High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of persistent postoperative IEM
研究概览
简要总结
This is a combined retro- and prospective, monocentric study. All patients who underwent or are planned for laparoscopic partial fundoplication (180° anterior or 270° posterior) between 2020-2023 are assessed for preoperative ineffective esophageal motility (IEM).
The main hypothesis is, that preoperative oesophageal motility disorders, especially hypo-contractility or failed peristalsis, are caused by gastro-oesophageal reflux. Therefore, postoperative manometry after partial wrap fundoplication (270° posterior, 180° anterior) shows a decrease in comparison to preoperative motility disorders.
The primary objective of this study is to examine the postoperative esophageal motility in patients with known preoperative motility disorders.
Secondary endpoints are the presence of other oesophageal motility disorders pre- vs. postoperatively (including new onset disorders), the assessment of the Gastrointestinal Symptom Rating Scale (GSRS) pre- vs. postoperatively, and more.
If IEM is present preoperatively, patients are contacted at least 1 year after surgery and will be informed about the study and asked to participate. In case of agreement, they are invited to the study site. They undergo high-resolution manometry 18-24 months postoperatively (study intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years
- •Ineffective esophageal motility disorder according the Chicago classification (7), defined as ≥ 7/10 (70%) of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 5/10 (50%) of swallows with failed peristalsis (DCI <100mgHg/s/cm)Performance of partial fundoplication (180° anterior or 270° posterior) at Spital Limmattal
- •Informed Consent as documented by signature
排除标准
- •Age under 18 years
- •Pregnancy
- •Normal preoperative esophageal motility
- •Other specifically defined esophageal motility disorders such as Nutcracker or Jackhammer esophagus
- •Preoperative presence of a hiatal hernia with migration of >20% of stomach in the chest
- •Revisional surgery (after other procedures for reflux or at the hiatus)
研究组 & 干预措施
Main arm
干预措施: high-resolution manometry (Diagnostic Test)
结局指标
主要结局
Incidence of persistent postoperative IEM
时间窗: 1-2 years postoperatively
The primary endpoint is the incidence of persistent postoperative ineffective motility according to the Chicago classification, defined as ≥ 7/10 (70%) of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 5/10 (50%) of swallows with failed peristalsis (DCI \<100mgHg/s/cm), measured in a high-resolution manometry with multiple swallows in patients having undergone laparoscopic partial-wrap 270° posterior or 180° anterior fundoplication.
次要结局
- Presence of other oesophageal motility disorders(1-2 years postoperatively)
- GSRS(1-2 years postoperatively)
研究者
Prof Urs Zingg
Prof. Dr.
Spital Limmattal Schlieren