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Psychology of Minimally Invasive Surgical Scars

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Duke University

Status

Terminated

Conditions

Obesity

Treatments

Procedure: Standard Laparoscopic Approach
Procedure: Percutaneous Approach

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03004560
Pro00075024

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body Mass Index 35 to 45
  • Undergoing Bariatric Surgery

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Standard Laparoscopic Approach
Active Comparator group
Description:
Minimally invasive laparoscopic procedure with 5-10 mm incisions.
Treatment:
Procedure: Standard Laparoscopic Approach
Percutaneous Approach
Active Comparator group
Description:
Minimally invasive laparoscopic procedure with 2-3 mm incisions.
Treatment:
Procedure: Percutaneous Approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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