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Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder (NOTESchole)

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ClinicalTrials.gov Identifier: NCT01174069
Recruitment Status : Unknown
Verified October 2012 by Lee Swanstrom, The Oregon Clinic.
Recruitment status was:  Recruiting
First Posted : August 3, 2010
Last Update Posted : October 4, 2012
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Lee Swanstrom, The Oregon Clinic

Brief Summary:
Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring.

Condition or disease Intervention/treatment Phase
Cholecystitis Procedure: NOTES assisted laparoscopic cholecystectomy Phase 1 Phase 2

Detailed Description:

In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. Once dissected free, the gall bladder will be removed through the stomach and out of the mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed.

Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. During the hospital stay severity of pain and use of pain medications will be recorded. Length of time spent in the recovery room and in the hospital will also be collected. Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
Study Start Date : May 2007
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NOTES cholecystectomy Procedure: NOTES assisted laparoscopic cholecystectomy
Surgical removal of the gallbladder using endoscopic instruments.
Other Name: NOTES Cholecystectomy



Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 30 days ]
    perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 30 days post operatively ]
    standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to undergo general anesthesia
  2. Age > 18 years of age and < 80 years of age
  3. Ability to give informed consent

Exclusion Criteria:

  1. Acute cholecystitis
  2. Body Mass Index (BMI) > 40
  3. Contraindicated for esophagogastroduodenoscopy (EGD)
  4. Gallstones > 2.5cm in diameter
  5. Gall bladder more than 15cm in length on U/S
  6. Presence of common duct stones
  7. Presence of esophageal stricture
  8. Altered gastric anatomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174069


Contacts
Contact: Lee L Swanstrom, MD 503-281-0561 lswanstrom@orclinic.com

Locations
United States, Oregon
Legacy health System Recruiting
Portland, Oregon, United States, 97210
Principal Investigator: Lee L Swanstrom, MD         
Sponsors and Collaborators
The Oregon Clinic
Northwestern University
Investigators
Principal Investigator: Lee L Swanstrom, MD Legacy Health System
Study Director: Angi B Gill, RN Oregon Clinic

Responsible Party: Lee Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01174069     History of Changes
Other Study ID Numbers: LHS0701
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Lee Swanstrom, The Oregon Clinic:
NOTES
cholecystectomy
endoscopic

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases