Cholecystolithiasis Digestive System Cholelithiasis
Conditions
Interventions
1. Transvaginal cholecystectomy
2. Laparoscopic cholecystectomy
Sponsors
Sana Hospital Lichtenberg (Sana Klinikum Lichtenberg) (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Full age (18 years or older) 3. Symptomatic cholecystolithiasis
Exclusion criteria
Exclusion criteria: 1. Male 2. <18 years 3. Patients desire for transvaginal/laparoscopic operation 4. Multiple adhesions 5. emergency 6. Acute cholecystitis 7. Choledocholithiasis 8. Malignoma 9. Acute vaginal infection 10. Gynaecological disease 11. Gravidity 12. Endometriosis 13. American Society of Anesthesiologists (ASA) IV 14. Liver disease (Child Pugh Criteria A, B, C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain, assessed with a numeric rating scale. All outcomes will be assessed on the 7th and 28th postoperative day and 1 year after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wound infections 2. Trokar herniation 3. Morbidity 4. Mortality 5. Complications 6. Fatigue 7. Costs 8. Quality of life, assessed by a tool developed by Eypasch et al (1995) and SF-36 Health Survey 9. Long-term outcome All outcomes will be assessed on the 7th and 28th postoperative day and 1 year after surgery. | — |
Countries
Germany
Outcome results
None listed