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Clinical Trials/NCT04521985
NCT04521985
Not yet recruiting
Not Applicable

The Effectiveness of Gastroesophageal Reflux Improvement in Different Treatments in Thoracolumbar Kyphotic Patients Who Fulfill the Surgical Indications

National Taiwan University Hospital0 sites30 target enrollmentAugust 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
the GERD Occurence
Sponsor
National Taiwan University Hospital
Enrollment
30
Primary Endpoint
GERD occurrence
Status
Not yet recruiting
Last Updated
5 years ago

Overview

Brief Summary

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)

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: 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.

Registry
clinicaltrials.gov
Start Date
August 20, 2020
End Date
December 31, 2026
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

GERD occurrence

Time Frame: GERD occurence change from pre-treatment and after receiving treatent within 6 months

patients wiht GERD symptoms

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