Assessing esophageal motility after partial fundoplication for reflux
High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?
NA · Spital Limmattal Schlieren · NCT05132816
This study is testing how a surgery for acid reflux affects the way food moves through the esophagus in patients who have had or will have the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spital Limmattal Schlieren (other) |
| Locations | 1 site (Schlieren, Canton of Zurich) |
| Trial ID | NCT05132816 on ClinicalTrials.gov |
What this trial studies
This study evaluates patients who have undergone or are scheduled for laparoscopic partial fundoplication to treat gastroesophageal reflux. It aims to assess preoperative ineffective esophageal motility and hypothesizes that these motility disorders are caused by reflux. Postoperative high-resolution manometry will be used to determine changes in esophageal motility. The study also examines secondary endpoints, including the presence of new motility disorders and gastrointestinal symptoms before and after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with ineffective esophageal motility disorders who are scheduled for partial fundoplication.
Not a fit: Patients with normal preoperative esophageal motility or specific motility disorders like Nutcracker or Jackhammer esophagus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative outcomes for patients with esophageal motility disorders related to gastroesophageal reflux.
How similar studies have performed: While there is existing research on esophageal motility and fundoplication, this specific approach is novel in its combined retrospective and prospective assessment.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Schlieren, Canton of Zurich
- Spital Limmattal — Schlieren, Canton of Zurich, Switzerland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastroesophageal Reflux, Esophageal Motility Disorders, Upper Gastrointestinal Disorder