Thinking of joining a study?

Register your interest

NCT05872932 | Recruiting | Obesity


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

Sebahattin Celik MD

Information provided by (Responsible Party):

Sebahattin Celik MD

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.

Condition or disease

Obesity

Intervention/treatment

gastric balloon implantation

botulinum toxin A injection

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 126 participants
Masking: Triple
Primary Purpose: Treatment
Official Title: Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment
Actual Study Start Date : December 30, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2024
Arm Intervention/treatment

Experimental: Only gastric balloon

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.

Procedure: gastric balloon implantation

Experimental: sequential botulinum toxin A injection and then gastric balloon

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.

Procedure: gastric balloon implantation

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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.

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Turkey,

Yuzuncu Yil University Faculty of Medicine

Van, Turkey, 65080

Loading...