Psychology of Minimally Invasive Surgical Scars

Obesity Clinical Trial

Official title:

Psychology of Minimally Invasive Surgical Scars

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03004560
• Other study ID #: Pro00075024
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index 35 to 45

• Undergoing Bariatric Surgery

Exclusion Criteria:

• Body Mass Index <35 or >45

• Previous Bariatric Surgery

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Standard Laparoscopic Approach
Minimally invasive laparoscopic surgery with 5-10 mm incisions.
• Percutaneous Approach
Minimally invasive laparoscopic surgery with 2-3 mm incisions.

Locations

Country	Name	City	State
United States	Duke Center for Metabolic and Weight Loss Surgery	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Teleflex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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