Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

Saint Luke's Health System

Status: Terminated

Conditions: Cholecystitis; Gallstones; Cholelithiasis; Biliary Dyskinesia

Treatments: Procedure: Single-Incision Laparoscopic Surgery cholecystectomy; Procedure: Traditional Laparoscopic Cholecystectomy (TLC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01195285

09-423

Details and patient eligibility

About

This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

Full description

Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Enrollment: 87 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient recommended to undergo cholecystectomy
• Patient age 18-80
• Patient competent to give his/her own informed consent
• Patient speaks English without the need for an interpreter

Exclusion criteria

• Additional procedures planned during same surgery
• Patient deemed inappropriate for TLC or SILS cholecystectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups

Single-Incision Laparoscopic Cholecsytectomy (SILS)

Active Comparator group

Treatment:

Procedure: Single-Incision Laparoscopic Surgery cholecystectomy

Traditional Laparoscopic Cholecystectomy (TLC)

Active Comparator group

Treatment:

Procedure: Traditional Laparoscopic Cholecystectomy (TLC)