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Binge Eating, Depression and Anxiety Outcomes After Sleeve Gastrectomy Versus Gastric Bypass: A Cohort Study

15. května 2026 aktualizováno: Ahmed Eid Ali Ahmed Aziz, Cairo University

Binge Eating, Depression and Anxiety Outcomes Following Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y or One-Anastomosis Gastric Bypass: A Prospective Cohort Study

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Egypt
    • Al-Manial Cairo
      • Cairo, Al-Manial Cairo, Egypt, 11956
        • Nábor
        • Faculty of medicine Cairo University
        • Kontakt:
          • Ahmed
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Laparoscopic Sleeve Gastrectomy (SG)
Participants undergo laparoscopic sleeve gastrectomy using a 36-French bougie. Standard perioperative and postoperative care according to bariatric surgery protocol. Follow-up at 1 week, 2 weeks, 1 month, then monthly for 12 months. Outcome assessments include Binge Eating Scale (BES), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), GHQ-28, BSQ-14, and EAT-26.
Postup: Laparoscopic 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.
Aktivní komparátor: Gastric Bypass (One Anastomosis or Roux-en-Y)
Participants undergo gastric bypass (either one anastomosis gastric bypass - OAGB, or Roux-en-Y gastric bypass - RYGB) based on preoperative multidisciplinary evaluation. Standard perioperative and postoperative care. Same follow-up schedule and outcome assessments as the SG arm.
Postup: Gastric 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Composite Mental Health Score (Simple Sum)
Časové okno: 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).
Baseline, 6 months, 12 months
Binge Eating Scale (BES) Score Change
Časové okno: 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.
Baseline, 6 months, 12 months
Beck Depression Inventory-II (BDI-II) Score Change
Časové okno: 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.
Baseline, 6 months, 12 months
Beck Anxiety Inventory (BAI) Score Change
Časové okno: 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.
Baseline, 6 months, 12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Body Shape Questionnaire-14 (BSQ-14) Score Change
Časové okno: 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).
Baseline, 6 months, 12 months
General Health Questionnaire-28 (GHQ-28) - Likert Score
Časové okno: 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).
Baseline, 6 months, 12 months
Eating Attitude Test-26 (EAT-26) Score Change
Časové okno: 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.
Baseline, 6 months, 12 months
Percent Total Weight Loss (%TWL)
Časové okno: 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.
6 months, 12 months
Body Mass Index (BMI) Change
Časové okno: 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).
Baseline, 6 months, 12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Cairo University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

11. března 2026

Primární dokončení (Odhadovaný)

1. září 2027

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

15. května 2026

První předloženo, které splnilo kritéria kontroly kvality

15. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • N-64-2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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