5-511.11: Laparoscopic cholecystectomy K80.20 K80.10
Conditions
Interventions
Group 1: Needlescopic cholecystectomy with 3 trocars: we will use two 2-3 mm working trocars and one 10 mm optic trocar, its access is also used for extraction of the gallbladder.
Group 2: Transvagina
Sponsors
Klinik für Viszeral-, Gefäß- und Transplantationschirurgie
Lehrstuhl Chirurgie I
Universitätsklinikum Witten/Herdecke mit Sitz in Köln
Krankenhaus Merheim
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Female gender; indication for elective cholecystectomy on account of symptomatic cholecystolithiasis; age >=18 years and <=80 years; legal competence.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of pain in motion measured from operation day to postoperative day 2. This outcome includes a total of 4 measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cosmetic aspects and overall satisfaction with the results of the surgery: 1 (complete satisfaction) to 5 (complete dissatisfaction) scale. || Intraoperative complications, undesirable events, conversions. || Duration of the operation (in minutes). || Surgical handling for the first and second surgeon on a 1 to 5 scale. || Intensity of pain in motion measured from postoperative day 2 to 10. This outcome includes a total of 17 measurements. || Use of analgesics: quantity, dose and class of the used drugs between the operative day and postoperative day 10. || Postoperative complications including frequency of reoperation. || Return to everyday, work related and free time activities: duration of limitations. || Quality of life measured on postoperative day 10 with the Gastrointestinal Quality of Life Index (GIQLI) from Eypasch et al. || Postoperative restrictions of sexual function: to be measured 3 months after surgery with part of the "female sexual function index" (FSFI-D). || Morphological consequences of transvaginal access: all patients from the transvaginal/transumbilical group will be examined by a gynaecologist before their operation, and again 10 to 14 days and 6 months after their surgery. | — |
Countries
Germany
Contacts
Public ContactDirk R. Bulian
Klinik für Viszeral-, Gefäß- und Transplantationschirurgie Lehrstuhl Chirurgie I Universitätsklinikum Witten/Herdecke mit Sitz in Köln Krankenhaus Merheim
Outcome results
None listed