NCT04884074|UnknownDMC
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Sponsor study identifier
interventional
50
1 country
1
Study Start
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 7, 2021
Actual (reported)May 12, 2021
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of symptomatic GERD
Defined by GerdQ score \> 7
1 year
The procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR)
The procedure done to this group is the Standard Sleeve Gastrectomy (SSG)
The procedure is performed in a similar fashion as standard sleeve gastrectomy. After gastric mobilization is completed as standard sleeve gastrectomy, the anterior phrenoesophageal ligament is divided and distal 3cm esophagus is mobilized. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist and the hiatus opening is closed with 2/0 non-absorbable suture over the bougie anterior to the esophagus. The hiatus repair was sized by comfortably placement a dissection forceps adjacent to the esophagus without tension. Sleeve gastrectomy is then performed as the standard technique.
Chinese University of Hong Kong
Hong Kong, China
Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg. 2004 Aug;14(7):959-66. doi: 10.1381/0960892041719581.
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.
Tai CM, Huang CK. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Oct;27(10):3937. doi: 10.1007/s00464-013-3022-4. Epub 2013 May 25. No abstract available.
First Submitted
May 7, 2021
First Posted
May 12, 2021
Study Start
Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration
The procedure is performed in French position with a standard 5-port approach and a pneumoperitoneum not exceeding 15mmHg. The greater omentum is then completely detached from the greater curvature of stomach using either ultrasonic or bipolar shear device. All adhesion between posterior gastric wall and pancreatic capsule is freed and the cardia is completely free with left crura completely exposed. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist with its balloon tip reaching the gastric antrum and insufflated with 50cc of air. Sleeve gastrectomy is then performed using laparoscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up cardia at about 1cm lateral to the angle of His, along the Mid-sleeve tube which is lying against the lesser curve of stomach. The staple line is reinforced with absorbable sutures. Distal stomach is anchored at retroperitoneum with non-absorbable stitch.
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Daes J, Jimenez ME, Said N, Dennis R. Improvement of gastroesophageal reflux symptoms after standardized laparoscopic sleeve gastrectomy. Obes Surg. 2014 Apr;24(4):536-40. doi: 10.1007/s11695-013-1117-6.
Wong SK, Lok H, Lam CC, Ng EK. Small Hiatus Hernia and Gastroesophgeal Reflux after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Chinese. Obes Surg. 2014;24(8):1243.
May 1, 2021
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 12, 2021
Record last verified: 2021-04
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