5-511: Cholecystectomy K81.1 K80.2
Conditions
Interventions
Group 1: Group A (conventional cholecystectomy): Beside the 10mm optic trocar in the bellybutton, 3 further trocars are inserted, two 5 mm trocars in the right upper abdomen, and one 10 mm trocar in t
Sponsors
Klinik für Viszeral-, Thorax- und Gefäßchirurgie
Kreiskrankenhaus Gummersbach
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Symptomatic cholecystolithiasis; Indication for elective cholecystectomy; Age >=18 years and legal competence
Exclusion criteria
Exclusion criteria: Age > 80 year; Obesity with a Body Mass Index (BMI) > 30 kg/m2; Acute cholecystitis or locally complicated disease (gallbladder empyema, pancreatitis, etc.); Severe comorbidity, defined as American Society for Anesthesiologists (ASA) class IV oder V; Neuromuscular disease interfering with treatment or pain measurements; Chronic abuse of analagesics or alcohol; History of major abdominal surgery with a high risk of intraperitoneal adhesions (Minor operations such as appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. represent no exclusion criterion); Gravidity or breastfeeding; Allergy against analgetics; Patient's dependency to trial sponsor or physicians; Institutionalisation due to legal reasons; Participation in other clinical studies, which might interfere with the present trial; No written informed consent signed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of pain during movement as measured on postoperative days 1 to 3 (in total 6 assessments) using VAS (visual analogue scale, 0 to 10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of perioperative complications || Duration of surgery (in minutes) || Subjective cosmetic result (1 to 5 scale) || Quality of life 10 days after surgery (Gastrointestinaler Quality of Life Index (GIQLI) by Eypasch et al.) | — |
Countries
Germany
Contacts
Public ContactVerena Strassel
Klinik für Viszeral-, Thorax- und Gefäßchirurgie Kreiskrankenhaus Gummersbach
Outcome results
None listed