Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

Surgical Wound Clinical Trial

Official title:

Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069262
• Other study ID #: ABT-2004-208
• Secondary ID: ABT2004208
• Status: Completed
• Phase: N/A
• First received: February 15, 2014
• Last updated: February 19, 2014
• Start date: January 2003
• Est. completion date: January 2014

Study information

• Verified date: January 2003
• Source: The Second People's Hospital of GuangDong Province
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2014
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Surgical Wound

Intervention

Other:
• rebleeding
Those who developed rebleeding during the observation would be crossed over to the other investigation modality.

Locations

Country	Name	City	State
China	The Second People's Hospital of GuangDong Province	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Second People's Hospital of GuangDong Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years after initial examination	Yes
Secondary	rebleeding rates	Secondary outcome measures included long-term rebleeding rates, further hospital admissions for bleeding or anemia, further blood transfusion, and death.	follow-up to 5 years	Yes