NCT05654584

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 8, 2022

Last Update Submit

December 8, 2022

Conditions

Keywords

agressionobesitylaparoscopic sleeve gastrectomymorbid obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • agression score before weight loss

    1 year

Study Arms (2)

agression before surgery

The group that the aggression assessment when morbidly obese before surgery

Procedure: laparoscopic sleeve gastrectomy

agression after surgery

group reassessed for aggression following postoperative weight loss

Procedure: laparoscopic sleeve gastrectomy

Interventions

Laparoscopic sleeve gastrectomy surgery will be performed by a single surgeon.

agression after surgeryagression before surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityObesity, MorbidAggression

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Uzman Doktor

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

December 15, 2022

Primary Completion

December 15, 2023

Study Completion

February 15, 2024

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations