Physiological Predictors of Clinical Outcomes After Anti-reflux Surgery

NCT03390634 | Completed

• 1 other identifier: 238959
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-oesophageal reflux disease (GORD) is a common condition, where acid from the stomach leaks up into the oesophagus (gullet) and causes symptoms such as heartburn and an unpleasant taste in the back of the mouth. GORD can often be controlled with self-help measures and medication. Occasionally, surgery to correct the problem may be needed. A laparoscopic fundoplication is a keyhole (laparoscopic) procedure which is a highly effective treatment. Although reflux-related symptoms are absent or well controlled in over 85% of patients at 5 years after the operation, younger patients may have higher expectations that such an operation would hopefully last decades. Oesophageal physiology tests such as 24-hour catheter pH (potential of hydrogen) and impedance involve passing a small tube into oesophagus via patients' nose to monitor the presence of stomach content (acid or non-acid) in the oesophagus. The manometry test measures the pressures and coordination of pressure activity within the oesophagus. Bravo™ wireless pH monitoring uses a capsule that is attached to the oesophageal lining. These tests are often used as part of a pre-operative evaluation before anti-reflux surgery (ARS). Several measurements in these tests (also called parameters) could potentially anticipate clinical outcomes following anti-reflux surgery. The evidence for parameters like duration of acid exposure, number of reflux episodes and association with symptoms, pressures and co-ordination of pressure activity in the oesophagus, came from studies which were not designed in the most rigorous way to determine whether a cause-effect relation exists between treatment and outcome. This is a single centre, retrospective, observational study in which patients who had pre-operative physiology testing and anti-reflux surgery at a tertiary centre in the last 10 years will be assessed for reflux symptoms and quality of life over the phone, based on three validated questionnaires. The study is designed to evaluate correlations between oesophageal physiology parameters and symptomatic response to ARS.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (3)

• Reflux Disease Questionnaire (RDQ) score improvement ratio after anti-reflux surgery

  ≥ 50% improvement in RDQ scores is considered a successful outcome

  1 day

• Reflux Symptoms Index (RSI) threshold score after anti-reflux surgery

  RSI score after anti-reflux surgery

  1 day

• Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL) threshold scores after anti-reflux surgery

  GORD-HRQL score after anti-reflux surgery

  1 day

Secondary Outcomes (2)

• Dosage of proton pump inhibitors (PPI) per day after anti-reflux surgery

  1 day

• Number of patients requiring re-do anti-reflux surgery

  1 day

Interventions

Gastroesophageal reflux symptoms questionnaires OTHER

Reflux Disease Questionnaire (RDQ) Reflux Symptoms Index (RSI) Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL)

Eligibility Criteria

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

Study Population

Patients with gastro-oesophageal reflux confirmed on physiology testing and treated with anti-reflux surgery at a single tertiary centre over 10 years.

You may qualify if:

• Males and non-pregnant females over the age of 18 years.
• Gastro-oesophageal symptoms in accordance with Montreal criteria49
• Patients who had oesophageal physiology testing at Guy's and St Thomas' NHS Foundation Trust
• Oesophageal manometry based on Chicago classification
• hour standard pH, impedance-pH and Bravo™
• Minimum 6 months post ARS and follow-up at GSTT
• Verbal consent over the phone

You may not qualify if:

• Patients less than 18 years of age.
• Pregnancy at the time of interview
• Patients unable to comprehend or answer the questionnaires
• Oesophageal physiology tests performed in other centres

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Terry Wong, MA MD

  Consultant Gastroenterologist, Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 4, 2018
• Study Start: March 5, 2018
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)