Evaluating the effect of bowel preparation plus oral Rifaximin on Rectum volume and Dosimetric Parameters in intravaginal High-Dose-Rate Brachytherapy for endometrial and cervical Cancer
1.rectal volume evaluation without rifaximin
2.rectal volume evaluation with rifaximin
3.rectal dosimetric parameters evaluation without rifaximin
4.rectal dosimetric parameters evaluation with rifaximin
5.effect of rifaximin on rectal dosimetric parameters
6.effect of rifaximin on rectal volume
7.effect of rectal volume on rectal dosimetric parameters with rifaximin
8.effect of rectal volume on rectal dosimetric parameters without rifaximin
Design
Two arm parallel group randomised trial without blinding postoperative treatment and outcome assessmen
Settings and conduct
24 patient who were referred to brachytherapy ward of Golestan hospital for high dose rate brachytherapy , assesed in 2 sessions . first session with bowel preparation without rifaximin and secod session with bowel preparation and with rifaximin 400 mg since 7 days before treatment to investigate the relationship between intestinal preparation with oral rifaximin on Rectal volume and dosimetric indices in high-dose intravaginal brachytherapy in cervical and cervical cancers were selected and entered into the study
Participants/Inclusion and exclusion criteria
Entry requirements: pathology based endometrial and cervical cancer, doing surgical treatment before brachytherapy, correct cylinder insertion
No entry conditions: no surgery before brachytherapy treatment, weight above 100 killogram causing not to do MRI
Intervention groups
intervention group: bowel preparation with polyethilenglycol and bisacodyl tablet since 24 hours befor trearment and also rifaximin 400 mg BD since 7 days befor treatment
control group: bowel preparation with polyethilenglycol and bisacodyl tablet since 24 hours befor trearment
Main outcome variables
Rectal volume; Rectal dose-volume parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200208046412N1
Registration date:2020-04-25, 1399/02/06
Registration timing:retrospective
Last update:2020-04-25, 1399/02/06
Update count:0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Faezeh Ebrahimian tabrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3057
Email address
ebrahimian.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2020-03-11, 1398/12/21
Actual recruitment start date
2019-09-21, 1398/06/30
Actual recruitment end date
2020-03-11, 1398/12/21
Trial completion date
2020-03-11, 1398/12/21
Scientific title
Evaluating the effect of bowel preparation plus oral Rifaximin on Rectum volume and Dosimetric Parameters in intravaginal High-Dose-Rate Brachytherapy for endometrial and cervical Cancer
Public title
Evaluating the effect of bowel preparation plus oral Rifaximin in Brachytherapy for endometrial and cervical Cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
pathology based endometrial and cervical cancer
doing surgical treatment before brachytherapy
correct cylinder insertion
Exclusion criteria:
no surgery before brachyhterapy treatment
weight above 100 killogram causing not to do MRI
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
cylindric brachytherapy session
Actual sample size reached:
24
More than 1 sample in each individual
Actual sample size in each individual:
2
cylindric brachytherapy session
Randomization (investigator's opinion)
Not 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
Ethics committee of Ahvaz University of Medical Sciences
HDR plus 3.0.8 brachytherapy , treatment planning, Bebig & Ziegler company
2
Description
Rectal Dose-volume parameters
Timepoint
Before(basement) and 7 days after oral Rifaximin
Method of measurement
HDR plus 3.0.8 brachytherapy treatment planning, Bebig & Ziegler company
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: bowel preparation with polyethilenglycol and bisacodyl tablet since 24 hours befor trearment and also rifaximin 400 mg BD since 7 days befor treatment
Category
Treatment - Drugs
2
Description
Control group: bowel preparation with polyethilenglycol and bisacodyl tablet since 24 hours befor trearment
What processes are involved for a request to access data/document
with sending request through email address or number or addresses mentioned, and after decision of scientific in charge of research, the data will be sent