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



Status:Not yet recruiting
Conditions:Gastroesophageal Reflux Disease , Osteoarthritis (OA), Orthopedic, Gastrointestinal
Therapuetic Areas:Gastroenterology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2, 2018
End Date:April 2, 2020
Contact:Komal Srivastava
Email:Komal.Srivastava@mountsinai.org
Phone:212-241-6605

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

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.

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.

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.
We found this trial at
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New York, New York 10025
Principal Investigator: Andrew C Hecht, MD
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Andrew C Hecht, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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