Psychology of Minimally Invasive Surgical Scars

Sponsor

Duke University (Other)

Overall Status

Terminated

CT.gov ID

NCT03004560

Collaborator

Teleflex (Industry)

Enrollment

Location

Arms

35.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

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
Obesity	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.

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

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

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

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:

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:

Plan to Share IPD:

Keywords provided by Duke University

Bariatric

standard laparoscopic surgery

minimally invasive

scars

psychology

Study Results

No Results Posted as of Sep 10, 2020