Építés alatt – nem éles oldal
Belépés

NCT05872932Befejeződött2/3. fázis

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jan. 22.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Fázis (regiszter)
2/3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
131 (tényleges)
Első benyújtás
2023. febr. 19.
Kezdés
2023. dec. 30.
Elsődleges befejezés
2024. jún. 30.
Fő szponzor
Sebahattin Celik MD
Betegségek
Elhízás
NCT-szám
NCT05872932

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
  • Bevont résztvevők: 131
  • 2023. dec. 30. és az elsődleges befejezés (2024. jún. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Más betegség

  • patients diagnosed with peptic ulcer
  • patients with no history of bariatric surgery or interventions

Egyéb

  • untraceable patients after injection of botulinum toxin A
  • patients who do not retrieve balloon after 6 month or require repetitive implantations.

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Yuzuncu Yil University Faculty of MedicineVanTörökországIsmeretlen állapot

Te vagy a koordinátor? Erősítsd meg az adatokat

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.