We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adverse Events During Upper Gastrointestinal Endoscopy (AEDUGESSH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by diansan su, RenJi Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979549
First Posted: November 8, 2013
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 diansan su, 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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 3, 2013
First Posted: November 8, 2013
Last Update Posted: January 22, 2014
Last Verified: December 2013

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

Additional relevant MeSH terms:
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
Duodenal Diseases
Intestinal Diseases
Head and Neck Neoplasms


To Top