eedlescopic versus transvaginal/transumbilical cholecystectomy: a randomized clinical trial
- Conditions
- K80.20K80.105-511.11: Laparoscopic cholecystectomy
- Registration Number
- DRKS00000341
- Lead Sponsor
- Klinik für Viszeral-, Gefäß- und TransplantationschirurgieLehrstuhl Chirurgie IUniversitätsklinikum Witten/Herdecke mit Sitz in KölnKrankenhaus Merheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 40
Female gender; indication for elective cholecystectomy on account of symptomatic cholecystolithiasis; age >=18 years and <=80 years; legal competence.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intensity of pain in motion measured from operation day to postoperative day 2. This outcome includes a total of 4 measurements.
- Secondary Outcome Measures
Name Time Method