Long Term Incidence and Effect of de Novo GERD After Laparoscopic Sleeve Gastrectomy in Chinese Population
NCT ID: NCT04237857
Last Updated: 2023-08-30
Study Results
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Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-02-01
2025-02-01
Brief Summary
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Detailed Description
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One major drawback to SG is potential development of gastrointestinal reflux disease (GERD). According to the Montreal Classification, GERD is defined as heartburn and regurgitation because of reflux contents of the stomach into the esophagus, causing symptoms that interferes with physical activity, disturbs sleep and reduce productivity at work . It has been shown to significant impact on patients' post-operative quality of life negatively . Currently there are discrepancy in the medical literature, while some studies found worsening of GERD or development of GERD (de novo GERD) after SG, some found improvement of GERD post-operatively. From a recent meta-analysis by Yeung et al comprising 10, 718 patients with follow-up period from 3 to 132 months, 19% of patients experienced worsening of GERD while 23% developed de novo GERD after SG.
Furthermore, long term complications of GERD include the development of erosive esophagitis, Barret's esophagus and even esophageal adenocarcinoma. From the same meta-analysis, the long-term prevalence (\>24 months) of erosive esophagitis and Barret's esophagus were 28% and 8% respectively. There have also been isolated case reports of development of esophageal adenocarcinoma after SG. From the investigators' literature review, four cases were reported. Two of the cases had no pre-operative endoscopy, one case had pre-operative diagnosis of Barret's esophagus. The other case developed esophageal adenocarcinoma despite normal pre-operative endoscopy 5 years after SG.
The epidemiology of GERD is different in Western countries and in Asian countries. Although the incidence of GERD has increased in the past decades, the prevalence of GERD was 5.2-8.5% base on symptoms. Prevalence of Barret's esophagus remained rare at 0.06-0.85%. In patents who have received SG, Tai et al showed that the prevalence of GERD increased from 12.1 to 47% based on Reflux Disease Questionnaire at one year after SG. The prevalence of erosive esophagitis also increased from 16.7 to 66.7%. based on upper gastrointestinal endoscopy findings at one year. In the long run, the prevalence of de novo GERD was 17-45% based on symptoms and proton pump inhibitors use from the case series by Pok et al. and Chang et al. with a follow-up period up to 7 years and 10 years respectively.
From the current Asian literature, data on long term incidence of GERD after SG based on objective assessment tools and endoscopy findings was lacking. There is also no adequate data on the long-term occurrence of erosive esophagitis and Barret's esophagus after SG, which would have important significance in pre-operative counselling.
The objective of the study is to evaluate the long-term incidence and effects of gastroesophageal reflux disease in the Chinese population after laparoscopic sleeve gastrectomy.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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LSG
Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong for more than 36 months
Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy
Interventions
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Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy
Eligibility Criteria
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Inclusion Criteria
* SG has been performed more than 36 months
* Patient received preoperative OGD and GI symptom assessment with C-GIQLI questionnaire
* Willing and able to consent to the study
Exclusion Criteria
* Concomitant surgeries (except hiatal repair/ cholecystectomy)
* Mentally incompetent patients or patients less than 18 years old
* Pregnant patients
* Inmates
* Unable/unwilling to consent to the study
* Unable/unwilling to undergo follow-up assessments
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Cheung Yau Fung
Associate Consultant
Principal Investigators
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Yau Fung Cheung, FRCSEd(Gen)
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Yeung KTD, Penney N, Ashrafian L, Darzi A, Ashrafian H. Does Sleeve Gastrectomy Expose the Distal Esophagus to Severe Reflux?: A Systematic Review and Meta-analysis. Ann Surg. 2020 Feb;271(2):257-265. doi: 10.1097/SLA.0000000000003275.
Peterli R, Wolnerhanssen BK, Peters T, Vetter D, Kroll D, Borbely Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.
Salminen P, Helmio M, Ovaska J, Juuti A, Leivonen M, Peromaa-Haavisto P, Hurme S, Soinio M, Nuutila P, Victorzon M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):241-254. doi: 10.1001/jama.2017.20313.
Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
Felsenreich DM, Prager G, Kefurt R, Eilenberg M, Jedamzik J, Beckerhinn P, Bichler C, Sperker C, Krebs M, Langer FB. Quality of Life 10 Years after Sleeve Gastrectomy: A Multicenter Study. Obes Facts. 2019;12(2):157-166. doi: 10.1159/000496296. Epub 2019 Mar 15.
Popescu AL, Ionita-Radu F, Jinga M, Gavrila AI, Savulescu FA, Fierbinteanu-Braticevici C. Laparoscopic sleeve gastrectomy and gastroesophageal reflux. Rom J Intern Med. 2018 Dec 1;56(4):227-232. doi: 10.2478/rjim-2018-0019.
Braghetto I, Csendes A. Prevalence of Barrett's Esophagus in Bariatric Patients Undergoing Sleeve Gastrectomy. Obes Surg. 2016 Apr;26(4):710-4. doi: 10.1007/s11695-015-1574-1.
Felsenreich DM, Kefurt R, Schermann M, Beckerhinn P, Kristo I, Krebs M, Prager G, Langer FB. Reflux, Sleeve Dilation, and Barrett's Esophagus after Laparoscopic Sleeve Gastrectomy: Long-Term Follow-Up. Obes Surg. 2017 Dec;27(12):3092-3101. doi: 10.1007/s11695-017-2748-9.
El Khoury L, Benvenga R, Romero R, Cohen R, Roussel J, Catheline JM. Esophageal adenocarcinoma in Barrett's esophagus after sleeve gastrectomy: Case report and literature review. Int J Surg Case Rep. 2018;52:132-136. doi: 10.1016/j.ijscr.2018.10.015. Epub 2018 Oct 12.
Wright FG, Duro A, Medici JR, Lenzi S, Beskow AF, Cavadas D. Esophageal adenocarcinoma five years after laparoscopic sleeve gastrectomy. A case report. Int J Surg Case Rep. 2017;32:47-50. doi: 10.1016/j.ijscr.2017.01.054. Epub 2017 Feb 11.
Jung HK. Epidemiology of gastroesophageal reflux disease in Asia: a systematic review. J Neurogastroenterol Motil. 2011 Jan;17(1):14-27. doi: 10.5056/jnm.2011.17.1.14. Epub 2011 Jan 26.
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.
Pok EH, Lee WJ, Ser KH, Chen JC, Chen SC, Tsou JJ, Chin KF. Laparoscopic sleeve gastrectomy in Asia: Long term outcome and revisional surgery. Asian J Surg. 2016 Jan;39(1):21-8. doi: 10.1016/j.asjsur.2015.03.006. Epub 2015 May 8.
Chang DM, Lee WJ, Chen JC, Ser KH, Tsai PL, Lee YC. Thirteen-Year Experience of Laparoscopic Sleeve Gastrectomy: Surgical Risk, Weight Loss, and Revision Procedures. Obes Surg. 2018 Oct;28(10):2991-2997. doi: 10.1007/s11695-018-3344-3.
Kasama K, Mui W, Lee WJ, Lakdawala M, Naitoh T, Seki Y, Sasaki A, Wakabayashi G, Sasaki I, Kawamura I, Kow L, Frydenberg H, Chen A, Narwaria M, Chowbey P. IFSO-APC consensus statements 2011. Obes Surg. 2012 May;22(5):677-84. doi: 10.1007/s11695-012-0610-7.
Yeung SM, Shiu AT, Martin CR, Chu KM. Translation and validation of the Chinese version of the Gastrointestinal Quality of Life Index in patients with gastric tumor. J Psychosom Res. 2006 Oct;61(4):469-77. doi: 10.1016/j.jpsychores.2006.03.049.
Wong WM, Lam KF, Lai KC, Hui WM, Hu WH, Lam CL, Wong NY, Xia HH, Huang JQ, Chan AO, Lam SK, Wong BC. A validated symptoms questionnaire (Chinese GERDQ) for the diagnosis of gastro-oesophageal reflux disease in the Chinese population. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1407-13. doi: 10.1046/j.1365-2036.2003.01576.x.
Other Identifiers
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CRE-2019.362
Identifier Type: -
Identifier Source: org_study_id
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