Gastrointestinal Motor Disorders (Esophageal and Anorectal) in Patients After COVID-19 Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Measurement of anorectal parameters 1 on manometry
研究概览
简要总结
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal disorder (esophageal and anorectal) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.
详细描述
The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal (esophageal and anorectal disorder) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.
The patients with dysphagia, chest discomfort during swallowing, or chest pain during swallowing, patients with obstipation, fecal evacuation symptoms, lower stomach discomfort before defecation etc. will be included in the study. In all of them other gastrointestinal diseases will be excluded by standard routine laboratory investigation, ultrasound, routine endoscopy investigation and 24 hours impedance pH-measurement.
After manometric measurement of esophagus and anorectal region to standard protocol by using MMS-HRM 360 monitoring system with 36 canals catheter for esophagus and 24 canals catheter for anorectal monitoring, data will be calculated by using statistics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with esophageal and anorectal symptoms after COVID 19- infection
- •Patients with worsening of esophageal and anorectal symptom after COVID 19- infection, but who had previously described esophageal and anorectal symptoms
排除标准
- •Other gastrointestinal disease that can influence to results
- •Gastroesophageal reflux
- •H. Pylori infection
- •Bacterial, parasitic, viral and fungal gastrointestinal infection or infestation
- •Myasthenia
- •Scleroderma
- •Diabetes mellitus
- •Thyroidal hyperfunction
结局指标
主要结局
Measurement of anorectal parameters 1 on manometry
时间窗: 2 years
On anorectal manometry we will measure Resting test pressure in mmHg.
Measurement of anorectal parameters 2 on manometry
时间窗: 2 years
On anorectal manometry we will measure Squeeze test pressure in mmHg.
Measurement of anorectal parameters 3 on manometry
时间窗: 2 years
On anorectal manometry we will measure Endurance squeeze test pressure in mmHg.
Measurement of anorectal parameters 7 on manometry
时间窗: 2 years
On anorectal manometry we will measure Balloon expulsion test as positive or negative.
Measurement of esophageal parameters 3 on manometry
时间窗: 120 days
In esophagus we will measure Contractile front velocity (CVF) in cm/s.
Measurement of esophageal parameters 4 on manometry
时间窗: 120 days
In esophagus we will measure Distal contractile integral (DCI) in mmHg.s.cm.
Measurement of esophageal parameters 1 on manometry
时间窗: 120 days
In esophagus we will measure Upper and lower esophageal sphincter pressure in mmHg.
Measurement of esophageal parameters 5 on manometry
时间窗: 120 days
In esophagus we will measure Distal latency (DL) in seconds.
Measurement of esophageal parameters 6 on manometry
时间窗: 120 days
In esophagus we will measure Peristaltic brake (BR) in cm.
Measurement of esophageal parameters 2 on manometry
时间窗: 120 days
In esophagus we will measure Integrated relaxation pressure (IRP) in mmHg.
Measurement of anorectal parameters 4 on manometry
时间窗: 2 years
On anorectal manometry we will measure recto-anal inhibitory reflex test (RAIR)- relaxation in percent.
Measurement of anorectal parameters 5 on manometry
时间窗: 2 years
On anorectal manometry we will measure Push test pressure in mmHg.
Measurement of anorectal parameters 6 on manometry
时间窗: 2 years
On anorectal manometry we will measure Sensation test with ml in balloon.
次要结局
未报告次要终点
研究者
Žarko Babić
Principal investigator, Clinical professor, Heat of Interventional gastroenterology
University Hospital Dubrava