High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

Prof Urs Zingg

Status: Enrolling

Conditions: Upper Gastrointestinal Disorder; Esophageal Motility Disorders; Gastroesophageal Reflux

Treatments: Diagnostic Test: high-resolution manometry

Study type: Interventional

Funder types: Other

Identifiers

NCT05132816

2021-01536

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Main arm

Experimental group

Treatment:

Diagnostic Test: high-resolution manometry