- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02012894
Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.
The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Turin, Italia, 10126
- University of Turin
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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 |
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Obese patients with preoperative GER
Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A)
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Obese patients without preoperative GER
Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in DeMeester's score
Tidsramme: baseline, 24 months after LSG
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Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG.
It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes
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baseline, 24 months after LSG
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in lower esophageal sphincter pressure
Tidsramme: baseline, 24 months after LSG
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Esophageal manometry measures several parameters including lower esophageal sphincter pressure
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baseline, 24 months after LSG
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Change from baseline in amplitude of esophageal peristaltic waves
Tidsramme: baseline, 24 months after LSG
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Esophageal manometry evaluates quality and amplitude of esophageal peristalsis
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baseline, 24 months after LSG
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Change from baseline in grade of esophagitis
Tidsramme: baseline, 24 months after LSG
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Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis
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baseline, 24 months after LSG
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Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score
Tidsramme: Baseline, 24 months after LSG
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Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life
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Baseline, 24 months after LSG
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Fabrizio Rebecchi, MD, University of Turin, Italy
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Apr;27(4):1260-6. doi: 10.1007/s00464-012-2593-9. Epub 2012 Dec 12.
- Petersen WV, Meile T, Kuper MA, Zdichavsky M, Konigsrainer A, Schneider JH. Functional importance of laparoscopic sleeve gastrectomy for the lower esophageal sphincter in patients with morbid obesity. Obes Surg. 2012 Mar;22(3):360-6. doi: 10.1007/s11695-011-0536-5.
- Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.
- Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RGEOB/76
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