Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Spital Limmattal
Schlieren, Canton of Zurich, Switzerland, 8952
Actively Recruiting
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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