Can EndoFLIP Improve Quality of Life Before and After Fundoplication?

NCT06159972 | Unknown

• 1 other identifier: 6035362
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with reflux disease (heart burn), or a hiatal hernia, who do not get better with medication, may have surgery to help with their symptoms. Unfortunately, there is no agreed upon way to perform the surgery. The investigators are using a new surgical instrument called the EndoFLIP which allows surgeons to take measurements during the operation. The investigators will compare the measurements obtained during surgery with a quality of life score that we will calculate from a questionnaire.

Conditions

GERD; Hiatal Hernia

Outcome Measures

Primary Outcomes (1)

• Intraoperative EndoFLIP and postoperative quality of life using the "GERD health related quality of life" score

  To identify the correlation between intra-operative EndoFLIP measurements of cross-sectional area, distensibility index, and contraction pattern with post-operative symptom severity score for GERD using the "GERD health related quality of life" score.

  4 (four) months

Secondary Outcomes (1)

• Intraop EndoFLIP and preop + postop manometry and pH monitoring

  4 (four) months

Study Arms (1)

EndoFLIP

EXPERIMENTAL

Intraop EndoFLIP measurements

Device: EndoFLIP

Interventions

EndoFLIP DEVICE

EndoFLIP is a small balloon catheter that is inserted through the endoscope at the time of endoscopy.

EndoFLIP

Eligibility Criteria

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

You may qualify if:

• Adult patients undergoing workup for gastroesophageal reflux disease (GERD) and/or symptomatic hiatal hernia who undergo fundoplication AND who undergo fundoplication

You may not qualify if:

• Those with a previous history of hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy
• Inability to provide consent

Sponsors & Collaborators

• Dr. Wiley Chung: lead
• Medtronic: collaborator

Study Sites (1)

KHSC

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wiley Chung, MD MHPE

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nader M Hanna, MBBS, MSc

CONTACT

(613) 549-6666; nader.hanna@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic Surgeon and Assistant Professor

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 7, 2023
• Study Start: January 5, 2023
• Primary Completion: July 5, 2024
• Study Completion: December 31, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)