Long Term Incidence and Effect of de Novo GERD After Laparoscopic Sleeve Gastrectomy in Chinese Population

NCT04237857 | Unknown

• 1 other identifier: CRE-2019.362
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the long-term incidence and effects of gastroesophageal reflux disease in the Chinese population after laparoscopic sleeve gastrectomy.

Conditions

Gastroesophageal Reflux

Keywords

Sleeve gastrectomy; Gastroesophageal reflux; Chinese

Outcome Measures

Primary Outcomes (1)

• Incidence of de novo GERD

  Incidence of long term de novo gastroesophageal reflux disease after laparoscopic sleeve gastrectomy, as defined by: Patients who did not have pre-operative GERD; AND patients who scored ≥12 in the Chinese GERDQ questionnaire at ≥36 months after SG; and/or patients who scored ≤5 out of 8 marks in questions 26 (acid reflux) and 34 (heart burn), at ≥36 months after SG; and/or patients who had erosive esophagitis or Barret's esophagus at upper gastrointestinal endoscopy at ≥36 months after SG; and/or patients who required regular anti-reflux medications at ≥36 months after SG

  >36 months after surgery

Secondary Outcomes (3)

• Changes in severity of GERD

  >36 months after surgery

• Proportion of asymptomatic patients with endoscopic evidence of de novo GERD

  >36 months after surgery

• Difference in quality of life in patient with or without de novo GERD

  >36 months after surgery

Study Arms (1)

LSG

Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong for more than 36 months

Procedure: Laparoscopic sleeve gastrectomy

Interventions

Laparoscopic sleeve gastrectomy PROCEDURE

Laparoscopic sleeve gastrectomy

LSG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong for more than 36 months

You may qualify if:

• Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong
• 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

You may not qualify if:

• Revisional surgery
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (17)

• 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.

  PMID: 30921053 BACKGROUND

• 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.

  PMID: 29340679 BACKGROUND

• 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.

  PMID: 29340676 BACKGROUND

• 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.

  PMID: 16928254 BACKGROUND

• 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.

  PMID: 30879011 BACKGROUND

• 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.

  PMID: 30521478 BACKGROUND

• 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.

  PMID: 25855575 BACKGROUND

• 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.

  PMID: 28593484 BACKGROUND

• 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.

  PMID: 30343262 BACKGROUND

• 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.

  PMID: 28235650 BACKGROUND

• 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.

  PMID: 21369488 BACKGROUND

• 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.

  PMID: 23232995 BACKGROUND

• 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.

  PMID: 25964106 BACKGROUND

• 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.

  PMID: 29931481 BACKGROUND

• 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.

  PMID: 22367008 BACKGROUND

• 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.

  PMID: 17011354 BACKGROUND

• 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.

  PMID: 12786635 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yau Fung Cheung, FRCSEd(Gen)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yau Fung Cheung, FRCSEd(Gen)

CONTACT

3505 2956; ericcheung@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)