Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2022-12-15
2024-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
agression before surgery
The group that the aggression assessment when morbidly obese before surgery
laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery will be performed by a single surgeon.
agression after surgery
group reassessed for aggression following postoperative weight loss
laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery will be performed by a single surgeon.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery will be performed by a single surgeon.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fatih Sultan Mehmet Training and Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ANIL ERGIN
Uzman Doktor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
anıl ergin
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANILERGİNNN
Identifier Type: -
Identifier Source: org_study_id