High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorProf Urs Zingg
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Age under 18 years
Pregnancy
Normal preoperative esophageal motility
Other specifically defined esophageal motility disorders such as Nutcracker or Jackhammer esophagus
Trial design
Treatments tested in this trial
- high-resolution manometry
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Prof Urs Zingg
Lead sponsor
Spital Limmattal Schlieren
Sponsor institution
Source ClinicalTrials.gov