Recruiting

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

ClinicalTrials.gov IDNCT07600411

PhaseNA

Enrollment100

SponsorCairo University

Age18 Years

SexALL

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Conditions studied

Obesity

About this 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.

Interventions

Procedure: 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.
Procedure: 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.

Primary outcomes

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

Eligibility information

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)

Study locations

Faculty of Medicine Cairo University, Cairo, Al-Manial Cairo 11956 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.