ObesityNCT05654584
Weight Loss and Aggression
An observational study of Obesity and Obesity, Morbid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Obesity has become an important medical and social problem in western countries today. Although many surgical procedures are performed for obesity, Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obesity, Morbid, Aggression
- What is being tested?
- laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing laparoscopic sleeve gastrectomy were included in the study. It was planned to investigate the changes in aggression rates before and after weight loss by applying aggression questionnaires to all patients.
Who may be able to join
- 18 years and older and younger than 64 years old.
- At least 5 years of morbid obesity (BMI >40 or >35 comorbidity)
- Patients with temporary or inadequate response (less than 10% of body weight will be considered insufficient) weight loss despite diet for at least 6 months before the operation under the guidance of a dietitian.
Who cannot join
- Past upper gastrointestinal surgery,
- Paraesophageal (type 2), mixed (type 3), or sliding hiatal hernias of 3 cm or more,
- Patients with esophagitis and/or Barrett's metaplasia in upper gastrointestinal system (GIS) endoscopy
- Those with peripheral vascular disease Those with a history of cerebrovascular accident
- Patients with coagulopathy
- History of chronic analgesic use
Show all 12Show fewer
- Patients with perioperative complications
- Patients with a previous psychiatric diagnosis other than depression
- Patients who lost less than 10% of their initial weight at the 6th month after the operation
- patients with chronic alcohol use
- patients with recent psychological trauma
- low-income patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34734
anıl ergin, +902165783000, dranilergin@gmail.com
About this study
Official title: Evaluation of the Relationship Between Weight Loss and Aggression After Laparoscopic Sleeve Gastrectomy Surgery
Obesity has become an important medical and social problem in western countries today. Although many surgical procedures are performed for obesity, Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. The absence of digestive anastomosis, the absence of mesenteric defects that may cause internal hernias and foreign materials such as gastric band are among the advantages of this surgical method.
Obesity is a complex multifactorial disease. Obesity is not a mental disorder, but is associated with serious serious conditions and increases the risk of mental disorders. The social label of obesity will have long-lasting devastating effects on mental health. In addition, obesity is associated with undesirable conditions; Misperception of dietary needs, self-perceived health status and potential social isolation, negative attitude towards appearance, aggression, depression, anxiety, attention deficit/hyperactivity disorder, behavioral problem, and bullying are some of the problems associated with obesity. Body changes are important in the experience of being different from their peers and can result in lowered self-esteem and be a barrier to social functioning. Studies on this condition have shown that obese subjects have poor social functioning and social skills.
There are many factors that cause aggression, but obesity is one of them. Although there are many studies examining the relationship between overweight and aggression in children and adolescent patient groups, studies examining the adult patient group are limited. Starting from this point, we aimed to determine the change in aggression after weight loss in patients who underwent LSG surgery in the study we created.
Read the detailed description
Fifty patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included in the study. The number of samples was calculated by performing impact power analysis. Informed consent form and voluntary consent form will be obtained from all patients.
One month before the surgery, the patients will be weighed and their body mass indexes will be calculated. On the same day, patients will have to fill out the Buss-Perry Aggression Scale questionnaire. LSG operation will be applied to all patients as standard. The patients will be weighed again in the 6th month after the operation, and their body mass indexes will be calculated and recorded. The Buss-Perry Aggression Scale questionnaire will be applied to the patients on the same day. Survey results will be saved in excel. Patients who lost less than 10% of their initial weight for surgery within six months will not be included in the study. Validity and Reliability study of the Turkish version of the Buss-Perry Aggression Scale has been done and it has been mentioned in the sources. Patients will be evaluated in terms of age, gender, BMI (body mass index), comorbidities, marital status and whether they have been diagnosed with depression before.
Standard LSG operating procedure: Five trocar techniques are used and the surgeon stands between the patient's legs. After induction of general anesthesia, the patient is placed in the supine inverted Trendeleburg position and the optiview trocar (Ethicon Endo-surgery, Cincinnati Ohio) is used to enter the peritoneal cavity. LSG begins with the division of the vascular supply of the greater curvature of the stomach, the gastrocolic and gastrosplenic ligaments are cut very close to the stomach. The dissection is continued until the left crus of the diaphragm, the gastrophrenic ligament is divided, the gastric fundus is completely freed, and it is ready to be excised. After this step, a 46 Fr(French) boogie is placed in the stomach and gastrectomy provides a tight tube starting from approximately 5 cm proximal to the pylorus. The procedure continues with a longitudinal gastrectomy of the greater cruciate of the stomach. An Echelon stapler is used with the 60mm Echelon Compact Linear Cutter loaded with ECR60D cartridges (Ethicon Endo-Surgery, Inc). The remaining gastric tube has an average volume of 80-200 ml. Areas with staple line bleeding are stopped with surgical clips. After methylene blue is injected into the stomach with the help of an orogastric tube and it is confirmed that there is no leakage from the staple line, the previously separated gastrocolic ligament is sutured to the stomach staple line with a v-lock suture. The folds are closed in the anatomical plane.
- Conditions
- Obesity, Obesity, Morbid, Aggression
- Being tested
- laparoscopic sleeve gastrectomy
- Keywords
- agression, obesity, laparoscopic sleeve gastrectomy, morbid obesity
- Medical subject headings
- Obesity, Obesity, Morbid, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
Laparoscopic sleeve gastrectomy surgery will be performed by a single surgeon.
| Study group | Role | What they receive |
|---|---|---|
| agression before surgery | The group that the aggression assessment when morbidly obese before surgery Receives: Procedure: laparoscopic sleeve gastrectomy | |
| agression after surgery | group reassessed for aggression following postoperative weight loss Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
agression score after weight loss
After significant weight loss in the first year after laparoscopic sleeve gastrectomy, the preoperative aggression questionnaires will be re-administered to all patients.
Measured: 1 year
Secondary outcomes (1)
agression score before weight loss
Aggression questionnaires will be filled in all patients while they are morbidly obese before laparoscopic sleeve gastrectomy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
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
- NCT05654584
- Sponsor's protocol ID
- ANILERGİNNN
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study and patient data can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Weight Loss and Aggression After Laparoscopic Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT05654584
- Acronym / sponsor ID
- ANILERGİNNN
- Conditions
- Obesity, Obesity, Morbid, Aggression
- Keywords
- agression, obesity, laparoscopic sleeve gastrectomy, morbid obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 16 Dec 2022 (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 important medical and social problem in western countries today. Although many surgical procedures are performed for obesity, Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. The absence of digestive anastomosis, the absence of mesenteric defects that may cause internal hernias and foreign materials such as gastric band are among the advantages of this surgical method.
Obesity is a complex multifactorial disease. Obesity is not a mental disorder, but is associated with serious serious conditions and increases the risk of mental disorders. The social label of obesity will have long-lasting devastating effects on mental health. In addition, obesity is associated with undesirable conditions; Misperception of dietary needs, self-perceived health status and potential social isolation, negative attitude towards appearance, aggression, depression, anxiety, attention deficit/hyperactivity disorder, behavioral problem, and bullying are some of the problems associated with obesity. Body changes are important in the experience of being different from their peers and can result in lowered self-esteem and be a barrier to social functioning. Studies on this condition have shown that obese subjects have poor social functioning and social skills.
There are many factors that cause aggression, but obesity is one of them. Although there are many studies examining the relationship between overweight and aggression in children and adolescent patient groups, studies examining the adult patient group are limited. Starting from this point, we aimed to determine the change in aggression after weight loss in patients who underwent LSG surgery in the study we created.
Detailed description
Fifty patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included in the study. The number of samples was calculated by performing impact power analysis. Informed consent form and voluntary consent form will be obtained from all patients.
One month before the surgery, the patients will be weighed and their body mass indexes will be calculated. On the same day, patients will have to fill out the Buss-Perry Aggression Scale questionnaire. LSG operation will be applied to all patients as standard. The patients will be weighed again in the 6th month after the operation, and their body mass indexes will be calculated and recorded. The Buss-Perry Aggression Scale questionnaire will be applied to the patients on the same day. Survey results will be saved in excel. Patients who lost less than 10% of their initial weight for surgery within six months will not be included in the study. Validity and Reliability study of the Turkish version of the Buss-Perry Aggression Scale has been done and it has been mentioned in the sources. Patients will be evaluated in terms of age, gender, BMI (body mass index), comorbidities, marital status and whether they have been diagnosed with depression before.
Standard LSG operating procedure: Five trocar techniques are used and the surgeon stands between the patient's legs. After induction of general anesthesia, the patient is placed in the supine inverted Trendeleburg position and the optiview trocar (Ethicon Endo-surgery, Cincinnati Ohio) is used to enter the peritoneal cavity. LSG begins with the division of the vascular supply of the greater curvature of the stomach, the gastrocolic and gastrosplenic ligaments are cut very close to the stomach. The dissection is continued until the left crus of the diaphragm, the gastrophrenic ligament is divided, the gastric fundus is completely freed, and it is ready to be excised. After this step, a 46 Fr(French) boogie is placed in the stomach and gastrectomy provides a tight tube starting from approximately 5 cm proximal to the pylorus. The procedure continues with a longitudinal gastrectomy of the greater cruciate of the stomach. An Echelon stapler is used with the 60mm Echelon Compact Linear Cutter loaded with ECR60D cartridges (Ethicon Endo-Surgery, Inc). The remaining gastric tube has an average volume of 80-200 ml. Areas with staple line bleeding are stopped with surgical clips. After methylene blue is injected into the stomach with the help of an orogastric tube and it is confirmed that there is no leakage from the staple line, the previously separated gastrocolic ligament is sutured to the stomach staple line with a v-lock suture. The folds are closed in the anatomical plane.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| agression before surgery | – | Procedure: laparoscopic sleeve gastrectomyThe group that the aggression assessment when morbidly obese before surgery |
| agression after surgery | – | Procedure: laparoscopic sleeve gastrectomygroup reassessed for aggression following postoperative weight loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing laparoscopic sleeve gastrectomy were included in the study. It was planned to investigate the changes in aggression rates before and after weight loss by applying aggression questionnaires to all patients.
Key inclusion criteria (3 listed)
- 18 years and older and younger than 64 years old.
- At least 5 years of morbid obesity (BMI >40 or >35 comorbidity)
- Patients with temporary or inadequate response (less than 10% of body weight will be considered insufficient) weight loss despite diet for at least 6 months before the operation under the guidance of a dietitian.
Key exclusion criteria (12 listed)
- Past upper gastrointestinal surgery,
- Paraesophageal (type 2), mixed (type 3), or sliding hiatal hernias of 3 cm or more,
- Patients with esophagitis and/or Barrett's metaplasia in upper gastrointestinal system (GIS) endoscopy
- Those with peripheral vascular disease Those with a history of cerebrovascular accident
- Patients with coagulopathy
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 |
|---|---|---|
| laparoscopic sleeve gastrectomyLaparoscopic sleeve gastrectomy surgery will be performed by a single surgeon. | Procedure or surgery | agression after surgery, agression before surgery |
Primary outcome
agression score after weight loss
Time frame: 1 year
After significant weight loss in the first year after laparoscopic sleeve gastrectomy, the preoperative aggression questionnaires will be re-administered to all patients.
1 secondary outcome
agression score before weight loss
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: Undecided. Study and patient data can be shared upon request.
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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.
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 Obesity and Obesity, Morbid, 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 3 inclusion and 12 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 16 Dec 2022. 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?
Contact ANIL ERGİN (+905342245364, dranilergin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
agression score after weight loss (time frame: 1 year). 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 16 Dec 2022.