: The young bovine large bowel with attached organs is collected en bloc and reintegrated into an anatomically designed trainer to reproduce the human anatomy. The technique comprises the following: (1) closure of the rectal lumen by an endolumenal pursestring suture; (2) transection of the rectal wall 1 cm distal to the pursestring suture and continuation of the dissection toward the fascia and upward excising the mesorectal tissue; (3) inferior mesenteric artery is divided near its origin; (4) the colon is mobilized up to the splenic flexure; (5) the mobilized colon is brought down to the pelvis, ligated twice at the intended proximal resection site, and divided between the ligatures; (6) specimen is delivered transanally; and (7) intestinal continuity is restored by stapled or hand-sutured anastomosis. RESULTS: Twelve rectosigmoid resections, 20 stapled, and 27 hand-sutured anastomoses were performed in two experimental setups. Mean operation time for the resection part was 78.6 min (standard deviation (SD)=9.9). The average specimen length was 37.2 cm. During dissection in the pelvis, as the specimen was pushed upward and toward abdomen, an "empty pelvis" view of the working field was achieved, facilitating dissection. The mean operation time for hand-sutured and stapled anastomoses were 47.7 (SD=6.9) and 43.3 (SD=7.1) min, respectively. Both groups had one anastomotic leak. CONCLUSIONS: Transanal rectosigmoid resection is feasible with TEM technology. The unobstructed "empty pelvis" view is likely to enhance the quality of mesorectal dissection.

Artificial tactile feedback can significantly improve tissue examination through remote palpation.

BACKGROUND: In laparoscopy, impaired feedback information from the operation site and reduced instrument dexterity lead to high demands on surgeons' skill and experience. Pre-clinical studies have shown that artificial tactile feedback (ATF) could significantly improve the quality of tactile feedback information. Additional information about interaction effects of tissue features when using ATF as well as related detection thresholds would be valuable for drawing conclusions on possible clinical application scenarios. OBJECTIVE: To identify surgical procedures in laparoscopy that could benefit from ATF in tissue examination through remote palpation. METHODS: We have developed a laparoscopic grasper capable of providing ATF by measuring the pressure distribution on one forceps jaw with a tactile sensor array. The data was presented graphically on the endoscopic screen. We conducted a study among surgeons and non-surgeons, comparing the capability to detect hidden objects through remote palpation with and without ATF. The data were analyzed using repeated-measures multiple analysis of variance (MANOVA) in two designs. RESULTS: ATF could enhance feedback information with significant positive effects on accuracy, speed, the reduction of the number of grasps, and user confidence. The positive effect of ATF turned out to be especially strong if hidden objects were either hard and too small or large and too soft to be recognized by remote palpation without ATF. CONCLUSIONS: Our study contributes to the discussion on promising application scenarios of ATF-enhanced instrumentation in laparoscopic surgery. Based on our study results, such instrumentation may be valuable for detection and examination of hidden bodies or structures through remote palpation.

EAES recommendations on methodology of innovation management in endoscopic surgery.

BACKGROUND: Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness. METHODS: An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon. RESULTS: The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given. CONCLUSIONS: Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

Review on aspects of artificial tactile feedback in laparoscopic surgery.

Since direct manual tissue palpation is not possible in laparoscopic surgery, feedback information on tactile tissue properties is considerably diminished. Restoring part of the surgeon's sense of touch through devices capable of providing artificial tactile feedback (ATF) is an active field of applied research and development. Despite more than two decades of research, technical development of such devices is still basic, and pre-clinical as well as clinical experience is limited. This article provides an overview of the technological aspects of ATF in laparoscopic surgery, gives background information on principles of human perception of related feedback information, and reviews current research attempts in the field of ATF systems in laparoscopic surgery, broken down into three main system components: tactile sensor, display, and data processing. Tactile sensors have been developed to measure tissue compliance, reveal hidden structures or foreign bodies in tissue through measurement of pressure distribution, and to identify and locate arteries by detecting their pulsation. Furthermore, different solutions for presenting tactile data to the surgeon have been developed. Visual and auditory displays are easy to implement into the operating room equipment, while tactile displays still suffer from difficulties concerning their performance and requirements for clinical usability. The role of the data processing system as the linking component in an artificial tactile feedback system has been identified as crucial for effectiveness of the system and easy reception of tactile data by the surgeon. The investigations on theoretical and technological foundations of ATF have led to an extensive database in recent years. An application-driven development approach will likely be a driving factor in the future evolution of this field.

Microcirurgia endoscópica transanal no tratamento dos tumores do reto: estudo prospectivo em 50 pacientes / Transanal endoscopic microsurgery in the treatment of rectal tumors: a prospective study in 50 patients

RACIONAL: A literatura médica aceita ressecção local como opção válida em casos selecionados de tumores de reto. A seleção dos pacientes requer exata estimativa dos riscos e avaliação pré-operatória precisa, tanto no aspecto clínico como histopatológico. OBJETIVO: Avaliar os resultados da microcirurgia endoscópica transanal em seguimento de 18 meses. MÉTODOS: De abril de 2002 a abril de 2006, 50 pacientes com tumores de reto foram submetidos a microcirurgia endoscópica transanal, selecionados por suas características clínicas e histopatológicas. Os critérios de inclusão foram: adenomas sésseis maiores do que 3 cm e menores do que 8 cm não-circunferenciais; neoplasia intra-epitelial de alto grau; carcinoma retal pT1, e em casos especiais pT2. Todos esses tumores foram submetidos ao mesmo procedimento cirúrgico. RESULTADOS: O resultado histopatológico final revelou 9 adenomas, 26 neoplasias intra-epiteliais de alto grau, 13 carcinomas (9 pT1 e 4 pT2) e 2 carcinóides. A menor idade foi de 25 anos e a maior de 92. O menor tumor ressecado tinha 64 mm² (carcinóide) e o maior (adenoma) 90 mm². O tempo médio de operação foi de 90 minutos e o de internamento 5 dias. Houve uma morte não relacionada ao método. Um paciente com carcinoma de baixo risco pT1 apresentou recidiva 18 meses após microcirurgia endoscópica transanal e foi submetido a retossigmoidectomia curativa. Foi observado tumor residual em dois pacientes e a complicação mais grave foi uma fístula retovaginal. A taxa de complicação global foi de 9 por cento. CONCLUSÃO: Atualmente a microcirurgia endoscópica transanal é a técnica de escolha para o tratamento de adenomas sésseis, neoplasias intra-epiteliais de alto grau e carcinoma retal pT1 de baixo risco.

BACKGROUND: The medical literature accepts local resection as a valuable option in selected cases of rectal tumors. Selection of patients requires an exact perioperative estimation of risks with clinical and histopathological examination. Transanal endoscopic microsurgery aims a safe resection of the tumoral area which leads up to the cure. AIM: To evaluate transanal endoscopic microsurgery results in a follow-up time of 18 months. METHODS: From April 2002 to April 2006, 50 patients with rectal tumors were submitted to transanal endoscopic microsurgery, chosen by clinical history and lesion characteristics. The inclusion criteria were: sessile adenomas larger than 3 cm and smaller than 8 cm, not circumferentially distributed; intra epithelial neoplasia of high degree; and rectal carcinoma pT1, and special cases of pT2. All these rectal tumors were submitted to the same surgical act. RESULTS: The final histopathological results reveal 9 adenoma, 26 intra-epithelial neoplasia of high degree, 13 carcinoma (9 pT1-4 pT2) and 2 carcinoid. The lowest age was 25 and the higher, 92 years-old. The smallest resected tumor had 64 mm² (carcinoid) and the largest (adenoma), 90 cm². Operating time was in average 90 minutes and the overall time statement, 5 days. There was one death not related with the method. One patient with low risk carcinoma pT1 presented recurrence 18 months after transanal endoscopic microsurgery and was submitted to curative rectosigmoidectomy. It was proven a residual tumor after local surgery in two patients and the most important complication was one recto-vaginal fistula. The overall complications rate was 9 percent. CONCLUSION: Today transanal endoscopic microsurgery is chosen as the ideal technique for the treatment of sessile adenomas, intraepithelial neoplasia of high degree and rectal carcinoma pT1.

Instruments for transluminal laparoscopic surgery or "NOTES".

The first endoluminal operation ever developed was transanal endoscopic microsurgery (TEM), years before laparoscopic cholecystectomy was first performed. Numerous procedures using its single port system (SPS) have since been done and it is now a well-established technique in colorectal surgery around the world. There are some advantages of SPS over multiple port surgery. In 2005 we expanded on the concept of single port surgery with rigid instruments and started to develop instruments for transvaginal single port laparoscopic surgery. We now describe the instruments and system, which include devices that permit a safe access to the abdominal cavity, optimal endoscopic view and instrument steering and a precision that is not reached by current flexible technologies. The devices have been put to the test in an experimental model of transvaginal cholecystectomy. The potential benefits of the technique and the new instruments are discussed.

[Experimental study on a new method for colonoscopic closure of large-bowel perforations with the OTSC clip]. / Experimentelle Untersuchung zu einem neuen Verfahren für den koloskopischen Verschluss von Dickdarmperforationen mit dem OTSC-clip.

Iatrogenic perforation of the colon during interventional endoscopic procedures, e.g., mucosectomy, is a problematic complication, as safe treatment often requires surgical repair. Iatrogenic perforation of the colon is indeed a rare complication; however, given the increasing case numbers in interventional endoscopy it is of considerable practical relevance. The closure of perforations can be achieved with conventional endoscopic clips; however, these working channel based clips are often too small to close a perforation securely. Therefore, we have developed a novel endoscopic clipping system that can be attached to the tip of the endoscope. This over-the-scope-clip system (OTSC), made of Nitinol, was tested in an experimental trial (domestic pig, 50-60 kg) for its applicability for perforation closure. In acute experiments, tight endoscopic closure of 10 perforations in five animals was demonstrated; perforations were made through repeat biopsy. In three further animals, the postoperative course was studied over a period of 2 weeks. Peritonitis was not found in any of these animals. The local healing result at the site of implantation was good. Clips were present 2 weeks after the procedure. In this experimental study, the OTSC clip system was found to be a simple and secure method of iatrogenic colon perforation closure.

Transanal endoscopic microsurgery (TEM) in the treatment of postoperative colorectal stenosis / Microcirurgia endoscópica transanal (TEM) no tratamento de estenose colorretal pós-operatória

BACKGROUND: Strictures of low colorectal anastomosis are increasing by use the anastomotic stapler. There are many kinds of treatments like dilation, transanal rectotomy, and resection with linear or circular stapler. Other methods includes endoscopic knifes, absorbable sutures and laparotomy. The Transanal Endoscopic Microsurgery (TEM) has been used to treat postoperative anastomotic stenosis. CASES REPORT: Three cases of anastomotic strictures after low colorectal anastomosis were treated with TEM with success in medium follow-up. They had a good postoperative evolution without recurrence of symptoms and stenosis. CONCLUSION: The new TEM surgical approach seems to be a safe choice for the treatment of the postoperative colorectal stenosis.

INTRODUÇÃO: Estenoses de anastomoses colônicas baixas estão sendo mais relatadas devido ao maior uso de anastomoses mecânicas. Existem vários processos de tratamento como dilatações, retotomia transanal e ressecções com re-anastomoses mecânicas. Outros métodos incluem secções endoscópicas, secções com anastomoses com suturas absorvíveis e laparotomia. A Microcirurgia Endoscópica Transanal (TEM) está sendo proposta para o tratamento das estenoses anastomóticas. RELATO DOS CASOS: Três casos de estenoses anastomóticas foram tratados pela TEM com bom resultado em relação ao seguimento a médio prazo sem recurrência de sintomas. CONCLUSÃO: A TEM parece ser boa opção para o tratamento das estenoses resultantes das anastomoses coloretais baixas.

The OTSC clip for endoscopic organ closure in NOTES: device and technique.

The closure of the gastrotomy in Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a prerequisite for transgastric endoscopic procedures in the abdominal cavity. Different techniques have been proposed and are under experimental or early clinical investigation. We describe the technique of using an over-the-scope-clip system (OTSC), made of super-elastic Nitinol and a specially designed tissue-approximating double jaw endoscopic grasper for gastric closure. The OTSC is a clipping system mounted at the tip of the endoscope and is used for the treatment of gastrointestinal bleeding or gastrointestinal organ perforations. An enlarged version of the OTSC is now under investigation for NOTES. The closure procedure consists of two steps. First the margins of the perforation are approximated by means of an endoscopic grasper that has two mobile and one fixed jaw, thus providing two independent tissue grasping areas. Each half of this twin grasper is used to grasp one side of the perforation wound margins. Then the margins are approximated and pulled towards the OTSC cap at the tip of the scope. Then the clip is released and the access hole is closed by compression. The OTSC clip can be applied for organ closure in NOTES in experimental studies. The technique allows closing the access site from inside the gastric cavity without leaving material on the peritoneal surface of the organ.

Development of a transoral fundoplication device and related experimental research.

This paper describes a device and surgical techniques developed between 1999 and 2003 to enable an entirely transoral approach to fundoplication. The Endofundoplication System (EFS) system consisted of a multifunctional flexible tube for oral introduction (18 mm) as the key component, with a specially designed retroverted grasper that was used to grasp the lower esophageal sphincter (LES) area of the esophagus, for invaginating the LES into the stomach and folding the gastric wall onto the wall of the intraabdominal esophagus. The EFS system was finally studied in a consecutive series of animal experiments in the domestic pig (n = 10). In nine out of the ten cases the procedure could be successfully completed and the animals survived six weeks according to the study protocol. The clinical follow-up of the nine animals went without problems. The animals behaved normally the first day after the procedure and tolerated regular diet very well. No signs of pain or any abdominal pathology were found in the clinical follow-up. Follow-up by endoscopy and fluoroscopy showed a subsequent postoperative migration of fasteners within the tissue. After autopsy and macroscopic inspection of the gastroesophageal junction (GEJ), we found firm tissue indurations around the fasteners. This may indicate that the fastener as a foreign body leads to a sufficient amount of scar tissue formation to contribute to permanent fixation of the tissue layers. The basic advantage of the EFS technique was seen by our group in the fact that it comes closer to the shape and function of a classical fundoplication than any other techniques proposed at the time we did our development. The nipple valve created by the EFS technique is, however, geometrically not identical to any existing fundoplication technique and is not directly comparable to any such procedure.

[Transanal endoscopic microsurgery in the treatment of rectal tumors: a prospective study in 50 patients]. / Microcirurgia endoscópica transanal no tratamento dos tumores do reto: estudo prospectivo em 50 pacientes.

BACKGROUND: The medical literature accepts local resection as a valuable option in selected cases of rectal tumors. Selection of patients requires an exact perioperative estimation of risks with clinical and histopathological examination. Transanal endoscopic microsurgery aims a safe resection of the tumoral area which leads up to the cure. AIM: To evaluate transanal endoscopic microsurgery results in a follow-up time of 18 months. METHODS: From April 2002 to April 2006, 50 patients with rectal tumors were submitted to transanal endoscopic microsurgery, chosen by clinical history and lesion characteristics. The inclusion criteria were: sessile adenomas larger than 3 cm and smaller than 8 cm, not circumferentially distributed; intra epithelial neoplasia of high degree; and rectal carcinoma pT1, and special cases of pT2. All these rectal tumors were submitted to the same surgical act. RESULTS: The final histopathological results reveal 9 adenoma, 26 intra-epithelial neoplasia of high degree, 13 carcinoma (9 pT1-4 pT2) and 2 carcinoid. The lowest age was 25 and the higher, 92 years-old. The smallest resected tumor had 64 mm(2) (carcinoid) and the largest (adenoma), 90 cm(2). Operating time was in average 90 minutes and the overall time statement, 5 days. There was one death not related with the method. One patient with low risk carcinoma pT1 presented recurrence 18 months after transanal endoscopic microsurgery and was submitted to curative rectosigmoidectomy. It was proven a residual tumor after local surgery in two patients and the most important complication was one recto-vaginal fistula. The overall complications rate was 9%. CONCLUSION: Today transanal endoscopic microsurgery is chosen as the ideal technique for the treatment of sessile adenomas, intraepithelial neoplasia of high degree and rectal carcinoma pT1.

Custo comparado da Microcirurgia Endoscópica Transanal (TEM) com a retossigmoidectomia anterior e com a cirurgia de amputação abdômino-perineal do reto / Comparative cost among Transanal Endoscopic Microsurgery (TEM), anterior resection and Miles procedure

RACIONAL: A Microcirurgia Endoscópica Transanal (TEM) corresponde a um dos mais recentes avanços no tratamento para lesões retais benignas e malignas. OBJETIVO: Determinar o custo da TEM no Hospital de Clínicas da Universidade Federal do Paraná, comparando-o ao da amputação abdômino-perineal do reto e da retossigmoidectomia anterior, estabelecendo parâmetros de custo-efetividade no âmbito do Sistema Único de Saúde. MÉTODOS: Estudo observacional, prospectivo e de coorte da avaliação dos custos dos três procedimentos cirúrgicos citados, enfocando gastos laboratoriais, com medicamentos e internação. Foram incluídos 74 pacientes, 27 submetidos à TEM, 29 à retossigmoidectomia anterior e 18 à amputação abdômino-perineal. RESULTADOS: Com relação à idade, não se observa diferença estatisticamente significativa entre os grupos. O grupo da TEM apresentou o menor tempo de internação (5,51 dias) comparado à retossigmoidectomia anterior (20,41) e à amputação abdômino-perineal (18,33). Quando se consideram os custos laboratoriais, de medicamentos e de diárias hospitalares, observam-se diferenças significantes entre os três procedimentos com custo muito inferior no grupo da TEM, cerca de 2,5 a 4 vezes menor na comparação global (R$ 1.326,71 vs R$ 5.427,16 vs R$ 4.310,20, respectivamente). CONLUSÃO: As vantagens da TEM se mostram evidentes no que tange a custos de internação e permanência hospitalar, com redução significativa quando comparado às técnicas convencionais.

BACKGROUND: Transanal Endoscopic Microsurgery (TEM) corresponds to one of the most recent advances in treating bening and malignant rectal lesions. AIM: To determine the cost of TEM at the Hospital de Clínicas of the Federal University of Paraná, and compare it to the cost of a perineal-abdominal amputation of the rectum and of an anterior rectosigmoidectomy, therefore establishing cost-effective parameters with regards to the "Sistema Único de Saúde”. METHODS: Observational and prospective study pertaining cost evaluation of the three surgical procedures pointed above, focusing on laboratory expenses with drugs and hospitalization. Seventy four patients were included in the study, and of these 27 were submitted to TEM, 29 to anterior rectosigmoidectomy and 18 to perineal-abdominal amputation of the rectum. RESULTS: With regards to age, no significant statistical difference was observed. The group who underwent TEM presented the lowest admission period (5,51 days) when compared to the anterior rectosigmoidectomy (20,41) and to the perineal-abdominal amputation of the rectum (18,33). With regards to laboratory expenses, drug and hospital daily rates, significant statistical differences were observed between the three surgical procedures. The TEM group had the lowest cost, approximately 2.5 to four times smaller in the overall comparison (R$ 1,326.71 vs R$ 5,427.16 vs R$ 4,310.20 respectively). CONCLUSION: TEM advantages are evident through admission and hospital stay costs, with significant reduction when compared to conventional techniques.

Qualidade de vida do paciente submetido à Microcirurgia Endoscópica Transanal (TEM) / Quality of life after Transanal Endoscopic Microsurgery (TEM)

RACIONAL: A Microcirurgia Endoscópica Transanal (TEM) é procedimento minimamente invasivo para o tratamento de tumores retais selecionados. Atualmente, existe crescente interesse médico na medida quantitativa da qualidade de vida. OBJETIVO: Avaliar a qualidade de vida dos pacientes submetidos a TEM no Serviço de Cirurgia do Aparelho Digestivo no Hospital de Clínicas da Universidade Federal do Paraná. MÉTODOS: Trata-se de um estudo observacional prospectivo e de coorte da avaliação da qualidade de vida após TEM. Trinta e quatro pacientes responderam a um questionário composto de 14 questões, abordando aspectos pós-operatórios e laborais. Dirigiam-se elas para levantar dados principalmente sobre: o consentimento informado; a dor experimentada após a operação; a capacidade de o paciente caminhar no período pós-operatório; o período para retorno às atividades habituais; a satisfação com a ausência de cicatriz pós-operatória; a incontinência no pós-operatório; se recomendaria a operação a um familiar ou conhecido. RESULTADOS: Todos os 34 pacientes relataram ter sido adequadamente informados sobre o procedimento. Ausência de dor pós-operatória foi observada em 82,5% e todos se mostraram capazes de deambular no 1º dia do pós-operatório. O retorno às atividades habituais deu-se em média sete dias após o procedimento. Somente cinco pacientes (14,70%) apresentaram incontinência fecal transitória, não maior que uma semana. Três pacientes (8,82%) necessitaram de re-internação, sendo dois por tumores residuais e outro por recidiva tumoral. Dois pacientes (5,88%) referiram modificação temporária na vida sexual após a cirurgia e 97,05% indicariam a TEM a um familiar ou amigo. O período médio de internação foi de três dias. CONCLUSÃO: Os pacientes apresentaram boa evolução, com pouca dor pós-operatória, curto período de internação e baixo índice de complicações, mostrando satisfação e adequada qualidade de vida com a TEM.

BACKGROUND: Transanal Endoscopic Microsurgery (TEM) is a minimal invasive procedure for the treatment of rectal tumors. Nowadays there has been an increasing medical interest regarding quantitative measurements pertaining quality of life. AIM: To evaluate life quality of patients submitted to TEM at Hospital de Clínicas of the Federal University of Paraná in the Department of Surgery of the Digestive Tract. METHODS: A prospective observational cohort study was done to evaluate the quality of life after TEM. Thirty-four patients answered a questionnaire composed of 14 questions concerning postoperative and labor issues. Questions concerned primarily about: informed consent; pain felt after surgery; patients capacity to walk during the postoperative state; period of return to normal activities; satisfaction regarding the absence of postoperative scars; postoperative incontinence, as well as the recommendation of this surgery to family members or friends. RESULTS: All thirty-four patients claimed to be adequately informed about the procedure. The absence of postoperative pain was observed in 82.5 %, and all demonstrated the capacity to walk in the first postoperative day. In average, returning to normal activities began after the seventh day of surgery. Only five patients (14.70%) experimented transitory fecal incontinence, enduring no longer than a week. Three patients (8.82%) were later readmitted to the hospital: two with residual tumors and the other for tumor recurrence. Two patients (5.88%) complained about temporary modification in his/her sexual life after the surgery, and 97.05% would indicate TEM for his/her family members or friends. The average time period of admission was of three days. CONCLUSION: Patients presented a good evolution, with little postoperative pain, and a low complication index, demonstrating satisfactory and adequate quality of life after TEM.

The radius surgical system - a new device for complex minimally invasive procedures in urology?

OBJECTIVE: Complex laparoscopic procedures in urology are technically demanding with an extended learning curve. Robotic systems add significant cost to laparoscopic procedures. We therefore evaluated the use of the Radius Surgical System (RSS), a mechanical manipulator, for complex laparoscopic cases in urology. MATERIAL AND METHODS: The RSS (Tuebingen Scientific) consists of two hand-guided surgical manipulators and provides a deflectable and rotatable tip allowing six degrees of freedom. We evaluated the system by using a series of standardized models in the pelvitrainer. We analyzed the effectiveness of the system and the learning curve. We then evaluated the system in the clinical setting during laparoscopic radical prostatectomy. RESULTS: Surgeons with experience on the RSS were compared to surgeons without previous experience on the system. We identified a learning curve in those participants without experience on the system only when performing complete anastomoses in the pelvitrainer. However, this learning curve included less than 10 anastomoses. The first clinical experiences during laparoscopic extraperitoneal radical prostatectomy (n=10) are promising. All anastomoses were patent on routine (X-ray) examination 8 days after surgery. CONCLUSIONS: The RSS system is easy to use and we identified a very short learning curve. We now optimize the system for use in urology. This device may facilitate complex laparoscopic procedures without the use of costly robotic systems and should be further evaluated in the experimental and clinical setting.