ACTRN12622000636752尚未招募未知
Efficacy of laparoscopic fundoplication versus laparoscopic Roux-en-Y gastric bypass for treatment of gastro-oesophageal reflux disease in obese patients; a randomised, controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 182
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Aged greater than or equal to 18 years and less than or equal to 70 years
- •All genders
- •Troublesome symptoms despite maximal medical therapy with 24h pH monitoring (+/- impedence study if locally available) supportive of the diagnosis
- •BMI 30-34.9 with waist circumference >88cm (women) or >102cm (men)
- •BMI 35-40 with any waist-circumference
- •Able and willing to give written consent
- •Willing to perform the questionnaires, investigations and post-operative follow-up required for this study
- •Able to access regular medical care (in the event of post-operative complication such as internal hernia, and for nutritional screening and supplementation measures)
- •Suitable for either surgery
排除标准
- •Intra-thoracic stomach (hiatus hernia with >50% of stomach in thorax)
- •Previous gastro-oesophageal surgery (bariatric, anti-reflux, ulcer, motility disorder)
- •Multiple surgeries in abdominal cavity or previous small bowel pathology or resection
- •Clinical or manometry findings concerning for a severe oesophageal dysmotility syndrome (recognising that clinically silent manometry-defined motility disorders are common in obesity)
- •Any medical condition deemed by an investigator to render the patient ineligible (e.g. conditions that may be exacerbated by gastric bypass surgery such as osteoporosis)
- •Inflammatory bowel disease
- •Pregnant or lactating female (routine pre-operative pregnancy test for all female patients with child-bearing potential)
- •Endocrine cause of obesity
- •Current smoker
- •Drug or alcohol abuse
- •Psychological disorders (e.g. bulimia, depression)
研究者
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