Brief Title
Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder
Official Title
Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
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.
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
Primary Outcome
Postoperative pain
Secondary Outcome
Perception of surgical outcome
Condition
Cholecystitis
Intervention
NOTES assisted laparoscopic cholecystectomy
Study Arms / Comparison Groups
NOTES cholecystectomy
Description:
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
October 2015
Primary Completion Date
October 2015
Eligibility 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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Christy M Dunst, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01174069
Organization ID
LHS0701
Responsible Party
Principal Investigator
Study Sponsor
The Oregon Clinic
Collaborators
Northwestern University
Study Sponsor
Christy M Dunst, MD, Principal Investigator, The Oregon Clinic
Verification Date
August 2019