Body ContouringNCT05771259
Body Contouring After Bariatric Surgeries in Jordan
An observational study of Body Contouring, run by University of Jordan at 1 site in Jordan.
Trial summary
This study aimed to describe Jordanians' awareness and knowledge of body-contouring surgeries and estimate their prevalence. Additionally, we aimed to identify the limitations reported by our population and compare them with those reported in the literature. Read more about this study
- Who is it for?
- Ages 13 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Contouring
- What is being tested?
- Assessment of knowledge and behaviour
- How many people
- 294 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jul 2017to 20 Feb 2023
- Phase
- Observational
- 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 13 to 63 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Of the 451 patients, 305 completed the questionnaire (response rate: 67.6%). The inclusion criteria were age 13-63 years, BS type (sleeve gastrectomy or Roux-en-Y bypass), and completion of the questionnaire.
Who may be able to join
- Age 13-63 years
- Bariatric surgery type (LSG or RYGB)
Who cannot join
- Incomplete or duplicate reponses
- Bariatric surgery ype (Gastric band)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ody Contouring After Bariatric Surgeries in Jordan: Awareness, Prevalence, and Challenges
This study aimed to describe Jordanians' awareness and knowledge of body-contouring surgeries and estimate their prevalence. Additionally, we aimed to identify the limitations reported by our population and compare them with those reported in the literature.
Read the detailed description
We aimed to reach out to 351 patients who underwent bariatric surgery at JUH as well as an additional 100 patients who underwent BS at one of the largest private medical facilities in Amman between January and June of 2021. We distributed a validated questionnaire to all patients. Of the 451 patients, 305 completed the questionnaire (response rate: 67.6%). The inclusion criteria were age 13-63 years, BS type (sleeve gastrectomy or Roux-en-Y bypass), and completion of the questionnaire. Responses that did not meet these criteria or contained duplicates were excluded (n=11). The remaining 294 responses were collected and entered into a database for the analysis.Three main variables were assessed in each group in addition to multiple other observations. The main variables were sex, marital status, and employment status.
- Conditions
- Body Contouring
- Being tested
- Assessment of knowledge and behaviour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of knowledge and behaviourOther
Assessment of knowledge and behaviour
| Study group | Role | What they receive |
|---|---|---|
| Group A | Participants who didn't undergo body contouring surgery after bariatric surgery. Receives: Other: Assessment of knowledge and behaviour | |
| Group B | Participants who underwent body contouring surgery after bariatric surgery. Receives: Other: Assessment of knowledge and behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Body contouring surgeries after bariatric surgeries
Measured: 07/2017-06/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jul 2017
- Primary completion30 Jun 2021
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body ContouringStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Atallah, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771259
- Sponsor's protocol ID
- 10/2023/5723
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nguyen NT, Root J, Zainabadi K, Sabio A, Chalifoux S, Stevens CM, Mavandadi S, Longoria M, Wilson SE. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg. 2005 Dec;140(12):1198-202; discussion 1203. doi: 10.1001/archsurg.140.12.1198.
PubMed 16365242Ellison JM, Steffen KJ, Sarwer DB. Body Contouring After Bariatric Surgery. Eur Eat Disord Rev. 2015 Nov;23(6):479-87. doi: 10.1002/erv.2408. Epub 2015 Sep 22.
PubMed 26395601Monpellier VM, Antoniou EE, Mulkens S, Janssen IMC, Jansen ATM, Mink van der Molen AB. Body Contouring Surgery after Massive Weight Loss: Excess Skin, Body Satisfaction, and Qualification for Reimbursement in a Dutch Post-Bariatric Surgery Population. Plast Reconstr Surg. 2019 May;143(5):1353-1360. doi: 10.1097/PRS.0000000000005525.
PubMed 30789477Derderian SC, Patten L, Kaizer AM, Inge TH, Jenkins TM, Michalsky MP, Xie C, Dewberry LC, Sitzman TJ. Body contouring in adolescents after bariatric surgery. Surg Obes Relat Dis. 2020 Jan;16(1):137-142. doi: 10.1016/j.soard.2019.09.063. Epub 2019 Sep 18.
PubMed 31668945Aldaqal SM, Samargandi OA, El-Deek BS, Awan BA, Ashy AA, Kensarah AA. Prevalence and desire for body contouring surgery in postbariatric patients in saudi arabia. N Am J Med Sci. 2012 Feb;4(2):94-8. doi: 10.4103/1947-2714.93386.
PubMed 22408756Hult M, Bonn SE, Brandt L, Wiren M, Lagerros YT. Women's Satisfaction with and Reasons to Seek Bariatric Surgery-a Prospective Study in Sweden with 1-Year Follow-up. Obes Surg. 2019 Jul;29(7):2059-2070. doi: 10.1007/s11695-019-03834-3.
PubMed 30955156
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ody Contouring After Bariatric Surgeries in Jordan: Awareness, Prevalence, and Challenges
- ClinicalTrials.gov ID
- NCT05771259
- Acronym / sponsor ID
- 10/2023/5723
- Conditions
- Body Contouring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- 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.
This study aimed to describe Jordanians' awareness and knowledge of body-contouring surgeries and estimate their prevalence. Additionally, we aimed to identify the limitations reported by our population and compare them with those reported in the literature.
Detailed description
We aimed to reach out to 351 patients who underwent bariatric surgery at JUH as well as an additional 100 patients who underwent BS at one of the largest private medical facilities in Amman between January and June of 2021. We distributed a validated questionnaire to all patients. Of the 451 patients, 305 completed the questionnaire (response rate: 67.6%). The inclusion criteria were age 13-63 years, BS type (sleeve gastrectomy or Roux-en-Y bypass), and completion of the questionnaire. Responses that did not meet these criteria or contained duplicates were excluded (n=11). The remaining 294 responses were collected and entered into a database for the analysis.Three main variables were assessed in each group in addition to multiple other observations. The main variables were sex, marital status, and employment status.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Assessment of knowledge and behaviourParticipants who didn't undergo body contouring surgery after bariatric surgery. |
| Group B | – | Other: Assessment of knowledge and behaviourParticipants who underwent body contouring surgery after bariatric surgery. |
Who may qualify
- Ages
- 13 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Of the 451 patients, 305 completed the questionnaire (response rate: 67.6%). The inclusion criteria were age 13-63 years, BS type (sleeve gastrectomy or Roux-en-Y bypass), and completion of the questionnaire.
Key inclusion criteria (2 listed)
- Age 13-63 years
- Bariatric surgery type (LSG or RYGB)
Key exclusion criteria (2 listed)
- Incomplete or duplicate reponses
- Bariatric surgery ype (Gastric band)
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 |
|---|---|---|
| Assessment of knowledge and behaviourAssessment of knowledge and behaviour | Other | Group A, Group B |
Primary outcome
Prevalence of Body contouring surgeries after bariatric surgeries
Time frame: 07/2017-06/2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 16365242Nguyen NT, Root J, Zainabadi K, Sabio A, Chalifoux S, Stevens CM, Mavandadi S, Longoria M, Wilson SE. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg. 2005 Dec;140(12):1198-202; discussion 1203. doi: 10.1001/archsurg.140.12.1198.
- Background: PubMed 26395601Ellison JM, Steffen KJ, Sarwer DB. Body Contouring After Bariatric Surgery. Eur Eat Disord Rev. 2015 Nov;23(6):479-87. doi: 10.1002/erv.2408. Epub 2015 Sep 22.
- Background: PubMed 30789477Monpellier VM, Antoniou EE, Mulkens S, Janssen IMC, Jansen ATM, Mink van der Molen AB. Body Contouring Surgery after Massive Weight Loss: Excess Skin, Body Satisfaction, and Qualification for Reimbursement in a Dutch Post-Bariatric Surgery Population. Plast Reconstr Surg. 2019 May;143(5):1353-1360. doi: 10.1097/PRS.0000000000005525.
- Background: PubMed 31668945Derderian SC, Patten L, Kaizer AM, Inge TH, Jenkins TM, Michalsky MP, Xie C, Dewberry LC, Sitzman TJ. Body contouring in adolescents after bariatric surgery. Surg Obes Relat Dis. 2020 Jan;16(1):137-142. doi: 10.1016/j.soard.2019.09.063. Epub 2019 Sep 18.
- Background: PubMed 22408756Aldaqal SM, Samargandi OA, El-Deek BS, Awan BA, Ashy AA, Kensarah AA. Prevalence and desire for body contouring surgery in postbariatric patients in saudi arabia. N Am J Med Sci. 2012 Feb;4(2):94-8. doi: 10.4103/1947-2714.93386.
- Background: PubMed 30955156Hult M, Bonn SE, Brandt L, Wiren M, Lagerros YT. Women's Satisfaction with and Reasons to Seek Bariatric Surgery-a Prospective Study in Sweden with 1-Year Follow-up. Obes Surg. 2019 Jul;29(7):2059-2070. doi: 10.1007/s11695-019-03834-3.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Contouring, run by University of Jordan at 1 site in Jordan.
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: finished, as of the sponsor's last update on 16 Mar 2023. 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 Jordan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Body contouring surgeries after bariatric surgeries (time frame: 07/2017-06/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771259, which also lists 6 linked publications.
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 16 Mar 2023.