Clinical trial NCT05872932: Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment
Official title: Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: obesity, gastric balloon, botulinum toxin A, intervention
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. patients with body mass index over 30
2. patients who have been on a diet and have done sports at least for 6 month and yet could not lose weight.
3. 18-65 years old patients

Exclusion Criteria:

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

Primary outcomes:
measure: Number of patients who develop intolerance and undergo balloon removal procedure
timeFrame: First 6 months after intragastric balloon placement
measure: Quality of life measured using SF-36 questionnaire
timeFrame: The questionnaire will be taken 1 week after the balloon placement
measure: Nausea-vomiting and retching measured using Rhodes index of nausea-vomiting-retching(RİNVR)
timeFrame: The questionnaire will be taken 6 hours after intragastric balloon placement
measure: Number of analgesics and muscle relaxants needed
timeFrame: First week after intragastric balloon placement
measure: Weight loss
timeFrame: 6 months after intragastric balloon placement
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University Faculty of Medicine
Study officials:
References: