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Prophylactic Injection Therapy Reduces Recurrent Bleeding In Forrest Type IIb Duodenal Ulcers

B

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status

Completed

Conditions

Duodenal Ulcer Bleeding

Treatments

Procedure: prophylactic injection therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01471496
konuk-001

Details and patient eligibility

About

The purpose of this study is to determine whether prophylactic injection therapy reduces recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent bleeding.

Full description

The benefit of endoscopic therapy in ulcers with adherent clots on their surface is still uncertain. A prophylactic injection therapy may reduce the recurrent bleeding rate at this group of patients having this endoscopic stigma of recent bleeding. This type of ulcers are named as type IIb duodenal ulcers according to Forrest's classification, They cary the risk of bleeding recurrence up to 36 percent and as it is reported previously there may be a 12 fold increasement in morbidity and mortality in such cases. A prophylactic endoscopic injection therapy may reduce the risk of recurrent bleeding in this group of the patients.

Enrollment

80 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Endoscopic diagnose of Forrest type 2b duodenal ulcer.

Exclusion criteria

  • Patients at whom the onset of Upper Gastrointestinal system bleeding symptoms exceeded 24 hours at index endoscopy.
  • Patients having hemodynamic instability: systolic blood pressure below 90 mm/hg, heart rate above 110/min
  • Demonstration of hemoglobin fall more than 2 g/dl in two hours.
  • Patients with coexisting ulcers elsewhere than in duodenum.
  • Patients under anticoagulant therapy other than Aspirin.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

prophylactic injection therapy group
Experimental group
Description:
In addition to medical therapy which included 2x 30 mg Pantoprazole and intravenous fluids this group of the patients recieved injection therapy.
Treatment:
Procedure: prophylactic injection therapy
control group
No Intervention group
Description:
This group of the patients recieved medical therapy only.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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