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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholecystectomy, Laparoscopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Single port laparoscopic device

Group Type EXPERIMENTAL

Laparoscopic cholecystectomy surgery

Intervention Type DEVICE

Single port laparoscopic cholecystectomy surgery versus a standard four port device.

2

Four-port laparoscopic device

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy surgery

Intervention Type DEVICE

Single port laparoscopic cholecystectomy surgery versus a standard four port device.

Interventions

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Laparoscopic cholecystectomy surgery

Single port laparoscopic cholecystectomy surgery versus a standard four port device.

Intervention Type DEVICE

Other Intervention Names

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ACS Triport, Advanced Surgical Concepts, Ireland

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No