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 sites40 target enrollmentFebruary 24, 2010

Conditions5-511.11: Laparoscopic cholecystectomy K80.20 K80.10

Overview

Phase: 未知
Intervention: Not specified
Conditions: 5-511.11: Laparoscopic cholecystectomy
Sponsor: Klinik für Viszeral-, Gefäß- und TransplantationschirurgieLehrstuhl Chirurgie IUniversitätsklinikum Witten/Herdecke mit Sitz in KölnKrankenhaus Merheim
Enrollment: 40
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 24, 2010

End Date

January 4, 2013

Last Updated

last year

Study Type

Interventional

Sex

Female

Investigators

Sponsor

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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.