Multi-Port Versus Single-port Cholecystectomy (MUSIC)
Cholelithiasis
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring SINGLE PORT SURGERY, LAPAROSCOPY, CHOLECYSTECTOMY
Eligibility Criteria
Inclusion Criteria:
- age: 18-75
- BMI: <30
- ASA: I-III
- absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
- diagnosis: cholelithiasis (gallstones < 2 cm in diameter) gallbladder dyskinesia
Exclusion Criteria:
- cholecystitis
- suspected presence of common duct stones
- suspected presence of biliary cancer
- Previous abdominal surgery
- Previous umbilical surgery
Sites / Locations
- University of Turin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Multi port
Single port
4-Ports Cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbelical Hasson's port or by a Verress needle followed by a 10 mm umbelical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique. A straight or angulated laparoscope may be used. Laparoscopic graspers, monopolar hook, bipolar forceps, scissors and 10mm clips-applier are used. A plastic bag system might be used for gall bladder extraction if necessary. In both 10 and 12mm accesses, fascia is sutured with resorbable sutures. Skin is secured by either metallic agraffes or interrupted sutures.
Single-Port Cholecystectomy (SPC): a 2.5cm long skin incision around the umbilicus is performed. The subcutaneous tissue is dissected, the muscular fascia exposed and incised along the middle line (linea alba) respecting the muscular tissue. Peritoneum is identified and incised. The Single-Port device is inserted and anchored. In order to retract the gallbladder a transcutaneous suture is placed in the right hypocondrium with a straight needle and a monofilament thread which are passed through the fundus and knotted outside the skin. The following steps reproduce the traditional laparoscopic cholecystectomy. Each centre will be left free to use dedicated instruments and which or traditional laparoscopic ones.