ObesityNCT03004560
Psychology of Minimally Invasive Surgical Scars
A study testing Standard Laparoscopic Approach and Percutaneous Approach in people with Obesity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Laparoscopic Approach and Percutaneous Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index 35 to 45
- Undergoing Bariatric Surgery
Who cannot join
- Body Mass Index <35 or >45
- Previous Bariatric Surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, 27704
About this study
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
- Being tested
- Standard Laparoscopic Approach, Percutaneous Approach
- Keywords
- Bariatric, standard laparoscopic surgery, minimally invasive, scars, psychology
- Medical subject headings
- Obesity, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Laparoscopic ApproachProcedure or surgery
Minimally invasive laparoscopic surgery with 5-10 mm incisions.
Percutaneous ApproachProcedure or surgery
Minimally invasive laparoscopic surgery with 2-3 mm incisions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Laparoscopic Approach | Active comparator | Minimally invasive laparoscopic procedure with 5-10 mm incisions. Receives: Procedure: Standard Laparoscopic Approach |
| Percutaneous Approach | Active comparator | Minimally invasive laparoscopic procedure with 2-3 mm incisions. Receives: Procedure: Percutaneous Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 weeks, 3 months, 6 months and 1 year post-op
Secondary outcomes (1)
Change in the Abdominal pain scale
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.
Measured: Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex
- Responsible party
- Sponsor
- Investigators
- Dana Portenier, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004560
- Sponsor's protocol ID
- Pro00075024
- Status last verified
- Sep 2020
- First submitted
- 20 Dec 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychology of Minimally Invasive Surgical Scars
- ClinicalTrials.gov ID
- NCT03004560
- Acronym / sponsor ID
- Pro00075024
- Conditions
- Obesity
- Keywords
- Bariatric, standard laparoscopic surgery, minimally invasive, scars, psychology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Teleflex
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Laparoscopic Approach | Active comparator | Procedure: Standard Laparoscopic ApproachMinimally invasive laparoscopic procedure with 5-10 mm incisions. |
| Percutaneous Approach | Active comparator | Procedure: Percutaneous ApproachMinimally invasive laparoscopic procedure with 2-3 mm incisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index 35 to 45
- Undergoing Bariatric Surgery
Key exclusion criteria (2 listed)
- Body Mass Index <35 or >45
- Previous Bariatric Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Laparoscopic ApproachMinimally invasive laparoscopic surgery with 5-10 mm incisions. | Procedure or surgery | Standard Laparoscopic Approach |
| Percutaneous ApproachMinimally invasive laparoscopic surgery with 2-3 mm incisions. | Procedure or surgery | Percutaneous Approach |
Primary outcome
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.
1 secondary outcome
Change in the Abdominal pain scale
Time frame: Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Portenier, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Laparoscopic Approach and Percutaneous Approach in people with Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scar satisfaction (time frame: Baseline, 3 weeks, 3 months, 6 months and 1 year post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.