Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

Launched by UNIVERSITY OF WITTEN/HERDECKE · Sep 11, 2012

Keywords

ClinConnect Summary

The amount of trauma inflicted, especially in abdominal operations, depends largely on target organ access. Great efforts have been made to minimize access trauma. The further development of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal technique. The aim of this randomized study is to compare these two techniques in female patients that are in need of an elective cholecyste...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Gender: Female
• • Minimum Age: 18 Years
• • Maximum Age: 80 Years
• • 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, choledocholithiasis, 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 analgesics 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