Psychology of Minimally Invasive Surgical Scars

September 8, 2020 updated by: Duke University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke Center for Metabolic and Weight Loss Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index 35 to 45
  • Undergoing Bariatric Surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Scar satisfaction
Time Frame: 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.
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
Time Frame: 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.
Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Psychometric testing questionnaire
Time Frame: Baseline, 3 weeks, 3 months, 6 months and 1 year post-op
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Teleflex

Investigators

  • Principal Investigator: Dana Portenier, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00075024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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