Thorcolumbar Kyphosis Patients With GERD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: thoracolumbar kyphosis surgery.
- Who it may be relevant to
- Registry conditions: the GERD Occurence. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effectiveness of Gastroesophageal Reflux Improvement in Different Treatments in Thoracolumbar Kyphotic Patients Who Fulfill the Surgical Indications
Overview
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.
Interventions
- Procedure thoracolumbar kyphosis surgery
patients receiving surgery or not
Primary outcome measures
- GERD occurrence [Time frame: GERD occurence change from pre-treatment and after receiving treatent within 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04521985 · 202006117RINB