Clinical Research Directory
Browse clinical research sites, groups, and studies.
High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
Sponsor: Prof Urs Zingg
Summary
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).
Official title: High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-01-24
Completion Date
2027-12-31
Last Updated
2025-05-15
Healthy Volunteers
No
Interventions
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, allowing the investigator to detect IEM. The examination takes about 1.5 hours. The manometry is a standard and routine intervention being performed for over 30 years with minimal risks. The GSRS questionnaire pre- and postoperatively is part of our standard workup, no additional assessment for this study is needed.
Locations (1)
Spital Limmattal
Schlieren, Canton of Zurich, Switzerland