Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

• Operative complications [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
• length of hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• doses of analgesics [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• hospital/operation charges [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• surgeon perception of difficulty [ Time Frame: 1 day ] [ Designated as safety issue: No ]
• cosmetic scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

• Cholelithiasis
• Biliary Dyskinesia

• Procedure: SILS
  Single Incision Laparoscopic Cholecystectomy
  Other Name: SILS
• Procedure: Standard Laparoscopic Cholecystectomy
  4 port technique
  Other Name: Laparoscopic Cholecystectomy

• Active Comparator: SILS Cholecystectomy
  Single Incision Laparoscopic Cholecystectomy
  Intervention: Procedure: SILS
• Active Comparator: Standard Laparoscopic Cholecystectomy
  4 port laparoscopic cholecystectomy
  Intervention: Procedure: Standard Laparoscopic Cholecystectomy

Inclusion Criteria:

• Need for cholecystectomy

Exclusion Criteria:

• Need for cholangiogram