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

• ClinicalTrials.gov Identifier: NCT03488147
• Recruitment Status: Withdrawn
• First Posted: April 4, 2018
• Last Update Posted: November 23, 2020
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Andrew Hecht, Icahn School of Medicine at Mount Sinai

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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: July 2020
• Actual Primary Completion Date: July 2, 2020
• Actual Study Completion Date: July 2, 2020

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Andrew C Hecht, MD; Icahn School of Medicine at Mount Sinai

More Information

• 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
• Last Update Posted: November 23, 2020
• Last Verified: November 2020

• 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:

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