Solitary rectal ulcer syndrome (SRUS) is an uncommon disorder of evacuation. Management of bleeding ulcers is usually unsatisfactory with conventional treatments. Argon plasma coagulation (APC) has been reported in case reports to control bleeding; however, it has not been shown to result in ulcer healing. The aims of study were to investigate the efficacy and safety of APC in controlling bleeding from SRUS and to study its efficacy in eventual healing of ulcers. A randomized, controlled trial of the management of 58 consecutive patients with SRUS was done in the gastroenterology unit of IMMAM Hospital. Main Outcome Measurements were Control of bleeding and endoscopic healing of SRUS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112258521N1
Registration date:2012-11-16, 1391/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-16, 1391/08/26
Registrant information
Name
Farzad Jassemi Zergani
Name of organization / entity
Ahvaz Jundishapur university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3477
Email address
shams-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Argon plasma coagulation (APC) in healing of bleeding Solitary rectal ulcer in Comparison with Conventional Therapy
Public title
Effect of argon plasma coagulation in management of bleeding solitary rectal ulcers.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: rectal ulcer that has a histologic features of SRUS witch confirmed with a pathologist. Exclusion criteria: a rectal ulcer that did not has a histologic features of SRUS.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz jundishapur university of medical sciences
Street address
university town
City
Ahvaz
Postal code
61357-15794
Approval date
2011-12-17, 1390/09/26
Ethics committee reference number
ETH - 307
Health conditions studied
1
Description of health condition studied
Ulcer of anus and rectum
ICD-10 code
K62.6
ICD-10 code description
Ulcer of anus and rectum
Primary outcomes
1
Description
management and healing of bleeding solitary rectal ulcers
Timepoint
every 4 weeks after stating the study-3 months after the end of last APC
Method of measurement
observing with colonoscope
Secondary outcomes
1
Description
evaluation of complications-costs and values of procedures
Timepoint
from the onset until the end of study.
Method of measurement
viewing and calculation
Intervention groups
1
Description
Treatment device intervention was related to patients that received argon plasma coagulation treatment in order to control bleeding and healing of rectal ulcers. This gas directed in focused fashion toward the lesions.
Category
Treatment - Devices
2
Description
Intervention related to control group was, use of high-fiber diets, laxative, explain and discuss about the nature of a disease and it was recommended to use the toilet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Immam hospital
Full name of responsible person
Dr. F. Jassemi Zergani, fellow of Gastroenterology
Street address
Ahvaz Immam hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Dr. Mahammadreza Abaspur
Street address
university town, Ahvaz jundishapur university of medical sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz jundishapur university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Dr. F. Jassemi Zergani
Position
fellow of Gastroenterology
Other areas of specialty/work
Street address
Ahvaz jundishapur university of medical sciences - university town
City
Ahvaz
Postal code
Phone
+98 61 1373 8383
Fax
Email
fjassemi49@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Dr. F. Jassemi Zergani
Position
fellow of Gastroenterology
Other areas of specialty/work
Street address
university town, Ahvaz jundishapur university of medical sciences
City
Ahvaz
Postal code
Phone
+98 61 1337 8031
Fax
Email
fjassemi49@yahoo.com ; shams-s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Full name of responsible person
Dr. F. Jassemi Zergani
Position
fellow of Gastroenterology
Other areas of specialty/work
Street address
university town
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8383
Fax
+98 61 1337 8031
Email
fjassemi49@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)