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临床试验/DRKS00000341
DRKS00000341已完成未知

eedlescopic versus transvaginal/transumbilical cholecystectomy: a randomized clinical trial - NATCH

Klinik für Viszeral-, Gefäß- und TransplantationschirurgieLehrstuhl Chirurgie IUniversitätsklinikum Witten/Herdecke mit Sitz in KölnKrankenhaus Merheim0 个研究点目标入组 40 人开始时间: 2010年2月24日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
Female

入选标准

  • Female gender; indication for elective cholecystectomy on account of symptomatic cholecystolithiasis; age >=18 years and <=80 years; legal competence.

排除标准

  • Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithisis, pancreatitis, etc.); liver cirrhosis (Child Pugh A, B, C); severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA); intact hymen; acute vaginal infection; lacking visibility of the uterine orifice; endometriosis; malignoma; obesity with a Body Mass Index (BMI) > 40 kg/m2; chronic abuse of analagesics or alcohol; neuromuscular disease that could interfere treatment or measures of pain; history of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria); gravidity or breastfeeding; allergy against analgesics; patients who are dependent on or employed by the trial sponsor or physicians; institutionalisation for legal reasons; participation in other clinical studies that could interfere with the present trial; no written informed consent signed.

研究者

发起方
Klinik für Viszeral-, Gefäß- und TransplantationschirurgieLehrstuhl Chirurgie IUniversitätsklinikum Witten/Herdecke mit Sitz in KölnKrankenhaus Merheim

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