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Trial registered on ANZCTR


Registration number
ACTRN12609000633280
Ethics application status
Approved
Date submitted
23/07/2009
Date registered
29/07/2009
Date last updated
29/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regenerated Oxidized Cellulose Reinforcement of Low Rectal Anastomosis
Scientific title
Regenerated Oxidized Cellulose Reinforcement of Low Rectal Anastomosis in adults with mid and low rectal cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low rectal anastomosis 237337 0
Condition category
Condition code
Surgery 239660 239660 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients had stapled straight low colorectal or colo-anal anastomosis for low rectal cancer without proximal diversion. Patients were prospectively randomized to either regenerated oxidized cellulose reinforcement (OCR) or no reinforcement (NR). Data collected included: age, sex, hemoglobin %, albumin level, histopathologic type of the tumor. Reinforcement was done by integration of the regenerated oxidized cellulose (ROC) in the staple line of the anastomosis. The regenerated oxidized cellulose is incorporated in the staple anastomotic line. procedure usually takes 30 mins
Intervention code [1] 237000 0
Treatment: Other
Comparator / control treatment
Non reinforced groups is done through double stapled colorectal anastomosis using circular stapler 29mm. done on all cases in the non reinforced group. Anastomosis procedure usually take 30 min
Control group
Active

Outcomes
Primary outcome [1] 238436 0
Leak rate will be assesed both clinically and using computerized tomography (CT) with contrast
Timepoint [1] 238436 0
30 days post surgery
Secondary outcome [1] 244937 0
Nil
Timepoint [1] 244937 0
nil

Eligibility
Key inclusion criteria
Adults with mid and low rectal cancer
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
refusal of randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1916 0
Egypt
State/province [1] 1916 0

Funding & Sponsors
Funding source category [1] 237385 0
Hospital
Name [1] 237385 0
Alexandria University hospitals
Address [1] 237385 0
El ghorfa el togaria street, El Raml Station, Alexandria, 21321
Country [1] 237385 0
Egypt
Primary sponsor type
Hospital
Name
Alexandria University hospitals
Address
El ghorfa el togaria street, El Raml Station, Alexandria, 21321
Country
Egypt
Secondary sponsor category [1] 236885 0
None
Name [1] 236885 0
Address [1] 236885 0
Country [1] 236885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239517 0
Alexandria university
Ethics committee address [1] 239517 0
Kolyt el Teb street, El Raml Station, Alexandria, 21321
Ethics committee country [1] 239517 0
Egypt
Date submitted for ethics approval [1] 239517 0
Approval date [1] 239517 0
01/06/2003
Ethics approval number [1] 239517 0

Summary
Brief summary
Incidence of leak from low rectal anastomosis is high and diversion is usually needed. Reinforcement of anastomsis might help to decrease leak. Purpose of this work is to study the effect of reinforcing stapled low rectal anastomosis with regenerated oxidized cellulose on the incidence of anastomotic leak.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29953 0
Address 29953 0
Country 29953 0
Phone 29953 0
Fax 29953 0
Email 29953 0
Contact person for public queries
Name 13200 0
Khaled madbouly
Address 13200 0
131 port said street, Ibrahimia, alexandria, 21322
Country 13200 0
Egypt
Phone 13200 0
20102033676
Fax 13200 0
Email 13200 0
kmadbouly@yahoo.com
Contact person for scientific queries
Name 4128 0
Khaled madbouly
Address 4128 0
131 port said street, Ibrahimia, alexandria, 21322
Country 4128 0
Egypt
Phone 4128 0
20102033676
Fax 4128 0
Email 4128 0
kmadbouly@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary