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Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

Primary Purpose

Surgical Wound

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rebleeding
Sponsored by
The Second People's Hospital of GuangDong Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Surgical Wound focused on measuring obscure gastrointestinal bleeding, laparoscopy, angiography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- melena or hematochezia receive at least 2 times upper gastrointestinal endoscopy nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy endoscopies were performed by experienced endoscopists.

Exclusion Criteria:

- < 18 years, pregnant moribund conditions terminal malignancy contrast allergy impaired renal function (serum creatinine > 150 µmol/l)

Sites / Locations

  • The Second People's Hospital of GuangDong Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

angiography combination laparoscopy

angiography alone

Arm Description

All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence. Those who developed rebleeding during the observation would be crossed over to the other investigation modality. Patients with negative findings on the initial assigned investigation but who developed rebleeding would undergo further investigation to localize the site of bleeding.

All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence.

Outcomes

Primary Outcome Measures

diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding
The primary outcome of this study was the diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding.

Secondary Outcome Measures

rebleeding rates
Secondary outcome measures included long-term rebleeding rates, further hospital admissions for bleeding or anemia, further blood transfusion, and death.

Full Information

First Posted
February 15, 2014
Last Updated
February 19, 2014
Sponsor
The Second People's Hospital of GuangDong Province
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1. Study Identification

Unique Protocol Identification Number
NCT02069262
Brief Title
Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding
Official Title
Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2003
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second People's Hospital of GuangDong Province

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There were many approaches for patients with obscure gastrointestinal bleeding (OGIB). Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy, laparoscopy, computed tomography and angiography have been recommended as investigation. However, of these techniques, the evaluation and management of patients with OGIB remains a formidable challenge. We compared the diagnostic yield and long-term outcomes of patients with OGIB randomized to angiogram combination laparoscopy or angiogram alone.
Detailed Description
Consecutive patients who presented with OGIB to the second people's hospital of GuangDong province between January 2003 and November 2008 were recruited. This study was approved by the ethical committee of the Second people's Hospital of GuangDong Province and was designed according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. All patients gave written informed consent before beginning the study. As a standard protocol, all patients presented with melena or hematochezia would receive at least 2 times upper gastrointestinal endoscopy before admission. Patients who had nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy before admission. All gastrointestinal endoscopies were performed by experienced endoscopists (hanning Wang). OGIB were defined as patients who had nondiagnostic upper endoscopy and colonoscopy. Patients who were < 18 years, pregnant, in moribund conditions, or with terminal malignancy were excluded. Patients with contrast allergy and impaired renal function (serum creatinine > 150 µmol/l) were also not eligible for this study. All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
obscure gastrointestinal bleeding, laparoscopy, angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
angiography combination laparoscopy
Arm Type
Experimental
Arm Description
All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence. Those who developed rebleeding during the observation would be crossed over to the other investigation modality. Patients with negative findings on the initial assigned investigation but who developed rebleeding would undergo further investigation to localize the site of bleeding.
Arm Title
angiography alone
Arm Type
Placebo Comparator
Arm Description
All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence.
Intervention Type
Other
Intervention Name(s)
rebleeding
Other Intervention Name(s)
angiography, laparoscopy
Intervention Description
Those who developed rebleeding during the observation would be crossed over to the other investigation modality.
Primary Outcome Measure Information:
Title
diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding
Description
The primary outcome of this study was the diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding.
Time Frame
5 years after initial examination
Secondary Outcome Measure Information:
Title
rebleeding rates
Description
Secondary outcome measures included long-term rebleeding rates, further hospital admissions for bleeding or anemia, further blood transfusion, and death.
Time Frame
follow-up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - melena or hematochezia receive at least 2 times upper gastrointestinal endoscopy nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy endoscopies were performed by experienced endoscopists. Exclusion Criteria: - < 18 years, pregnant moribund conditions terminal malignancy contrast allergy impaired renal function (serum creatinine > 150 µmol/l)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kaiyun chen, phD
Organizational Affiliation
The Second People's Hospital of GuangDong Province
Official's Role
Study Chair
Facility Information:
Facility Name
The Second People's Hospital of GuangDong Province
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510317
Country
China

12. IPD Sharing Statement

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Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

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