Obesity
Conditions
Keywords
Bariatric, standard laparoscopic surgery, minimally invasive, scars, psychology
Brief summary
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.
Interventions
PROCEDUREStandard Laparoscopic Approach
Minimally invasive laparoscopic surgery with 5-10 mm incisions.
PROCEDUREPercutaneous Approach
Minimally invasive laparoscopic surgery with 2-3 mm incisions.
Sponsors
Teleflex
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body Mass Index 35 to 45 * Undergoing Bariatric Surgery
Exclusion criteria
* Body Mass Index \<35 or \>45 * Previous Bariatric Surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scar satisfaction | Baseline, 3 weeks, 3 months, 6 months and 1 year post-op | Patients will complete a scar assessment at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Abdominal pain scale | Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychometric testing questionnaire | Baseline, 3 weeks, 3 months, 6 months and 1 year post-op | Psychometric testing will be performed to obtain a body image score and to see how/if that changes over time. |
Countries
United States
Outcome results
None listed