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Adverse Events During Upper Gastrointestinal Endoscopy (AEDUGESSH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by RenJi Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Shanghai Pudong New Area People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Information provided by (Responsible Party):
diansan su, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01979549
First received: November 3, 2013
Last updated: January 20, 2014
Last verified: December 2013
  Purpose
The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population

Condition
Patients Need Upper Gastrointestinal Endoscopy
Peptic Ulcer
Gastric Cancer
Esophagus Cancer
Oesophagitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai

Resource links provided by NLM:


Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours ] [ Designated as safety issue: No ]
    Investigate the adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy with and without sedation.


Estimated Enrollment: 6000
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sedation
patients underwent upper gastrointestinal endoscopy with sedation
non-sedation
patients underwent upper gastrointestinal endoscopy without sedation

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who will undergo the upper gastrointestinal endoscopy
Criteria

Inclusion Criteria:

  • Patients will undergo upper gastrointestinal endoscopy
  • Age > 18 years old
  • Signed informed consent form

Exclusion Criteria:

  • Pregnant
  • Allergy to propofol or soybean or albumen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979549

Contacts
Contact: Diansan Su, Doctor 0086-21-68383702 diansansu@yahoo.com
Contact: Xiangrui Wang, Doctor 0086-21-68383198 wangxr2010@yahoo.com

Locations
China, Shanghai
Shanghai Tongji Hospital Recruiting
Shanghai, Shanghai, China, 200065
Contact: Xiaoqing Zhang, M.S.       xq_820175@163.com   
Principal Investigator: Xiaoqing Zhang, M.S.         
Renji hospital, School of Medicine, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Diansan Su, Doctor    0086-21-68383702    diansansu@yahoo.com   
Principal Investigator: Diansan Su, Doctor         
Shanghai Pudong New Area People's Hospital Recruiting
Shanghai, Shanghai, China
Contact: lizhi Li, M.S.       Fmlilizhi@sina.com.cn   
Principal Investigator: Lizhi Li, M.S.         
Sponsors and Collaborators
RenJi Hospital
Shanghai Pudong New Area People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Investigators
Principal Investigator: Diansan Su, Doctor Renji Hospital, School of Medicine, Shanghai Jiaotong University
  More Information

Responsible Party: diansan su, Dr., RenJi Hospital
ClinicalTrials.gov Identifier: NCT01979549     History of Changes
Other Study ID Numbers: AEDUGESSH 
Study First Received: November 3, 2013
Last Updated: January 20, 2014
Health Authority: China: Ethics Committee

Keywords provided by RenJi Hospital:
Adverse events
Upper gastrointestinal endoscopy
Sedation

Additional relevant MeSH terms:
Duodenal Diseases
Stomach Neoplasms
Esophagitis
Peptic Ulcer
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Esophageal Diseases
Gastroenteritis
Intestinal Diseases
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 30, 2016