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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04521985
Other study ID # 202006117RINB
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 20, 2020
Est. completion date December 31, 2026

Study information

Verified date August 2020
Source National Taiwan University Hospital
Contact Chih-Jun Lai, MD
Phone 886972652086
Email littlecherrytw@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
thoracolumbar kyphosis surgery
patients receiving surgery or not

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary GERD occurrence patients wiht GERD symptoms GERD occurence change from pre-treatment and after receiving treatent within 6 months