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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Change in Composite Mental Health Score (Simple Sum) [Срок оценки: Baseline, 6 months, 12 months]
• Binge Eating Scale (BES) Score Change [Срок оценки: Baseline, 6 months, 12 months]
• Beck Depression Inventory-II (BDI-II) Score Change [Срок оценки: Baseline, 6 months, 12 months]
• Beck Anxiety Inventory (BAI) Score Change [Срок оценки: Baseline, 6 months, 12 months]

Вторичные конечные точки (5)

• Body Shape Questionnaire-14 (BSQ-14) Score Change [Срок оценки: Baseline, 6 months, 12 months]
• General Health Questionnaire-28 (GHQ-28) - Likert Score [Срок оценки: Baseline, 6 months, 12 months]
• Eating Attitude Test-26 (EAT-26) Score Change [Срок оценки: Baseline, 6 months, 12 months]
• Percent Total Weight Loss (%TWL) [Срок оценки: 6 months, 12 months]
• Body Mass Index (BMI) Change [Срок оценки: Baseline, 6 months, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Medicine Cairo University — Cairo

Идентификаторы

NCT: NCT07600411 · N-64-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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