Psychology of Minimally Invasive Surgical Scars
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Standard Laparoscopic Approach Minimally invasive laparoscopic procedure with 5-10 mm incisions. |
Procedure: Standard Laparoscopic Approach
Minimally invasive laparoscopic surgery with 5-10 mm incisions.
|
Active Comparator: Percutaneous Approach Minimally invasive laparoscopic procedure with 2-3 mm incisions. |
Procedure: Percutaneous Approach
Minimally invasive laparoscopic surgery with 2-3 mm incisions.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body Mass Index 35 to 45
-
Undergoing Bariatric Surgery
Exclusion Criteria:
-
Body Mass Index <35 or >45
-
Previous Bariatric Surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Duke Center for Metabolic and Weight Loss Surgery | Durham | North Carolina | United States | 27704 |
Sponsors and Collaborators
- Duke University
- Teleflex
Investigators
- Principal Investigator: Dana Portenier, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00075024