High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

Официальное название

High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?

Обзор

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).

Вмешательства

• Диагностический тест high-resolution manometry
  High-resolution manometry is an outpatient examination and part of our routine diagnostic or pre-operative evaluation in GERD. A thin catheter is placed through the nose into the esophagus, local anaesthesia can be used if the patient experiences a discomfort. Once the tip of the manometry catheter is placed below the esophagogastric junction, the patient is asked to take in water and bread. In rest and during deglutition, pressure measurements are registered with the manometry catheter, allowi

Первичные конечные точки

• Incidence of persistent postoperative IEM [Срок оценки: 1-2 years postoperatively]

Вторичные конечные точки (2)

• Presence of other oesophageal motility disorders [Срок оценки: 1-2 years postoperatively]
• GSRS [Срок оценки: 1-2 years postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Швейцария · 1 центр

• Spital Limmattal — Schlieren

Идентификаторы

NCT: NCT05132816 · 2021-01536

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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