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

NCT07600411 | Recruiting

• 1 other identifier: N-64-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Bariatric surgery; Binge eating; Anxiety; Depression; Body shape questionnaire; Eating attitude test

Outcome Measures

Primary Outcomes (4)

• Change in Composite Mental Health Score (Simple Sum)

  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

  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

  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

  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

Secondary Outcomes (5)

• Body Shape Questionnaire-14 (BSQ-14) Score Change

  Baseline, 6 months, 12 months

• General Health Questionnaire-28 (GHQ-28) - Likert Score

  Baseline, 6 months, 12 months

• Eating Attitude Test-26 (EAT-26) Score Change

  Baseline, 6 months, 12 months

• Percent Total Weight Loss (%TWL)

  6 months, 12 months

• Body Mass Index (BMI) Change

  Baseline, 6 months, 12 months

Study Arms (2)

Laparoscopic Sleeve Gastrectomy (SG)

EXPERIMENTAL

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.

Procedure: Laparoscopic Sleeve Gastrectomy

Gastric Bypass (One Anastomosis or Roux-en-Y)

ACTIVE COMPARATOR

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.

Procedure: Gastric Bypass

Interventions

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.

Laparoscopic Sleeve Gastrectomy (SG)

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.

Gastric Bypass (One Anastomosis or Roux-en-Y)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity; Bulimia; Anxiety Disorders; Depression

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Central Study Contacts

Ahmed Eid Aziz, Lecturer

CONTACT

+201127060844; Ahmed-eid@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 20, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)