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| Name | Class |
|---|---|
| Ethicon Endo-Surgery | INDUSTRY |
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Background Laparoscopy is the preferred surgical approach for a number of different diseases as it allows for diagnosis and treatment in the setting of a safe and feasible method offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which utilizes smaller instruments and optics. Technological advancements have enabled miniaturization of the surgical equipment without compromising diagnostic or operative capabilities.
Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size to decrease trauma to the abdominal wall.
Study Design Both methods have never been compared in a prospective randomized trial to address the following questions.
Patient Population Projected sample size would be 50 patients in each group. Accrual should be feasible over the course of 9-12 months.
Data collection (patients will be followed for a total of 30 days for the purpose of this study)
This study compares two groups of patients who have voluntarily chosen to undergo roux-n-y gastric bypass surgery. The groups will be randomized to receive micro-laparoscopic or laparoscopic surgery to be performed by the same surgeon, Dr. Keith Zuccala.
Study Schema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-laparoscopic bypass | Active Comparator |
| |
| Laparoscopic gastric bypass | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microlaparoscopic gastric bypass | Procedure | microlaparoscopic gastric bypass will be performed using standard of care procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of micro-laparoscopic versus laparoscopic gastric bypass | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | 30 days | |
| Time off from work | 30 days | |
| Operating Cost |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Saldinger, M.D. | Danbury Hospital | Study Chair |
| Keith Saldinger, M.D. | Danbury Hospital | Principal Investigator |
| Suzanne J House, M.S., Ph.D. | Danbury Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danbury Hospital | Danbury | Connecticut | 06810 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Laparoscopic Surgery | Procedure | laparoscopic gastric bypass will be performed using standard of care procedure. |
|
| The time of surgery is collected following patient discharge approximately 4 to 5 days |
| Time of Surgery | The time of surgery is collected following patient discharge approximately 4 to 5 days. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |