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NOTES-Assisted Laparoscopic Cholecystectomy Surgery

NCT ID: NCT00486655

Last Updated: 2012-08-08

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

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-06-30

Brief Summary

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This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Detailed Description

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A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Conditions

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Cholelithiasis Cholecystitis

Keywords

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Cholecystectomy NOTES Transgastric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NOTES-Assisted Cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Ability to undergo general anesthesia
* Age \>= 18 yrs. of age and \<= 85 yrs. of age
* Ability to give informed consent

Exclusion Criteria

* Acute cholecystitis
* BMI \>= 40
* Contraindicated for EGD
* Presence of common duct stones
* Presence of esophageal stricture
* Altered gastric anatomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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USGI Medical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Lee Swanstrom, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Clinic

Locations

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Oregon Clinic

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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LS0701

Identifier Type: -

Identifier Source: org_study_id