- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521985
Thorcolumbar Kyphosis Patients With GERD
The Effectiveness of Gastroesophageal Reflux Improvement in Different Treatments in Thoracolumbar Kyphotic Patients Who Fulfill the Surgical Indications
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: the investigator aimed to investigate the gastroesophageal reflux disease (GERD) along with esophageal motility in thoracolumbar kyphotic patients who meet surgical spinal correction criteria. Because some patients refused to receive spinal correction surgery, our patients divided into surgical and non-surgical treatment (for example: brace) groups. The investigator intended to use (1) multichannel intraluminal impedance-pH (MII-pH) monitoring to assess the height, non-acidic and acidic regurgitation of gastroesophageal reflux disease (GERD) (2) high resolution impedance manometry (HRIM) to esophageal motility between pretreatment and posttreatment period. (3) the questionnaire to evaluate the reflux-related symptoms: the frequency scale for the symptoms of GERD (FSSG), gastrointestinal symptom rating scale (GSRS) and Carlsson-Dent self-administered questionnaire (QUEST)
Objectives:
- To determine whether acid or weakly acidic reflux in to the esophagus decreases after patients receiving treatment.
- To investigate the change of esophageal motility after patients receiving treatment.
- To determine whether the GERD symptoms would get improved after surgical or nonsurgical treatment.
Patients and methods: After the surgeon explained the spinal correction surgery, patients decided to recieve the correction surgery or wear brace treatment. Three types of evaluation were conducted in (1) patients receiving surgical correction [preoeprative and postoeprative surgical spinal correction (within 6 months)] (2) patients receiving brace treatment for 3 month [pretreament and wearing brace after 3 month within 6 months]; namely, HRIM, 24h MII-pH monitoring and three different questionniare surveys: the freqeuncy scale for the symptoms of GERD (FSSG), gastrointestinal symptom rating scale (GSRS) and Carlsson-Dent self administered questionniare (QUEST).The primary outcome was to evaluate the efficacy of surgical spinal correction for GERD by questionniare in patients with severe kyphotic deformity.
Expected result: 1.To precisely estimate efficacy of kyphosis surgical correction and brace treatment 2. To determine whether spinal correction for kyphosis patients with GERD is a surgical indication for the treatment of GERD along with for the treatment of kyphotic deformity.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chih-Jun Lai, MD
- Phone Number: 886972652086
- Email: littlecherrytw@gmail.com
Study Contact Backup
- Name: Fon-Yih Tsuang, MD,PhD
- Phone Number: 886972651442
- Email: tsuangfy@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with thoracolumbar kyphotic deformity meet the surgical correction indication. These thoracolumbar kyphotic deformity caused by osteoporossis, multiple vertebral fractures, adult idiopathic scoliosis, camptocormia as a result of Parkinson's disease, degenrative de novo kyphoscoliosis or
Exclusion Criteria:
- Age less than 20 year old
- Previous history of abdominal operation, including the esophagus and stomach.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
thoracolumbar kyphosis
patients undergoing thoracolumbar kyphosis surgery
|
patients receiving surgery or not
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GERD occurrence
Time Frame: GERD occurence change from pre-treatment and after receiving treatent within 6 months
|
patients wiht GERD symptoms
|
GERD occurence change from pre-treatment and after receiving treatent within 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202006117RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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