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Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03488147
Recruitment Status : Suspended (Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol.)
First Posted : April 4, 2018
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Hecht, Icahn School of Medicine at Mount Sinai

Brief Summary:
The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.

Condition or disease Intervention/treatment Phase
Dysphagia GERD Degenerative Joint Disease Drug: Esomeprazole Drug: Placebo Oral Tablet Phase 2

Detailed Description:

Over half of patients who underwent anterior cervical surgery may experience dysphagia in the month following the operation. Dysphagia, characterized as difficulty swallowing foods and/or liquids, is a debilitating condition that not only reduces the quality of life for our patients but also results in poor nutritional intake, which may lead to delays in healing and recovery after surgery.

Current understanding of dysphagia following cervical surgery is very rudimentary. Many published reports were retrospective studies where the incidence of dysphagia was later found to be greatly underreported. Furthermore, many studies utilized small sample sizes producing varying data regarding the incidence and severity of postoperative dysphagia. Most importantly, a review of the medical literature failed to find any consistently proven recommendations or therapies that can reduce the incidence or severity of postoperative dysphagia.

A recently published study shows that gastroesophageal reflux disease (GERD) is also a common complaint following anterior cervical surgery. The study also shows a positive correlation between the severity of postoperative GERD and severity of postoperative dysphagia. Other studies also showed that patients suffering from GERD-associated dysphagia may be successfully treated with proton pump inhibitors. Based on these studies, along with anecdotal reports, the investigators hypothesize that proton pump inhibitors may reduce the incidence and/or severity of dysphagia following anterior cervical surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After consent has been obtained, eligible subjects will be randomized into 1 of 3 different treatment groups designated A, B, and C, using a random number generator.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Subjects assigned to the treatment group 'A' will receive one 20 mg esomeprazole tablet daily starting 1 week prior to the cervical operation and will continue to receive the esomeprazole until the end of the study (12 week follow-up).

Subjects belonging to the treatment group 'B' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation. Subjects will then receive one 20 mg esomeprazole daily starting immediately after the operation and will continue to receive the esomeprazole until the end of the study.

Subjects belonging to the treatment group 'C' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation and will continue to receive the placebo tablet until the end of the study (12 week follow-up).

Primary Purpose: Treatment
Official Title: The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2, 2021
Estimated Study Completion Date : April 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Esomeprazole Only
Subjects assigned to the treatment group 'A' will receive one 20 mg esomeprazole tablet daily starting 1 week prior to the cervical operation and will continue to receive the esomeprazole until the end of the study
Drug: Esomeprazole
20 mg esomeprazole tablet

Active Comparator: Esomeprazole and Placebo Oral Tablet
Subjects belonging to the treatment group 'B' will receive one placebo tablet (physically resembling an esomeprazole tablet 20 mg ) daily starting one week prior to the cervical operation. Subjects will then receive one 20 mg esomeprazole daily starting immediately after the operation and will continue to receive the esomeprazole until the end of the study.
Drug: Esomeprazole
20 mg esomeprazole tablet

Drug: Placebo Oral Tablet
resembling esomeprazole tablet

Placebo Comparator: Placebo Oral Tablet Only
Subjects belonging to the treatment group 'C' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation and will continue to receive the placebo tablet until the end of the study
Drug: Placebo Oral Tablet
resembling esomeprazole tablet




Primary Outcome Measures :
  1. Dysphagia questionnaire [ Time Frame: 12 weeks post surgery ]
    The Dysphagia questionnaire is a 2 item questionnaire with full scale from 0 (no swallowing difficulty) to 10 (frequent swallowing difficulty)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age.
  • Scheduled to undergo anterior cervical surgery for degenerative joint disease.

Exclusion Criteria:

  • Patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease.
  • Patients with preoperative dysphagia.
  • Patients currently taking any acid suppressing medications (proton pump inhibitors, H2 blockers, antacids, etc).
  • Patients who are pregnant or nursing.
  • Patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole.
  • Patients unable to attend follow-up visits or answer the dysphagia questionnaires.

Eligibility Criteria:

  • Scheduled to undergo anterior cervical surgery for degenerative joint disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488147


Locations
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United States, New York
Mount Sinai West
New York, New York, United States, 10019
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Andrew C Hecht, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Andrew Hecht, Assistant Professor, Chief, Spine Surgery, Director, Mount Sinai Spine Center, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03488147    
Other Study ID Numbers: GCO 12-1433
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andrew Hecht, Icahn School of Medicine at Mount Sinai:
Esomeprazole Magnesium
Postoperative dysphagia
Gastroesophageal reflux disease
Anterior cervical surgery
Proton pump inhibitor
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action