Psychology of Minimally Invasive Surgical Scars

NCT03004560 | Terminated

• 1 other identifier: Pro00075024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Bariatric; standard laparoscopic surgery; minimally invasive; scars; psychology

Outcome Measures

Primary Outcomes (1)

• Change in Scar satisfaction

  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 Outcomes (1)

• Change in the Abdominal pain scale

  Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op

Other Outcomes (1)

• Change in Psychometric testing questionnaire

  Baseline, 3 weeks, 3 months, 6 months and 1 year post-op

Study Arms (2)

Standard Laparoscopic Approach

ACTIVE COMPARATOR

Minimally invasive laparoscopic procedure with 5-10 mm incisions.

Procedure: Standard Laparoscopic Approach

Percutaneous Approach

ACTIVE COMPARATOR

Minimally invasive laparoscopic procedure with 2-3 mm incisions.

Procedure: Percutaneous Approach

Interventions

Standard Laparoscopic Approach PROCEDURE

Minimally invasive laparoscopic surgery with 5-10 mm incisions.

Standard Laparoscopic Approach

Percutaneous Approach PROCEDURE

Minimally invasive laparoscopic surgery with 2-3 mm incisions.

Percutaneous Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index 35 to 45
• Undergoing Bariatric Surgery

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Teleflex: collaborator

Study Sites (1)

Duke Center for Metabolic and Weight Loss Surgery

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Obesity; Cicatrix

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Study Officials

• Dana Portenier, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)