Obesity, MorbidNCT04844320
THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
A study testing Cobb angle measurements in people with Obesity, Morbid and Back Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many… Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Obesity, Morbid, Back Pain, Scoliosis
- What is being tested?
- Cobb angle measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Dec 2021
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over the age of 18.
- Patients with a diagnosis of morbid obesity, body mass index> 40
Who cannot join
- Patients who have undergone previous vertebral surgery due to any disease
- Patients hospitalized for more than 10 days due to postoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress.
The aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.
Read the detailed description
90 morbidly obese patients who underwent Laparoscopic Sleeve Gastrectomy were included in the study. Cobb angle measurements were made by a radiologist included in the study from the PA chest radiographs of the operated patients in the preoperative period and in the first postoperative year, and they were recorded in a previously prepared database. In addition, in the preoperative period and postoperative first year evaluations of the patients; Patient satisfaction questionnaire in terms of low back pain, back pain, neck pain, and the value in% EWL of weight given after surgery were also recorded in the database.
- Conditions
- Obesity, Morbid, Back Pain, Scoliosis
- Being tested
- Cobb angle measurements
- Keywords
- Morbid obesity, cobb angle, laparoscopic sleeve gastrectomy, scoliosis
- Medical subject headings
- Obesity, Morbid, Back Pain, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobb angle measurementsDiagnostic test
PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year
| Study group | Role | What they receive |
|---|---|---|
| > 50 %EWL | Active comparator | Postoperative weight loss in first year > 50 % EWL Receives: Diagnostic Test: Cobb angle measurements |
| 50 - 25 % EWL | Active comparator | Postoperative weight loss in first year 25 - 50 % EWL Receives: Diagnostic Test: Cobb angle measurements |
| < 25 % EWL | Active comparator | Postoperative weight loss in first year < 25 % EWL Receives: Diagnostic Test: Cobb angle measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle measurements
Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.
Measured: 2 years
Secondary outcomes (2)
% EWL measurements
% EWL measurements will be made in all patients 1 and 2 years after laparoscopic sleeve gastrectomy
Measured: 2 years
Patient satisfaction
All patients will be given a patient satisfaction questionnaire, which includes the complaints of low back pain, back pain and neck pain, and compares the postoperative and pre-operative processes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed to include 3 groups of 30 patients and a total of 90 patients. 90 patients who underwent laparoscopic sleeve gastrectomy will be divided into 3 groups according to their postoperative weight gain. The first group will include patients who have lost more than 50% EWL postoperative weight, the second group will include patients who have lost 50 to 25% EWL postoperative , and the third group will include patients who have lost less than 25% EWL postoperative. Patients in these 3 groups will be randomized on www.randomisor.org. In these 3 groups, cobb angle measurements will be made on the PA chest radiographs taken at the preoperative, postoperative 1st year and postoperative 2nd year controls. Patient satisfaction questionnaires will be conducted to compare pre- and postoperative complaints such as low back pain, back pain, and neck pain in all patients. The change in cobb angles will be determined according to the weight loss ratio (% EWL) of the patients.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844320
- Sponsor's protocol ID
- DR. ANIL ERGIN
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
- ClinicalTrials.gov ID
- NCT04844320
- Acronym / sponsor ID
- DR. ANIL ERGIN
- Conditions
- Obesity, Morbid, Back Pain, Scoliosis
- Keywords
- Morbid obesity, cobb angle, laparoscopic sleeve gastrectomy, scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 14 Apr 2021 (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.
Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress.
The aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.
Detailed description
90 morbidly obese patients who underwent Laparoscopic Sleeve Gastrectomy were included in the study. Cobb angle measurements were made by a radiologist included in the study from the PA chest radiographs of the operated patients in the preoperative period and in the first postoperative year, and they were recorded in a previously prepared database. In addition, in the preoperative period and postoperative first year evaluations of the patients; Patient satisfaction questionnaire in terms of low back pain, back pain, neck pain, and the value in% EWL of weight given after surgery were also recorded in the database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study was designed to include 3 groups of 30 patients and a total of 90 patients. 90 patients who underwent laparoscopic sleeve gastrectomy will be divided into 3 groups according to their postoperative weight gain. The first group will include patients who have lost more than 50% EWL postoperative weight, the second group will include patients who have lost 50 to 25% EWL postoperative , and the third group will include patients who have lost less than 25% EWL postoperative. Patients in these 3 groups will be randomized on www.randomisor.org. In these 3 groups, cobb angle measurements will be made on the PA chest radiographs taken at the preoperative, postoperative 1st year and postoperative 2nd year controls. Patient satisfaction questionnaires will be conducted to compare pre- and postoperative complaints such as low back pain, back pain, and neck pain in all patients. The change in cobb angles will be determined according to the weight loss ratio (% EWL) of the patients.
| Arm | Type | Receives |
|---|---|---|
| > 50 %EWL | Active comparator | Diagnostic Test: Cobb angle measurementsPostoperative weight loss in first year > 50 % EWL |
| 50 - 25 % EWL | Active comparator | Diagnostic Test: Cobb angle measurementsPostoperative weight loss in first year 25 - 50 % EWL |
| < 25 % EWL | Active comparator | Diagnostic Test: Cobb angle measurementsPostoperative weight loss in first year < 25 % EWL |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18.
- Patients with a diagnosis of morbid obesity, body mass index> 40
Key exclusion criteria (2 listed)
- Patients who have undergone previous vertebral surgery due to any disease
- Patients hospitalized for more than 10 days due to postoperative complications
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 |
|---|---|---|
| Cobb angle measurementsPA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year | Diagnostic test | 50 - 25 % EWL, < 25 % EWL, > 50 %EWL |
Primary outcome
Cobb angle measurements
Time frame: 2 years
Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.
2 secondary outcomes
% EWL measurements
Time frame: 2 years
Patient satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- 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.
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?
A study testing Cobb angle measurements in people with Obesity, Morbid and Back Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. 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 Turkey (Türkiye). 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?
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?
Cobb angle measurements (time frame: 2 years). 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 14 Apr 2021.