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临床试验/NCT07263269
NCT07263269进行中(未招募)不适用

Assessment of Dumping and Quality of Life 6 Months Following Sleeve Gastrectomy With and Without Transit Bipartition : Comparative Study

Mina Kamal Gergis Erian1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Incidence of Dumping Syndrome

研究概览

简要总结

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.

详细描述

Background and Rationale

Obesity has become one of the most important public-health challenges worldwide. It is associated with a wide range of comorbid conditions such as type 2 diabetes mellitus, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea, degenerative joint disease, and increased cardiovascular morbidity and mortality. Conservative management strategies-including dietary modification, physical activity, and pharmacologic therapy-often result in only modest and temporary weight reduction. Consequently, bariatric and metabolic surgery has emerged as the most effective and durable intervention for achieving long-term weight loss and improvement or remission of obesity-related diseases.

Among the different bariatric procedures, laparoscopic sleeve gastrectomy (LSG) has gained worldwide popularity. It is technically simpler than gastric bypass procedures and does not involve intestinal anastomoses or foreign materials. During LSG, approximately 75-80% of the stomach is resected along the greater curvature, leaving a tubular gastric "sleeve." This results in restrictive limitation of food intake and favorable hormonal changes, such as decreased ghrelin secretion, leading to appetite suppression. LSG has proven effective in producing substantial and durable weight loss as well as improvement in metabolic parameters.

However, despite these benefits, some patients experience functional gastrointestinal symptoms after LSG, including gastroesophageal reflux disease, food intolerance, early satiety, and dumping syndrome. Dumping syndrome refers to a collection of symptoms that occur when food passes too rapidly from the stomach into the small intestine. It can be divided into early dumping (occurring 10-30 minutes after eating, with symptoms such as nausea, abdominal cramps, palpitations, and dizziness) and late dumping (1-3 hours after eating, characterized by hypoglycemia, fatigue, and sweating). These symptoms may significantly impair quality of life (QoL), limit dietary freedom, and affect social activities.

To enhance the metabolic efficacy of sleeve gastrectomy while minimizing complications, several hybrid or modified techniques have been introduced. One such modification is sleeve gastrectomy with transit bipartition (SG-TB). In this operation, a side-to-side anastomosis is created between the distal ileum and the antrum or the first portion of the duodenum, allowing ingested food to pass through both the natural duodenal route and an alternative shortcut to the distal small intestine. This design maintains continuity of the biliary and pancreatic secretions, preserves access to the duodenum for endoscopy, and reduces the risk of nutritional deficiencies commonly seen with complete bypass procedures. Physiologically, the presence of dual intestinal transit is believed to enhance incretin hormone release (GLP-1, PYY) and improve insulin sensitivity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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).

干预措施: Sleeve Gastrectomy (Procedure)

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.

干预措施: Sleeve Gastrectomy with Transit Bipartition (Procedure)

结局指标

主要结局

Incidence of Dumping Syndrome

时间窗: 6 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.

Incidence of Dumping Syndrome

时间窗: 6 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 Assessment

时间窗: 6 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.

次要结局

  • Percentage of Excess Weight Loss (EWL)(6 months post-surgery)
  • Incidence of Surgical Complications(6 months post-surgery)

研究者

发起方
Mina Kamal Gergis Erian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mina Kamal Gergis Erian

General and laparoscopic Surgery Specialist

Cairo University

研究点 (1)

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