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Trial registered on ANZCTR


Registration number
ACTRN12611000723987
Ethics application status
Approved
Date submitted
7/07/2011
Date registered
12/07/2011
Date last updated
12/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
pedicled seromuscular flap for enforcement of high risk intestinal anastomoses
Scientific title
pedicled seromuscular flap for enforcement of high risk intestinal anastomoses to assess the efficacy and safety of this flap as a protective additional layer for such anastomoses
Secondary ID [1] 262589 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
high risk intestinal anastomoses 268272 0
Condition category
Condition code
Surgery 268407 268407 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
resection of the diseased portion of the intestine and making end to end anastomosis then enforcing the anastomotic area with a seromuscular flap, about 2 hours procedure , performed for 30 patients
Intervention code [1] 266928 0
Treatment: Surgery
Comparator / control treatment
making end to end anastomosis in the control group without flap enforcement
Control group
Active

Outcomes
Primary outcome [1] 269164 0
intestinal leak assessed by intestinal content coming out through the wound, or through the drain tube inserted beside the anastomosis
Timepoint [1] 269164 0
the first 5 postoperative weeks
Secondary outcome [1] 279049 0
wound complications including infection or desruption which can be assessed by signs of infection of the wound like cellulitis
Timepoint [1] 279049 0
the first 5 postoperative weeks

Eligibility
Key inclusion criteria
all patients who undwerwent resection anastomosis in presence of peritonitis that make the anastomosis high risk to fail to heal
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
all patients who underwent surgery in presence of peritonitis were included in the study there were no exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
case matched control study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
each case was matched to a control in terms of age, gender, diagnosis, and associated comorbid diseases
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3702 0
Egypt
State/province [1] 3702 0

Funding & Sponsors
Funding source category [1] 267401 0
University
Name [1] 267401 0
mansoura university
Country [1] 267401 0
Egypt
Primary sponsor type
University
Name
mansoura university
Address
eljomheyah street-35516-mansoura
Country
Egypt
Secondary sponsor category [1] 266458 0
Hospital
Name [1] 266458 0
mansoura university hospital
Address [1] 266458 0
eljomheyah street-35516-mansoura
Country [1] 266458 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269370 0
local health committee
Ethics committee address [1] 269370 0
eljomheyah street-35516-mansoura-department of surgery
Ethics committee country [1] 269370 0
Egypt
Date submitted for ethics approval [1] 269370 0
01/03/2009
Approval date [1] 269370 0
28/03/2009
Ethics approval number [1] 269370 0

Summary
Brief summary
the primery purpose of our study was to assess if enforcing the anastomosis with this seromuscular flap is safe, feasible and effective or not by observing and comparing the incidence of anastomotic leakage between the case group and the control group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32847 0
Address 32847 0
Country 32847 0
Phone 32847 0
Fax 32847 0
Email 32847 0
Contact person for public queries
Name 16094 0
mohamed abdellatif
Address 16094 0
eljomheyah street-35516-mansoura
Country 16094 0
Egypt
Phone 16094 0
+20115051680
Fax 16094 0
Email 16094 0
[email protected]
Contact person for scientific queries
Name 7022 0
mohamed abdellatif
Address 7022 0
eljomheyah street-35516-mansoura
Country 7022 0
Egypt
Phone 7022 0
+20115051680
Fax 7022 0
Email 7022 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.