NCT01821326

Brief Summary

The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

January 25, 2017

Completed
Last Updated

January 25, 2017

Status Verified

November 1, 2016

Enrollment Period

10.6 years

First QC Date

March 23, 2013

Results QC Date

November 20, 2013

Last Update Submit

November 30, 2016

Conditions

Gastrointestinal Bleeding

Keywords

capsule endoscopyobscure gastrointestinal bleedingrebleedingrisk factors

Outcome Measures

Primary Outcomes (1)

  • Rebleeding Rate

    10 years

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent CE in Shanghai Renji Hospital ( China )from June 2002 to January 2012 for OGIB

You may qualify if:

  • Patients who underwent capsule endoscopy in Shanghai Renji Hospital(China) from June 2002 to January 2012 for obscure gastrointestinal bleeding

You may not qualify if:

  • patients who did not undergo a gastroscopy and colonoscopy performed before capsule endoscopy examination; and
  • patients with follow-up examination for other know clinical diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr.Zhizheng GE
Organization
Shanghai Jiaotong University
tanwei_1987@163.com
86-68383015

Study Officials

  • Zhizheng Ge, M.D. PhD.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterology,

Study Record Dates

First Submitted

March 23, 2013

First Posted

April 1, 2013

Study Start

June 1, 2002

Primary Completion

January 1, 2013

Last Updated

January 25, 2017

Results First Posted

January 25, 2017

Record last verified: 2016-11