Cholecystitis Clinical Trial
— NOTEScholeOfficial title:
Clinical Outcomes Trial of Laparoscopic Assisted Transgastric Endoscopic Cholecystectomy
NCT number | NCT01174069 |
Other study ID # | LHS0701 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2007 |
Est. completion date | October 2015 |
Verified date | August 2019 |
Source | The Oregon Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Legacy health System | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
The Oregon Clinic | Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pain | perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record. | 30 days | |
Secondary | Perception of surgical outcome | standardized Quality of Life (QOL) assessment (i.e., SF-36) form filled out by the patient. | 30 days post operatively |
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