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

Phase 2

Withdrawn

• Conditions: Degenerative Joint Disease; Dysphagia; GERD
• Interventions: Drug: Placebo Oral Tablet; Drug: Esomeprazole

• Registration Number: NCT03488147
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Study Start: 2020-07
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Tablet Only	Placebo Oral Tablet	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
Esomeprazole and Placebo Oral Tablet	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.
Esomeprazole Only	Esomeprazole	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
Esomeprazole and Placebo Oral Tablet	Esomeprazole	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.

Primary Outcome Measures

Name	Time	Method
Dysphagia questionnaire	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)

Trial Locations

Locations (2)

Mount Sinai West; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States