High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
NCT ID: NCT05132816
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-01-24
2027-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Main arm
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Prof Urs Zingg
OTHER
Responsible Party
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Prof Urs Zingg
Prof. Dr.
Locations
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Spital Limmattal
Schlieren, Canton of Zurich, Switzerland
Countries
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Facility Contacts
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Other Identifiers
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2021-01536
Identifier Type: -
Identifier Source: org_study_id
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