Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07263269

Active, not recruitingNot applicableInterventional

What this study is about

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.

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

Age20 Years to 65 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Patients or their first guardians refusing to participate in the current study. * Previous bariatric surgeries

Treatments and study arms

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 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.

Primary outcomes

Incidence of Dumping Syndrome6 months

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.

Quality of Life Assessment6 months following surgery

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Medicine Cairo University🇪🇬 Cairo, Egypt

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