the GERD Occurence Clinical Trial
Official title:
The Effectiveness of Gastroesophageal Reflux Improvement in Different Treatments in Thoracolumbar Kyphotic Patients Who Fulfill the Surgical Indications
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)
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:
1. To determine whether acid or weakly acidic reflux in to the esophagus decreases after
patients receiving treatment.
2. To investigate the change of esophageal motility after patients receiving treatment.
3. 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.
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