- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02618044
Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux
Long Term Effects of Laparoscopic Roux-en-Y Gastric Bypass on Gastro-esophageal Reflux: Clinical Impact of Weakly Acidic Reflux
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.
The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- history of obesity exceeding 5 years
- documented previous weight loss attempts,
- body mass index (BMI)) of 40-50 kg/m2
- age of 18-60 years.
Exclusion Criteria:
- contraindications to pneumoperitoneum
- large esophageal hiatal hernia
- pregnancy,
- drug or alcohol abuse,
- psychological disorders (e.g., bulimia, depression)
- hormonal or genetic obesity-related disease
- previous gastric surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Obese patients without preoperative GER
Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-)
|
Obese patients with preoperative GER
Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of weakly acidic reflux
Tidsramme: preoperatively, 12 and 60 months after LRYGB
|
number of weakly acidic reflux at 24 hour pH impedance monitoring
|
preoperatively, 12 and 60 months after LRYGB
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
GERD-HRQoL clinical score
Tidsramme: preoperatively, 12 and 60 months after LRYGB
|
Standard and previous validated questionnaire was employed in the study to assess gastroesophageal function and quality of life
|
preoperatively, 12 and 60 months after LRYGB
|
Lower esophageal sphincter pressure
Tidsramme: preoperatively, 12 and 60 months after LRYGB
|
Esophageal manometry measures lower esophageal sphincter pressure
|
preoperatively, 12 and 60 months after LRYGB
|
Amplitude of esophageal peristaltic waves
Tidsramme: preoperatively, 12 and 60 months after LRYGB
|
Esophageal manometry evaluates amplitude of esophageal peristalsis
|
preoperatively, 12 and 60 months after LRYGB
|
Grade of esophagitis
Tidsramme: preoperatively, 12 and 60 months after LRYGB
|
Upper endoscopy is performed to assess the presence of esophagitis
|
preoperatively, 12 and 60 months after LRYGB
|
Number of acidic reflux
Tidsramme: preoperatively, 12 and 60 months after LRYGB
|
number of acidic reflux at 24 hour pH impedance monitoring
|
preoperatively, 12 and 60 months after LRYGB
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Vela MF. Non-acid reflux: detection by multichannel intraluminal impedance and pH, clinical significance and management. Am J Gastroenterol. 2009 Feb;104(2):277-80. doi: 10.1038/ajg.2008.23. No abstract available.
- Sundbom M, Hedenstrom H, Gustavsson S. Duodenogastric bile reflux after gastric bypass: a cholescintigraphic study. Dig Dis Sci. 2002 Aug;47(8):1891-6. doi: 10.1023/a:1016429603337.
- Collard JM, Romagnoli R. Roux-en-Y jejunal loop and bile reflux. Am J Surg. 2000 Apr;179(4):298-303. doi: 10.1016/s0002-9610(00)00326-3.
- Mabrut JY, Collard JM, Romagnoli R, Gutschow C, Salizzoni M. Oesophageal and gastric bile exposure after gastroduodenal surgery with Henley's interposition or a Roux-en-Y loop. Br J Surg. 2004 May;91(5):580-5. doi: 10.1002/bjs.4569.
- Barak N, Ehrenpreis ED, Harrison JR, Sitrin MD. Gastro-oesophageal reflux disease in obesity: pathophysiological and therapeutic considerations. Obes Rev. 2002 Feb;3(1):9-15. doi: 10.1046/j.1467-789x.2002.00049.x.
- Rebecchi F, Allaix ME, Ugliono E, Giaccone C, Toppino M, Morino M. Increased Esophageal Exposure to Weakly Acidic Reflux 5 Years After Laparoscopic Roux-en-Y Gastric Bypass. Ann Surg. 2016 Nov;264(5):871-877. doi: 10.1097/SLA.0000000000001775.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WAROB/97
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