Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05132816

High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

Led by Prof Urs Zingg · Updated on 2025-05-15

100

Participants Needed

1

Research Sites

309 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 18 years
  • Ineffective esophageal motility disorder according to the Chicago classification, defined as at least 7 out of 10 swallows with weak contraction or at least 5 out of 10 swallows with failed peristalsis
  • Undergoing partial fundoplication (180° anterior or 270° posterior) at Spital Limmattal
  • Provided informed consent by signing
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • Normal preoperative esophageal motility
  • Other specific esophageal motility disorders such as Nutcracker or Jackhammer esophagus
  • Presence of hiatal hernia with more than 20% of stomach migrated into the chest before surgery
  • Previous revisional surgery for reflux or at the hiatus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Spital Limmattal

Schlieren, Canton of Zurich, Switzerland, 8952

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux | DecenTrialz