Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07600411

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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)

Treatments and study arms

Laparoscopic Sleeve Gastrectomy

Procedure

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.

Gastric Bypass

Procedure

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

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 ChangeBaseline, 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 ChangeBaseline, 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 ChangeBaseline, 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.

Study locations

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Faculty of Medicine Cairo University🇪🇬 Cairo, Al-Manial Cairo, Egypt

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Ahmed Maher Abd Elmonim, Assistant professorContact

Email · Call +201031036313

AhmedContact