International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients.

OBJECTIVES: Natural orifice translumenal endoscopic surgery (NOTES) is evolving as a promising alternative for abdominal surgery. IMTN Registry was designed to prospectively document early results of natural orifice surgery among a large group of clinical cases. METHODS: Sixteen centers from 9 countries were approved to participate in the study, based on study protocol requirements and local institutional review board approval. Transgastric and transvaginal endoscopic natural orifice surgery was clinically applied in 362 patients. Intraoperative and postoperative parameters were prospectively documented. RESULTS: Mean operative time for transvaginal cholecystectomy was 96 minutes, compared with 111 minute for transgastric cholecystectomy. A general complication rate of 8.84% was recorded (grade I-II representing 5.8%, grade III-IV representing 3.04%). No requirement for any analgesia was found in one fourth of cholecystectomy and appendectomy patients. CONCLUSIONS: Results of clinical applications of NOTES in the IMTN Study showed the feasibility of different methods of this new minimally invasive alternative for laparoscopic and open surgery.

First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve.

BACKGROUND: We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital. METHODS: The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved. The study included 5 men and 7 women, with a mean body mass index of 43 kg/m(2). Of the 12 patients, 4 had type 2 diabetes. The primary endpoints were the incidence and severity of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in co-morbid status. RESULTS: The DJBS was endoscopically delivered and retrieved in all patients (mean implant/explant time of 26.6 and 43.3 min, respectively). Of the 12 patients, 10 were able to maintain the device for 12 weeks and 2 underwent explantation after 9 days secondary to poor device placement. Several self-limited adverse events were possibly or definitely related to the device, including 6 episodes of abdominal pain, 18 of nausea, and 16 of vomiting, mainly within 2 weeks of implantation. Two partial pharyngeal tears occurred during explantation. Implant site inflammation was encountered in all patients. No device-related event was considered severe. The average percentage of excess weight loss for the 10 patients with the device in place for 12 weeks was 23.6%, with all patients achieving at least 10% excess weight loss. All 4 diabetic patients had normal fasting plasma glucose levels without hypoglycemic medication for the entire 12 weeks. Of these 4 patients, 3 had decreased hemoglobin A(1c) of > or =.5% by week 12. CONCLUSION: The DJBS can be safely delivered and removed endoscopically and left in situ for 12 weeks. The device had a favorable safety and encouraging efficacy profile. Randomized prospective trials are warranted.

FROM COMPLEX EVOLVING TO SIMPLE: CURRENT REVISIONAL AND ENDOSCOPIC PROCEDURES FOLLOWING BARIATRIC SURGERY.

Background: Roux-en-Y gastric bypass (RYGB) is a standard therapy in bariatric surgery. Sleeve gastrectomy and gastric banding, although with good results in the literature, are showing higher rates of treatment failure to reduce obesity-associated morbidity and body weight. Other problems after bariatric may occur, as band erosion, gastroesophageal reflux disease and might be refractory to medication. Therefore, a laparoscopic conversion to a RYGB can be an effective alternative, as long as specific indications for revision are fulfilled. Objective: The objective of this study was to analyse own and literature data on revisional bariatric procedures to evaluate best alternatives to current practice. Methods: Institutional experience and systematic review from the literature on revisional bariatric surgery. Results: Endoscopic procedures are recently applied to ameliorate failure and complications of bariatric procedures. Therapy failure following RYGB occurs in up to 20%. Transoral outlet reduction is currently an alternative method to reduce the gastrojejunal anastomosis. The diameter and volume of sleeve gastrectomy can enlarge as well, which can be reduced by endoscopic full-thickness sutures longitudinally. Dumping syndrome and severe hypoglycemic episodes (neuroglycopenia) can be present in patients following RYGB. The hypoglycemic episodes have to be evaluated and usually can be treated conventionally. To avoid partial pancreatectomy or conversion to normal anatomy, a new laparoscopic approach with remnant gastric resection and jejunal interposition can be applied in non-responders alternatively. Hypoglycemic episodes are ameliorated while weight loss is sustained. Conclusion: Revisional and endoscopic procedures following bariatric surgery in patients with collateral symptomatic or treatment failure can be applied. Conventional non-surgical approaches should have been applied intensively before a revisional surgery will be indicated. Former complex surgical revisional procedures are evolving to less complicated endoscopic solutions.

Racional: Bypass gástrico em Y-de-Roux (BGYR) é procedimento padrão em cirurgia bariátrica. Gastrectomia vertical e banda gástrica, embora com bons resultados na literatura, estão mostrando taxas mais elevadas de insucesso no tratamento para reduzir a morbidade associada à obesidade e peso corporal. Outros problemas pós-operatórios podem ocorrer, como a erosão da banda, e doença do refluxo gastroesofágico refratária à medicação. Portanto, conversão laparoscópica para BGYR pode ser alternativa eficaz, desde que indicações específicas para a revisão sejam cumpridas. Objetivo: Analisar os nossos dados e os da literatura sobre procedimentos bariátricos revisionais para avaliar melhores alternativas para a prática atual. Resultados: Procedimentos endoscópicos estão sendo aplicados recentemente para melhorar a falha e complicações de procedimentos bariátricos. Falha terapêutica após BGYR ocorre em até 20%. A redução transoral é atualmente um método alternativo para reduzir a anastomose gastrojejunal. A gastrectomia vertical pode apresentar aumento de volume e do diâmetro do pouch , o qual podem ser reduzidos por meio de sutura total endoscópica longitudinal. Síndrome de dumping e episódios de hipoglicemia grave (neuroglicopenia) podem estar presentes nos pacientes com BGYR. Os episódios hipoglicêmicos devem ser avaliados e geralmente podem ser tratados convencionalmente. Para evitar pancreatectomia parcial ou conversão à anatomia normal, uma nova abordagem laparoscópica com ressecção do remanescente gástrico e interposição de jejuno, pode ser aplicada como alternativa em não-respondedores. Episódios de hipoglicemia melhoram, enquanto a perda de peso é mantida. Conclusão: Procedimentos revisionais endoscópicos podem ser aplicados após cirurgia bariátrica em pacientes com sintomas colaterais ou na falha do tratamento. Abordagens convencionais não-cirúrgicas devem ser aplicadas intensivamente antes que uma operação revisional seja indicada. Antigos procedimentos cirúrgicos revisionais complexos estão evoluindo para soluções endoscópicas menos complicadas.

FROM COMPLEX EVOLVING TO SIMPLE: CURRENT REVISIONAL AND ENDOSCOPIC PROCEDURES FOLLOWING BARIATRIC SURGERY / EVOLUÇÃO DO COMPLEXO PARA O SIMPLES: PROCEDIMENTOS REVISIONAIS E ENDOSCÓPICOS APÓS CIRURGIA BARIÁTRICA

ABSTRACT Background: Roux-en-Y gastric bypass (RYGB) is a standard therapy in bariatric surgery. Sleeve gastrectomy and gastric banding, although with good results in the literature, are showing higher rates of treatment failure to reduce obesity-associated morbidity and body weight. Other problems after bariatric may occur, as band erosion, gastroesophageal reflux disease and might be refractory to medication. Therefore, a laparoscopic conversion to a RYGB can be an effective alternative, as long as specific indications for revision are fulfilled. Objective: The objective of this study was to analyse own and literature data on revisional bariatric procedures to evaluate best alternatives to current practice. Methods: Institutional experience and systematic review from the literature on revisional bariatric surgery. Results: Endoscopic procedures are recently applied to ameliorate failure and complications of bariatric procedures. Therapy failure following RYGB occurs in up to 20%. Transoral outlet reduction is currently an alternative method to reduce the gastrojejunal anastomosis. The diameter and volume of sleeve gastrectomy can enlarge as well, which can be reduced by endoscopic full-thickness sutures longitudinally. Dumping syndrome and severe hypoglycemic episodes (neuroglycopenia) can be present in patients following RYGB. The hypoglycemic episodes have to be evaluated and usually can be treated conventionally. To avoid partial pancreatectomy or conversion to normal anatomy, a new laparoscopic approach with remnant gastric resection and jejunal interposition can be applied in non-responders alternatively. Hypoglycemic episodes are ameliorated while weight loss is sustained. Conclusion: Revisional and endoscopic procedures following bariatric surgery in patients with collateral symptomatic or treatment failure can be applied. Conventional non-surgical approaches should have been applied intensively before a revisional surgery will be indicated. Former complex surgical revisional procedures are evolving to less complicated endoscopic solutions.

RESUMO Racional: Bypass gástrico em Y-de-Roux (BGYR) é procedimento padrão em cirurgia bariátrica. Gastrectomia vertical e banda gástrica, embora com bons resultados na literatura, estão mostrando taxas mais elevadas de insucesso no tratamento para reduzir a morbidade associada à obesidade e peso corporal. Outros problemas pós-operatórios podem ocorrer, como a erosão da banda, e doença do refluxo gastroesofágico refratária à medicação. Portanto, conversão laparoscópica para BGYR pode ser alternativa eficaz, desde que indicações específicas para a revisão sejam cumpridas. Objetivo: Analisar os nossos dados e os da literatura sobre procedimentos bariátricos revisionais para avaliar melhores alternativas para a prática atual. Métodos: Foram efetuados experiência institucional e revisão sistemática da literatura sobre cirurgia bariátrica revisional. Resultados: Procedimentos endoscópicos estão sendo aplicados recentemente para melhorar a falha e complicações de procedimentos bariátricos. Falha terapêutica após BGYR ocorre em até 20%. A redução transoral é atualmente um método alternativo para reduzir a anastomose gastrojejunal. A gastrectomia vertical pode apresentar aumento de volume e do diâmetro do pouch , o qual podem ser reduzidos por meio de sutura total endoscópica longitudinal. Síndrome de dumping e episódios de hipoglicemia grave (neuroglicopenia) podem estar presentes nos pacientes com BGYR. Os episódios hipoglicêmicos devem ser avaliados e geralmente podem ser tratados convencionalmente. Para evitar pancreatectomia parcial ou conversão à anatomia normal, uma nova abordagem laparoscópica com ressecção do remanescente gástrico e interposição de jejuno, pode ser aplicada como alternativa em não-respondedores. Episódios de hipoglicemia melhoram, enquanto a perda de peso é mantida. Conclusão: Procedimentos revisionais endoscópicos podem ser aplicados após cirurgia bariátrica em pacientes com sintomas colaterais ou na falha do tratamento. Abordagens convencionais não-cirúrgicas devem ser aplicadas intensivamente antes que uma operação revisional seja indicada. Antigos procedimentos cirúrgicos revisionais complexos estão evoluindo para soluções endoscópicas menos complicadas.