Obesity
Conditions
Keywords
Bariatric surgery, Binge eating, Anxiety, Depression, Body shape questionnaire, Eating attitude test
Brief summary
The goal of this clinical trial is to learn if the type of weight-loss surgery (sleeve gastrectomy or gastric bypass) affects binge eating, depression, and anxiety in adults with severe obesity. The main questions it aims to answer are: Does sleeve gastrectomy lead to different changes in binge eating compared with gastric bypass? Does the type of surgery lead to different changes in depression and anxiety symptoms? Researchers will compare people who have sleeve gastrectomy with those who have gastric bypass to see if there are differences in binge eating, depression, and anxiety levels up to 12 months after surgery. Participants will: Complete questionnaires about eating habits, mood, anxiety, general health, and body image before surgery. Undergo either a sleeve gastrectomy or a gastric bypass operation (both are standard care). Follow a standard post-surgery diet plan. Attend follow-up visits at 1 week, 2 weeks, 1 month, and then monthly for 12 months, where they will complete the same questionnaires again.
Detailed description
This prospective cohort study compares two standard-of-care bariatric surgical procedures - laparoscopic sleeve gastrectomy (SG) and laparoscopic gastric bypass (Roux-en-Y or one-anastomosis) - with respect to postoperative changes in binge eating, depression, and anxiety. A total of 100 morbidly obese patients (50 per arm) aged 18-60 years with a body mass index ≥35 kg/m² (or ≥30 kg/m² with at least one obesity-related comorbidity) will be recruited from the General Surgery department at Kasr Alainy Teaching Hospital, Cairo University. The choice of procedure is determined by a preoperative multidisciplinary evaluation considering baseline BMI, presence of gastroesophageal reflux disease, type 2 diabetes mellitus, and patient preference after detailed counseling. All operations are performed under general anesthesia; SG uses a 36-Fr bougie. Validated Arabic versions of the following instruments are administered at baseline and at each postoperative visit (1 week, 2 weeks, 1 month, and monthly thereafter for 12 months): Binge Eating Scale (BES) - primary outcome for binge eating Beck Depression Inventory-II (BDI-II) - primary outcome for depression Beck Anxiety Inventory (BAI) - primary outcome for anxiety General Health Questionnaire-28 (GHQ-28) Body Shape Questionnaire-14 (BSQ-14) Eating Attitude Test-26 (EAT-26) Secondary outcomes include changes in GHQ-28, BSQ-14, EAT-26 scores, and weight loss (absolute weight and BMI). Data will be analyzed using SPSS version 27, with appropriate parametric and non-parametric tests for between- and within-group comparisons. The significance level is set at p ≤ 0.05. The study is powered (80%, alpha 5%) to detect a difference in binge eating prevalence between SG (18.4%) and gastric bypass (1.3%) at one year, requiring 92 evaluable patients; 100 will be enrolled to accommodate potential loss to follow-up. The study has been approved by the Cairo University Faculty of Medicine Research Ethics Committee (REC approval number N-64-2026, dated 7 March 2026). All participants provide written informed consent.
Interventions
PROCEDURELaparoscopic Sleeve Gastrectomy
Laparoscopic sleeve gastrectomy performed using a 36-French bougie. The greater curvature of the stomach is resected, creating a tubular gastric sleeve. Standard perioperative care including antibiotic prophylaxis and DVT prophylaxis. Postoperative liquid diet for 15 days, then soft diet for one month, followed by gradual introduction of regular diet avoiding fatty and high-sugar foods.
PROCEDUREGastric Bypass
Gastric bypass surgery performed either as Roux-en-Y gastric bypass (RYGB) or one anastomosis gastric bypass (OAGB) based on preoperative multidisciplinary evaluation. Includes creation of a small gastric pouch and an anastomosis to the small bowel. Standard perioperative and postoperative care same as sleeve gastrectomy.
Sponsors
Cairo University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 60 years * Body Mass Index (BMI) ≥ 35 kg/m² without comorbidities, OR BMI ≥ 30 kg/m² with at least one obesity-related medical comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea, dyslipidemia) * Patient is generally fit for laparoscopic surgery and general anesthesia as determined by preoperative evaluation * Patient agrees to comply with postoperative lifestyle changes (dietary modifications and follow-up schedule) * Willing and able to provide written informed consent
Exclusion criteria
* Age \< 18 years or \> 60 years * Inability or unwillingness to adhere to postoperative lifestyle changes * Contraindication to surgery: American Society of Anesthesiologists (ASA) class IV or higher * History of receiving radiotherapy or chemotherapy for cancer treatment * Active substance use disorder or uncontrolled severe psychiatric illness that would impair ability to comply with study procedures (e.g., active psychosis, severe suicidal ideation) * Pregnant or breastfeeding women (pregnancy test performed preoperatively per institutional protocol) * Previous bariatric surgery (revisional surgery excluded) * Untreated thyroid disorder (e.g., hypothyroidism or hyperthyroidism)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Mental Health Score (Simple Sum) | Baseline, 6 months, 12 months | Simple sum of raw scores from three scales: Binge Eating Scale (BES, 0-46) + Beck Depression Inventory-II (BDI-II, 0-63) + Beck Anxiety Inventory (BAI, 0-63). Minimum total = 0 (best mental health). Maximum total = 172 (worst mental health). Higher score = worse mental health. Primary endpoint is change from baseline to 12 months (lower score = improvement). |
| Binge Eating Scale (BES) Score Change | Baseline, 6 months, 12 months | 16-item self-report questionnaire. Each item scored 0-3. Total raw score range: minimum 0, maximum 46. Higher score = more severe binge eating. Clinical interpretation: 0-17 = no significant binge eating; 18-26 = moderate binge eating; 27-46 = severe binge eating. |
| Beck Depression Inventory-II (BDI-II) Score Change | Baseline, 6 months, 12 months | 21-item self-report inventory. Each item scored 0-3. Total raw score range: minimum 0, maximum 63. Higher score = more severe depression. Clinical interpretation: 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression. |
| Beck Anxiety Inventory (BAI) Score Change | Baseline, 6 months, 12 months | 21-item self-report questionnaire. Each item scored 0-3. Total raw score range: minimum 0, maximum 63. Higher score = more severe anxiety. Clinical interpretation: 0-7 = minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Shape Questionnaire-14 (BSQ-14) Score Change | Baseline, 6 months, 12 months | 14-item self-report measure of body shape satisfaction. Each item scored 1 (never) to 6 (always). Total raw score range: minimum 14, maximum 84. Lower score = greater body shape satisfaction (better). Higher score = lower satisfaction (more dissatisfaction). Clinical interpretation: score ≤ 34 = good satisfaction; score 35-50 = moderate dissatisfaction; score \>50 = marked to severe dissatisfaction (poor satisfaction). |
| General Health Questionnaire-28 (GHQ-28) - Likert Score | Baseline, 6 months, 12 months | 28-item self-report screening tool for minor psychiatric disorders. Likert scoring (0-1-2-3 per item) is used. Total raw score range: minimum 0, maximum 84. Higher score = worse psychological distress. A total score greater than 23 suggests probable psychiatric caseness (anxiety or depression disorder). Four subscales (each 0-21): A = somatic symptoms (items 1-7), B = anxiety/insomnia (8-14), C = social dysfunction (15-21), D = severe depression (22-28). |
| Eating Attitude Test-26 (EAT-26) Score Change | Baseline, 6 months, 12 months | 26-item screening tool for disordered eating attitudes. Scoring: Always=3, Usually=2, Often=1, Sometimes=0, Rarely=0, Never=0. Item 26 is reverse scored (Always=0, Never=3). Total raw score range: minimum 0, maximum 78. Higher score = more pathological eating attitudes. A score of 20 or higher suggests possible eating disorder (anorexia nervosa, bulimia nervosa, or binge eating disorder) and needs clinical interview. |
| Percent Total Weight Loss (%TWL) | 6 months, 12 months | Calculated as: \[(Baseline weight in kg - current weight in kg) / baseline weight in kg\] × 100. Higher percentage = greater weight loss. Can be negative if patient gains weight. Successful weight loss after bariatric surgery is often defined as %TWL ≥ 20% at 12 months. |
| Body Mass Index (BMI) Change | Baseline, 6 months, 12 months | Body Mass Index calculated as weight in kilograms divided by height in meters squared (kg/m²). Weight measured using a calibrated scale; height measured at baseline using a stadiometer. BMI range typically 15-60 kg/m² in this population. Lower BMI indicates healthier weight status. Clinical classification: \<18.5 underweight, 18.5-24.9 normal, 25-29.9 overweight, 30-34.9 obesity class I, 35-39.9 obesity class II, ≥40 obesity class III (severe obesity). |
Countries
Egypt
Contacts
CONTACTAhmed Eid Aziz, Lecturer
Outcome results
None listed