A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

Providence Health & Services

Status and phase: Completed; Phase 3

Conditions: Cholecystectomy, Laparoscopic

Treatments: Device: Laparoscopic cholecystectomy surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00892879

PHS IRB # 09-14A

Details and patient eligibility

About

This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-operative diagnosis of one of the following:

  • Pancreatic cholecystitis
  • Biliary cholic
  • Biliary dyskinesia
  • Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy
  • Gallbladder polyps
  • Other diagnosis at the discretion of the surgeon

Exclusion criteria

• Acute cholecystitis
• Gallstones > 2.5cm in length on ultrasound
• Suspected presence of common duct stones
• History of jaundice
• History of gallstone pancreatic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

Single port laparoscopic device

Treatment:

Device: Laparoscopic cholecystectomy surgery

2

Active Comparator group

Description:

Four-port laparoscopic device

Treatment:

Device: Laparoscopic cholecystectomy surgery