Psychology of Minimally Invasive Surgical Scars

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.

Official Title
-----------------
Psychology of Minimally Invasive Surgical Scars

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Standard Laparoscopic Approach
* Procedure: Percutaneous Approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index 35 to 45 Undergoing Bariatric Surgery Exclusion Criteria: Body Mass Index <35 or >45 Previous Bariatric Surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Laparoscopic Approach<br>Minimally invasive laparoscopic procedure with 5-10 mm incisions. | Procedure: Standard Laparoscopic Approach<br>* Minimally invasive laparoscopic surgery with 5-10 mm incisions.<br>|
| Active Comparator: Percutaneous Approach<br>Minimally invasive laparoscopic procedure with 2-3 mm incisions. | Procedure: Percutaneous Approach<br>* Minimally invasive laparoscopic surgery with 2-3 mm incisions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric, standard laparoscopic surgery, minimally invasive, scars, psychology