Comparing Dumping Symptoms and Quality of Life 6 Months After Sleeve Gastrectomy With or Without Transit Bipartition in Adults With Obesity

NCT07263269 | Active Not Recruiting

• 1 other identifier: MD-109-2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to compare two types of bariatric (weight loss) surgery used to treat obesity: sleeve gastrectomy alone and sleeve gastrectomy with transit bipartition. Both procedures help patients lose excess weight and improve obesity-related conditions such as diabetes and high blood pressure. However, they may differ in how they affect digestion and patients' quality of life after surgery. One possible complication after bariatric surgery is dumping syndrome. This occurs when food passes too quickly from the stomach into the small intestine, causing symptoms such as nausea, bloating, abdominal pain, diarrhea, dizziness, or fatigue after eating. These symptoms can be uncomfortable and may interfere with daily activities, eating habits, and overall well-being. The main goal of this study is to evaluate and compare both the occurrence of dumping syndrome and the overall quality of life six months after surgery in two groups of patients: Those who undergo sleeve gastrectomy alone. Those who undergo sleeve gastrectomy combined with transit bipartition. Participants will be adults with obesity who are scheduled to undergo bariatric surgery. Each participant will be evaluated before and after surgery using medical assessments and validated questionnaires that measure symptoms, eating patterns, and different aspects of quality of life-including physical health, emotional well-being, and social functioning. Follow-up visits and questionnaires will be conducted six months after surgery to determine how each surgical technique affects patients' digestion, comfort after meals, and overall satisfaction with their health and lifestyle. The study's hypothesis is that adding transit bipartition to sleeve gastrectomy may decrease the frequency or severity of dumping syndrome and lead to better quality of life outcomes compared to sleeve gastrectomy alone. By comparing these two surgical approaches, this study hopes to help surgeons and patients make better-informed decisions about bariatric surgery, aiming for the best combination of effective weight loss, minimal side effects, and improved long-term quality of life.

Conditions

Dumping Syndrome; Postgastrectomy Syndrome; Quality of Life; Bariatric Surgery; Gastrointestinal Function Disorders; Gastrointestinal Transit; Nutritional Status; Patient-reported Outcome Measures; Obesity; Morbid Obesity; Metabolic Diseases; Sleeve Gastrectomy

Keywords

Sleeve Gastrectomy; Transit Bipartition; Bariatric Surgery; Metabolic Surgery; Dumping Syndrome; Postgastrectomy Syndrome; Quality of Life; Obesity; Morbid Obesity; Gastrointestinal Function; Postoperative Complications; Weight Loss Outcomes; Gastrointestinal Transit; Metabolic Outcomes; Patient-Reported Outcomes; Comparative Study

Outcome Measures

Primary Outcomes (2)

• Incidence of Dumping Syndrome

  he primary outcome measure is the incidence of dumping syndrome, assessed through patient-reported symptoms and clinical evaluation. Dumping syndrome is characterized by symptoms like nausea, diarrhea, and dizziness that occur after eating, primarily due to rapid gastric emptying.

  6 months

• Quality of Life Assessment

  The quality of life will be assessed using a validated questionnaire, such as the Short Form 36 (SF-36) or Gastrointestinal Quality of Life Index (GIQLI), focusing on physical, emotional, and social well-being. These tools evaluate how the participants feel about their overall health, function, and the impact of their surgery. Key factors include general health perceptions, physical functioning, pain, emotional well-being, and social interactions.

  6 months following surgery

Secondary Outcomes (2)

• Percentage of Excess Weight Loss (EWL)

  6 months post-surgery

• Incidence of Surgical Complications

  6 months post-surgery

Study Arms (2)

Sleeve Gastrectomy (LSG) Group

ACTIVE COMPARATOR

This group will undergo the standard sleeve gastrectomy (LSG) procedure, where a large portion of the stomach is removed, leaving a tube-like structure. The effects of this procedure on dumping syndrome and quality of life will be assessed and compared to the SG-TB group. Intervention: Sleeve gastrectomy surgery (no transit bipartition).

Procedure: Sleeve Gastrectomy

Sleeve Gastrectomy with Transit Bipartition (SG-TB) Group

EXPERIMENTAL

Participants will undergo sleeve gastrectomy combined with transit bipartition, a modified procedure involving the rerouting of part of the small intestine. Outcomes regarding dumping syndrome and quality of life will be evaluated and compared with the LSG group.

Procedure: Sleeve Gastrectomy with Transit Bipartition

Interventions

Sleeve Gastrectomy PROCEDURE

Sleeve gastrectomy is a weight loss surgery where approximately 75-80% of the stomach is surgically removed, leaving a narrow, tube-like structure. This reduces the stomach's volume, limiting food intake, and promoting weight loss. It is often performed laparoscopically and requires no rerouting of the intestines. The procedure is commonly used to treat morbid obesity and related metabolic conditions.

Sleeve Gastrectomy (LSG) Group

Sleeve Gastrectomy with Transit Bipartition PROCEDURE

This modified version of sleeve gastrectomy involves both the removal of a large portion of the stomach and the rerouting of a part of the small intestine (transit bipartition). This alteration changes the gut hormone response, potentially reducing the risk of dumping syndrome and improving metabolic outcomes. Like LSG, it is typically performed laparoscopically and focuses on both weight loss and gastrointestinal function modification.

Sleeve Gastrectomy with Transit Bipartition (SG-TB) Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI exceeding 40 kg/m2
• BMI exceeding 35 kg/m2, when diagnosed with obesity-related diseases, including type 2 diabetes, hypertension, lipid disorders, and obstructive sleep apnea.
• Obtain informed written consent from the patients or their first guardians
• Patients choosing LSG or LSTB after being offered all suitable bariatric procedures

You may not qualify if:

• Patients or their first guardians refusing to participate in the current study.
• Previous bariatric surgeries

Sponsors & Collaborators

• Mina Kamal Gergis Erian: lead
• Kasr El Aini Hospital: collaborator

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Berg P, McCallum R. Dumping Syndrome: A Review of the Current Concepts of Pathophysiology, Diagnosis, and Treatment. Dig Dis Sci. 2016 Jan;61(1):11-8. doi: 10.1007/s10620-015-3839-x. Epub 2015 Sep 22.

  PMID: 26396002 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Dumping Syndrome; Postgastrectomy Syndromes; Metabolic Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General and laparoscopic Surgery Specialist

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: April 6, 2024
• Primary Completion: June 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

EG (1)