NOTES-Assisted Laparoscopic Cholecystectomy Surgery

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Cholecystitis
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Brief Title

NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Official Title

Assisted Laparoscopic Cholecystectomy Surgery

Brief Summary

      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

      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.

Study Type

Interventional

Primary Outcome

Quality of Life

Secondary Outcome

 Incidence of complications

Condition

Cholelithiasis

Intervention

NOTES-Assisted Cholecystectomy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

25

Start Date

May 2007

Completion Date

June 2007

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Lee Swanstrom, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00486655

Organization ID

LS0701

Study Sponsor

USGI Medical

Study Sponsor

Lee Swanstrom, MD, Principal Investigator, Oregon Clinic

Verification Date

August 2012