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High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

RecruitingNAAges 18 Years - anyAllProf Urs Zingg
NCT05132816 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
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What it tests

  • high-resolution manometry
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Where

1 site
Spital Limmattal
Schlieren, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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