Psychology of Minimally Invasive Surgical Scars

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT03004560
Collaborator
Teleflex (Industry)
32
1
2
35.9
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard Laparoscopic Approach
  • Procedure: Percutaneous Approach
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Psychology of Minimally Invasive Surgical Scars
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. Change in Psychometric testing questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Body Mass Index 35 to 45

  • Undergoing Bariatric Surgery

Exclusion Criteria:
  • Body Mass Index <35 or >45

  • Previous Bariatric Surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Center for Metabolic and Weight Loss Surgery Durham North Carolina United States 27704

Sponsors and Collaborators

  • Duke University
  • Teleflex

Investigators

  • Principal Investigator: Dana Portenier, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03004560
Other Study ID Numbers:
  • Pro00075024
First Posted:
Dec 29, 2016
Last Update Posted:
Sep 10, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Duke University

Study Results

No Results Posted as of Sep 10, 2020