High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high-resolution manometry.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux, Esophageal Motility Disorders, Upper Gastrointestinal Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?
Overview
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).
Interventions
- Diagnostic test 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, allowi
Primary outcome measures
- Incidence of persistent postoperative IEM [Time frame: 1-2 years postoperatively]
Secondary outcome measures (2)
- Presence of other oesophageal motility disorders [Time frame: 1-2 years postoperatively]
- GSRS [Time frame: 1-2 years postoperatively]
Eligibility criteria
Inclusion criteria
- Age older than 18 years
- 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
- Age under 18 years
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- Spital Limmattal — Schlieren
Identifiers
NCT: NCT05132816 · 2021-01536