Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial
Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions.
Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would
- realize the benefits of less invasive surgery by reducing the recovery time,
- experience less physical discomfort associated with traditional procedures
- have virtually no visible scarring following this type of surgery.
All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care.
The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).
Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis.
Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.
Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Durango, México, 34000
- Universidad Juarez del Estado de Durango, Mexico
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adult (> 18 years old) female patients residents of Durango Mexico.
- Patients who undergo elective surgery.
- Patients with ultrasound documented symptomatic cholelithiasis, gallbladder polyps of biliary dyskinesia.
- Patients capable of giving written informed consent for the study.
Exclusion Criteria:
- Patients who have contraindications prohibiting general anesthesia.
- Pregnancy.
- Previous abdominal or gynecological procedures.
- Uncontrollable medical or psychiatric conditions
- Elderly > 65 y/o.
- Body Mass Index > 35 mg/kg2.
- Complicated or acute cholecystitis.
- Elevation of liver function tests.
- Acute abdomen.
- Intra-abdominal abscess.
- Coagulopathy.
- Imperforated hymen.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
Transvaginal NOTES Cholecystectomy (Phase 1)
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Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
Outros nomes:
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Comparador Ativo: 2
Laparoscopic Cholecystectomy (Phase 2)
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Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
Outros nomes:
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Experimental: 3
Transvaginal NOTES cholecystectomy (Phase 2)
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Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Safety and Efficacy of Transvaginal NOTES cholecystectomy when compared to Laparoscopic cholecystectomy
Prazo: 12 months
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12 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Short term outcomes of Transvaginal NOTES cholecystectomy when compared to Laparoscopic Cholecystectomy
Prazo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Homero Rivas, MD, Hospital de La Paz
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 05626
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