Trial Outcomes & Findings for Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease (NCT NCT00972088)

Results Overview

The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

up to 7 days

Results posted on

2013-06-24

Participant Flow

from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics

patients were enrolled to undergo capsule endoscopy of the small bowel if they had perianal disease and a negative colonoscopy with ileoscopy or a negative colonoscopy with a negative small bowel series or negative ct enterography

Participant milestones

Participant milestones
Measure	a Single Arm Group, Patients With Ano Rectal Disease patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anorectal Disease, Negative Work up for Crohns Disease n=26 Participants Patients presently suffering from anorectal abscess or anorectal fistula
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	34.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Israel	26 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 7 days

Population: per protocol

The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.

Outcome measures

Outcome measures
Measure	Anorectal Disease, Negative Work up for Crohns Disease n=26 Participants Patients presently suffering from anorectal abscess or anorectal fistula
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy	6 participants

Adverse Events

Anorectal Disease, Negative Work up for Crohns Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

samuel n adler md, director of clinical trial

bikur holim hospital

Phone: 972 2 6464206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place