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| Name | Class |
|---|---|
| Teleflex | INDUSTRY |
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The purpose of this study is to examine the psychological and psychosocial impact of surgical scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo bariatric procedures through the Duke Metabolic & Weight Loss Surgery program will be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic surgery and 50 will be assigned to the percutaneous group. All patients will complete pre-operative psychometric testing to establish a baseline body-image score as well as a patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after surgery. Subjects will complete the same psychometric measures to identify differences in psychological and psychosocial responses to standard laparoscopic and percutaneous scars. Patients will also complete a measure on scar satisfaction. The investigators hope to identify any differences between standard laparoscopic versus percutaneous approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Laparoscopic Approach | Active Comparator | Minimally invasive laparoscopic procedure with 5-10 mm incisions. |
|
| Percutaneous Approach | Active Comparator | Minimally invasive laparoscopic procedure with 2-3 mm incisions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Laparoscopic Approach | Procedure | Minimally invasive laparoscopic surgery with 5-10 mm incisions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Scar satisfaction | Patients will complete a scar assessment at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year. | Baseline, 3 weeks, 3 months, 6 months and 1 year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Abdominal pain scale | Patients will complete an abdominal pain scale (0-10) at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year. | Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psychometric testing questionnaire | Psychometric testing will be performed to obtain a body image score and to see how/if that changes over time. | Baseline, 3 weeks, 3 months, 6 months and 1 year post-op |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Portenier, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Metabolic and Weight Loss Surgery | Durham | North Carolina | 27704 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Percutaneous Approach | Procedure | Minimally invasive laparoscopic surgery with 2-3 mm incisions. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |