Conventional laparoscopic versus needleskopic versus single-port cholecystectomy - a randomised clinical trial

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2020
INTERVENTION: Intervention 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 the left abdomen. Intervention 2: Group B (needlescopic cholecystectomy): The three working trocars all have a diameter of only 3 mm. Intervention 3: Gruppe C (SILS): The Single Port System (SILS(R) by Covidien) is placed in the bellybutton. CONDITION: K80.2 ‐ Calculus of gallbladder without cholecystitis K81.1 ‐ Chronic cholecystitis PRIMARY OUTCOME: 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 OUTCOME: 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.) INCLUSION CRITERIA: Symptomatic cholecystolithiasis; Indication for elective cholecystectomy; Age >=18 years and legal competence
Epistemonikos ID: 2a0c860f80bf2a6366484ba317692c93e8d2a57d
First added on: Dec 17, 2020