Weight Loss and Aggression

Obesity Clinical Trial

Official title:

Evaluation of the Relationship Between Weight Loss and Aggression After Laparoscopic Sleeve Gastrectomy Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05654584
• Other study ID #: ANILERGINNN
• Status: Not yet recruiting
• Start date: December 15, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: December 2022
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: ANIL ERGIN
• Phone: +905342245364
• Email: dranilergin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Aggression
• Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery will be performed by a single surgeon.

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	agression score before weight loss	Aggression questionnaires will be filled in all patients while they are morbidly obese before laparoscopic sleeve gastrectomy.	1 year