Trial reportBMC gastroenterology2017
Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial).
Trial report in BMC gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Incidence and risk factors for cholelithiasis after bariatric surgery: a systematic review and meta-analysis.Lipids in health and disease · 2023Pooled it
- European guideline on obesity care in patients with gastrointestinal and liver diseases - Joint European Society for Clinical Nutrition and Metabolism / United European Gastroenterology guideline.United European gastroenterology journal · 2022Guideline
- Ursodeoxycholic Acid Use After Bariatric Surgery: Effects on Metabolic and Inflammatory Blood Markers.Obesity surgery · 2023Trial
- Cost-effectiveness of ursodeoxycholic acid in preventing new-onset symptomatic gallstone disease after Roux-en-Y gastric bypass surgery.The British journal of surgery · 2022Trial
- Risk Factors for Symptomatic Gallstone Disease and Gallstone Formation After Bariatric Surgery.Obesity surgery · 2022Trial
- The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial.Updates in surgery · 2020Trial
- Cholelithiasis after bariatric surgery, incidence, and prophylaxis: randomized controlled trial.Surgical endoscopy · 2020Trial
- The Role of Ursodeoxycholic Acid (UDCA) in Cholelithiasis Management After One Anastomosis Gastric Bypass (OAGB) for Morbid Obesity: Results of a Monocentric Randomized Controlled Trial.Obesity surgery · 2020Trial
- Trial
- Review
- The Management of Biliary Disease in Patients with Severe Obesity Undergoing Metabolic and Bariatric Surgery-An International Expert Survey.Obesity surgery · 2024Article
- Prevalence of elevated alkaline phosphatase levels among post-bariatric surgery patients.Langenbeck's archives of surgery · 2023Article
- Ursodeoxycholic acid for prevention of gallstone disease after laparoscopic sleeve gastrectomy: an Atlantic Canada perspective.Surgical endoscopy · 2023Article
- The Incidence of Cholelithiasis After Bariatric Surgery in Saudi Arabia and Its Associated Risk Factors.Cureus · 2023Article
- Bariatric Surgery: Targeting pancreatic β cells to treat type II diabetes.Frontiers in endocrinology · 2023Review
- Clinical Characteristics of Symptomatic Cholecystitis in Post-Gastrectomy Patients: 11 Years of Experience in a Single Center.Medicina (Kaunas, Lithuania) · 2022Review
- Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations: A 2021 Update.World journal of surgery · 2022Review
- Global Variations in Practices Concerning Roux-en-Y Gastric Bypass-an Online Survey of 651 Bariatric and Metabolic Surgeons with Cumulative Experience of 158,335 Procedures.Obesity surgery · 2020Article
- An inverse association of weight and the occurrence of asymptomatic gallbladder stone disease in hypercholesterolemia patients: a case-control study.Lipids in health and disease · 2020Article
- Recent advances in understanding and managing cholesterol gallstones.F1000Research · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundThe number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA.
methodsA randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. DISCUSSION: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective.
trial registrationNetherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.