Actively Recruiting
High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Esophageal Motility Change Postoperatively?
Led by Prof Urs Zingg · Updated on 2025-05-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the changes in esophageal motility after partial fundoplication surgery in patients with gastroesophageal reflux who have preoperative ineffective esophageal motility (IEM). The study aims to examine whether the motility disorders caused by reflux improve following surgery. This combined retrospective and prospective study focuses on patients who underwent or are planned for laparoscopic partial fundoplication between 2020 and 2023. Participants undergo either a 180° anterior or 270° posterior laparoscopic partial fundoplication. Those with preoperative IEM are invited to undergo high-resolution manometry 18 to 24 months after surgery to measure esophageal motility postoperatively. The Gastrointestinal Symptom Rating Scale (GSRS) is also assessed before and after surgery to evaluate symptoms related to digestive health. During the study, patients complete manometry tests which involve placing a thin catheter through the nose into the esophagus to record pressure measurements while swallowing water and bread. This outpatient procedure takes about 1.5 hours. Researchers measure the persistence of postoperative IEM and other motility disorders, along with symptom changes using the GSRS. Follow-up occurs at least one year after surgery, with outcomes assessed 1 to 2 years postoperatively.
CONDITIONS
Brief 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
- Diagnosed 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 or planned for laparoscopic partial fundoplication (180° anterior or 270° posterior)
- Able and willing to provide informed consent
You will not qualify if you...
- Age under 18 years
- Pregnancy
- Normal preoperative esophageal motility
- Other defined esophageal motility disorders such as Nutcracker or Jackhammer esophagus
- Presence of a hiatal hernia with more than 20% of stomach migrating into the chest
- Previous revisional surgery after other reflux or hiatus procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1.5 hours per examination
Participants undergo high-resolution manometry, an outpatient examination where a thin catheter is placed through the nose into the esophagus to measure pressure and detect esophageal motility disorders. This is part of routine diagnostic and pre-operative evaluation.
1 preoperative visit and 1 postoperative visit within 1 to 2 years
Duration - 1 to 2 years
Participants are monitored for the persistence of postoperative ineffective esophageal motility and other esophageal motility disorders over 1 to 2 years postoperatively, including completion of symptom questionnaires as part of standard care.
Visits aligned with routine follow-up within 1 to 2 years
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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