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

Dysphagia Clinical Trial

Official title:

The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03488147
• Other study ID #: GCO 12-1433
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2020
• Est. completion date: July 2, 2020

Study information

• Verified date: November 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Deglutition Disorders
• Dysphagia
• GERD
• Joint Diseases
• Osteoarthritis

Intervention

Drug:
• Esomeprazole
20 mg esomeprazole tablet
• Placebo Oral Tablet
resembling esomeprazole tablet

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia questionnaire	The Dysphagia questionnaire is a 2 item questionnaire with full scale from 0 (no swallowing difficulty) to 10 (frequent swallowing difficulty)	12 weeks post surgery