Psychology of Minimally Invasive Surgical Scars

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Procedure: Standard Laparoscopic Approach; Procedure: Percutaneous Approach

• Registration Number: NCT03004560
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2017-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Body Mass Index 35 to 45
• Undergoing Bariatric Surgery

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Exclusion Criteria

• Body Mass Index <35 or >45
• Previous Bariatric Surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Laparoscopic Approach	Standard Laparoscopic Approach	Minimally invasive laparoscopic procedure with 5-10 mm incisions.
Percutaneous Approach	Percutaneous Approach	Minimally invasive laparoscopic procedure with 2-3 mm incisions.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke Center for Metabolic and Weight Loss Surgery; 🇺🇸 Durham, North Carolina, United States