High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

Not Applicable

Recruiting

• Conditions: Upper Gastrointestinal Disorder; Gastroesophageal Reflux; Esophageal Motility Disorders
• Interventions: Diagnostic Test: high-resolution manometry

• Registration Number: NCT05132816
• Lead Sponsor: Prof Urs Zingg

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Study Start: 2022-01-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main arm	high-resolution manometry	-

Primary Outcome Measures

Name	Time	Method
Incidence of persistent postoperative IEM	1-2 years postoperatively	The primary endpoint is the incidence of persistent postoperative ineffective motility according to the Chicago classification, 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), measured in a high-resolution manometry with multiple swallows in patients having undergone laparoscopic partial-wrap 270° posterior or 180° anterior fundoplication.

Secondary Outcome Measures

Name	Time	Method
Presence of other oesophageal motility disorders	1-2 years postoperatively	Presence of other oesophageal motility disorders pre- vs. postoperatively (including new onset disorders) measured in a high-resolution manometry with multiple swallows in patients having undergone laparoscopic partial-wrap 270° posterior or 180° anterior fundoplication.
GSRS	1-2 years postoperatively	Gastrointestinal Symptom Rating Scale (GSRS) pre- vs. postoperatively. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

Trial Locations

Locations (1)

Spital Limmattal; 🇨🇭 Schlieren, ZH, Switzerland