Psychology of Minimally Invasive Surgical Scars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Duke University
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change in Scar satisfaction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in Scar satisfaction
Time Frame: 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 Outcomes
- Change in the Abdominal pain scale(Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op)