Influence of Wrap Fixation Technique on the Results of Fundoplication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 主要终点
- Slipped wrap
研究概览
简要总结
Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20 - 80 years;
- •Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
- •HH type I, II
排除标准
- •Age < 20 years and > 80 years;
- •Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
- •HH type III, IV;
- •BMI < 16 and > 45 kg/m²;
- •Pregnancy (in females);
- •Oesophageal motility disorders;
- •Oesophageal peptic strictures;
- •Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
- •History of oesophageal/gastric/duodenal surgery including vagotomy;
- •Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
研究组 & 干预措施
Nissen fundoplication with fixation of the wrap
In this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. .
干预措施: Nissen Fundoplication with wrap fixation (Procedure)
Nissen fundoplication without fixation of the wrap
Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.
干预措施: Nissen Fundoplication without wrap fixation (Procedure)
结局指标
主要结局
Slipped wrap
时间窗: 60 months
Slipped wrap will be assessed by barium contrast swallow study
Recurrence rate of hiatal hernia
时间窗: 60 months
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
次要结局
- Quality of life and satisfaction(60 months)
研究者
Grubnik Volodymyr
MD, Professor
Odessa National Medical University