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NCT Number: NCT04521985

Thorcolumbar Kyphosis Patients With GERD

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)

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thoracolumbar kyphosis surgery

Procedure

patients receiving surgery or not

Primary outcomes

  1. GERD occurrence

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

    patients wiht GERD symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Jun Lai, MD

CONTACT

[email protected]

886972652086

Fon-Yih Tsuang, MD,PhD

CONTACT

[email protected]

886972651442

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.