High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

NCT05132816 | Recruiting

• 1 other identifier: 2021-01536
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroesophageal Reflux; Esophageal Motility Disorders; Upper Gastrointestinal Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of persistent postoperative IEM

  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.

  1-2 years postoperatively

Secondary Outcomes (2)

• Presence of other oesophageal motility disorders

  1-2 years postoperatively

• GSRS

  1-2 years postoperatively

Study Arms (1)

Main arm

EXPERIMENTAL

Diagnostic Test: high-resolution manometry

Interventions

high-resolution manometry DIAGNOSTIC_TEST

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, allowing the investigator to detect IEM. The examination takes about 1.5 hours. The manometry is a standard and routine intervention being performed for over 30 years with minimal risks. The GSRS questionnaire pre- and postoperatively is part of our standard workup, no additional assessment for this study is needed.

Also known as: Gastrointestinal Symptom Rating Scale (GSRS) - questionnaire

Main arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof Urs Zingg: lead

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophageal Motility Disorders; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 24, 2021
• Study Start: January 24, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)