A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
Cholelithiasis
About this trial
This is an interventional treatment trial for Cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- age higher than 18 and lower than 80
- American Society of Anesthesiologists class (ASA) I-II,
- absence of any previous anesthetic complication,
- accompaniment by a responsible adult during 24 hours,
- symptomatic gallstones candidate to cholecystectomy
- and a signed informed consent.
Exclusion Criteria:
- a Body Mass Index (BMI) higher than 35,
- any laparoscopic contraindication,
- acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
- anti-inflammatory allergy
- psychiatric history that could hinder ambulatory procedure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Single Incision Cholesystectomy (SILC)
Four Ports Cholecystectomy (4PCL)
Single Incision Laparoscopic Cholecystectomy (SILC): The umbilicus is grasped and a 2 cm vertical skin and fascial incision is performed. A multiport (TriPort®) is inserted under direct vision. Principles of cholecystectomy are the same as traditional laparoscopic cholecystectomy.
Four Ports Conventional laparoscopic cholecystectomy (4PCL): A 10mm supraumbilical incision is made and the pneumoperitoneum insufflated through a Veress needle. 4 ports are introduced: 2 of 10mm in supraumbilical and left flank and 2 of 5mm in epigastric and right flank.