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Psychology of Minimally Invasive Surgical Scars

NCT03004560 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-09-10

No results posted yet for this study

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

Interventions

PROCEDURE

Standard Laparoscopic Approach

Minimally invasive laparoscopic surgery with 5-10 mm incisions.

PROCEDURE

Percutaneous Approach

Minimally invasive laparoscopic surgery with 2-3 mm incisions.

Sponsors & Collaborators

Principal Investigators

  • Dana Portenier, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004560 on ClinicalTrials.gov