Clinical trial NCT03488147: 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
Official title: The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dysphagia
GERD
Degenerative Joint Disease
Keywords: Esomeprazole Magnesium
Postoperative dysphagia
Gastroesophageal reflux disease
Anterior cervical surgery
Proton pump inhibitor
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Dysphagia questionnaire
timeFrame: 12 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew C Hecht, MD
role: PRINCIPAL_INVESTIGATOR
References: