跳至主要内容
临床试验/NCT05872932
NCT05872932已完成2 期

Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment

Sebahattin Celik MD1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2023年12月30日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
131
试验地点
1
主要终点
Quality of life measured using SF-36 questionnaire

研究概览

简要总结

Obesity, which is defined as the accumulation of fat in the body to a degree that impairs health, is defined as a serious public health problem and it is estimated that 13% (approximately 650 million) of the entire world population is obese.

There are different methods in the fight against obesity, one of these methods is bariatric interventions. Although bariatric surgery is the most effective of these procedures, the tendency to endoscopic methods is increasing due to the surgical risk. Gastric balloon is the most common endoscopic method. In addition, gastric botox is among the methods used.

Health consequences of endoscopic interventions have been widely investigating and while gastric balloon recommended as safe and effective method, the situation for gastric botox is controversial.

Although it seems as gastric balloon is an office procedure and safely performed, especially the first week is difficult process for patients. It can also end with abdominal pain, nausea, retching, and eventually a process leading to premature removal of the balloon. In Italian study, Genco et al. reported that out of 2515 patients 11 patients (0.44%) balloon removed due to psychological intolerance. While the reported rate of early gastric balloon removal generally ranges from 0.44% to 16%, De Castro ML. et al. reported the early removal rate as 20%. While the complications related to the gastric balloon are as stated, problems such as nausea, vomiting and cramps after the gastric botox procedure are either not reported or not seen at all.

Therefore, we hypothesize that sequential endoscopic procedures (first botox application followed by gastric balloon placement) will reduce these early complications (abdominal pain, nausea, retching) and early removal of the gastric balloon.

The only study we have reached regarding combined therapy was done in Turkey. Kanlıöz M et al. reported that combining botox and balloon was found to be more effective in losing weight, but it was stated that it had more side effects. In this study, we think that the side effects may already be related to the balloon. As James A et al. stated in their experimental work, the effectiveness of botox is time dependent. It has been stated that the efficacy is optimal after 6 hours in injections to the pyloric region.The fact that the balloon was inserted in the same session, without waiting for enough time after the botox procedure to be effective, may have reduced the possible protective effect of the botox.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •patients with body mass index over 30
  • •patients who have been on a diet and have done sports at least for 6 month and yet could not lose weight.
  • •18-65 years old patients

排除标准

  • •patients diagnosed with peptic ulcer
  • •untraceable patients after injection of botulinum toxin A
  • •patients with no history of bariatric surgery or interventions
  • •patients who do not retrieve balloon after 6 month or require repetitive implantations.

研究组 & 干预措施

Only gastric balloon

Experimental

After analgesia endoscopy will be performed. After diagnostic endoscopy if there is no any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed. For first day standard medication will be provided. Starting from first hour until 1 week, patient nausea -vomiting and retching scores, re-admission to hospital, quality of life scores will be documented. After analgesia endoscopy will be performed. After diagnostic endoscopy if there is not any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed. For first day standard medication will be provided. Starting from first hour until 1 week, patient nausea -vomiting and retching scores, re-admission to hospital, quality of life scores will be documented.

干预措施: gastric balloon implantation (Procedure)

sequential botulinum toxin A injection and then gastric balloon

Experimental

After analgesia endoscopy will be performed. After diagnostic endoscopy if there is not any gastric pathology that would be contraindication for Botox injection and balloon placement, 200 U of botulinum toxin A will be injected to the antrum and the fundus. After 24 hour or 1 week the second procedure (placement of gastric balloon) will be performed. And Starting from first hour until 1 week, patient's nausea-vomiting and retching scores, re-admission to hospital, quality of life scores will be documented.

干预措施: gastric balloon implantation (Procedure)

sequential botulinum toxin A injection and then gastric balloon

Experimental

After analgesia endoscopy will be performed. After diagnostic endoscopy if there is not any gastric pathology that would be contraindication for Botox injection and balloon placement, 200 U of botulinum toxin A will be injected to the antrum and the fundus. After 24 hour or 1 week the second procedure (placement of gastric balloon) will be performed. And Starting from first hour until 1 week, patient's nausea-vomiting and retching scores, re-admission to hospital, quality of life scores will be documented.

干预措施: botulinum toxin A injection (Procedure)

结局指标

主要结局

Quality of life measured using SF-36 questionnaire

时间窗: The questionnaire will be taken 1 week after the balloon placement

The acute(1 week) time frame format of Short Form-36 questionnaire will be used to assess health-related quality of life

Nausea-vomiting and retching measured using Rhodes index of nausea-vomiting-retching(RİNVR)

时间窗: The questionnaire will be taken 6 hours after intragastric balloon placement

Number of patients who develop intolerance and undergo balloon removal procedure

时间窗: First 6 months after intragastric balloon placement

Number of patients who develop intolerance and undergo balloon removal procedure

Number of analgesics and muscle relaxants needed

时间窗: First week after intragastric balloon placement

Weight loss

时间窗: 6 months after intragastric balloon placement

次要结局

未报告次要终点

研究者

发起方
Sebahattin Celik MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sebahattin Celik MD

associate professor

Yuzuncu Yil University

研究点 (1)

Loading locations...

相似试验