Psychology of Minimally Invasive Surgical Scars

NCT ID: NCT03004560

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Laparoscopic Approach

Minimally invasive laparoscopic procedure with 5-10 mm incisions.

Group Type: ACTIVE_COMPARATOR

Standard Laparoscopic Approach

Intervention Type: PROCEDURE

Minimally invasive laparoscopic surgery with 5-10 mm incisions.

Percutaneous Approach

Minimally invasive laparoscopic procedure with 2-3 mm incisions.

Group Type: ACTIVE_COMPARATOR

Percutaneous Approach

Intervention Type: PROCEDURE

Minimally invasive laparoscopic surgery with 2-3 mm incisions.

Interventions

Standard Laparoscopic Approach

Minimally invasive laparoscopic surgery with 5-10 mm incisions.

Intervention Type: PROCEDURE

Percutaneous Approach

Minimally invasive laparoscopic surgery with 2-3 mm incisions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Body Mass Index 35 to 45
• Undergoing Bariatric Surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teleflex

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Portenier, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Center for Metabolic and Weight Loss Surgery

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00075024

Identifier Type: -

Identifier Source: org_study_id