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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by The Oregon Clinic
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Lee Swanstrom, The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01174069
First received: July 30, 2010
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Cholecystitis
Procedure: NOTES assisted laparoscopic cholecystectomy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 30 days post operatively ] [ Designated as safety issue: No ]
    standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient.


Estimated Enrollment: 25
Study Start Date: May 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOTES cholecystectomy Procedure: NOTES assisted laparoscopic cholecystectomy
Surgical removal of the gallbladder using endoscopic instruments.
Other Name: NOTES Cholecystectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lee Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01174069     History of Changes
Other Study ID Numbers: LHS0701
Study First Received: July 30, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Oregon Clinic:
NOTES
cholecystectomy
endoscopic

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

ClinicalTrials.gov processed this record on August 21, 2014