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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia
• GERD
• Degenerative Joint Disease

Interventions

Type	Name	Description
DRUG	Esomeprazole	20 mg esomeprazole tablet
DRUG	Placebo Oral Tablet	resembling esomeprazole tablet

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-07-02
• Completion: 2020-07-02
• First posted: 2018-04-04
• Last updated: 2020-11-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study