UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006083 |
|---|---|
| Receipt number | R000007202 |
| Scientific Title | Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection . |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2011/07/31 07:11:33 |
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Basic information
Public title
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection .
Acronym
mesh repair and intestinal resection
Scientific Title
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection .
Scientific Title:Acronym
mesh repair and intestinal resection
Region
| Africa |
Condition
Condition
strangulated hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
mesh hernioplasty with intestinal resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
rate of wound infection
Key secondary outcomes
operative times,hospital stay, recurrence, mortality, and pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
mesh hernioplasty with intestinal resection
Interventions/Control_2
mesh hernioplasti without intestinal resection
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all patients between 18- 75 who underwent emergency mesh hernioplasty for their incarcerated hernias with small intestine contents were included in this study (whether inguinal, femoral, umbilical, or incisional) .
Key exclusion criteria
excluding those with Child's C score liver cirrhosis with tense ascitis, colonic resection or those with incarcerated omentum only, ASA above 3, recurrent hernias, patients who had incarcerated hernias that developed perforations, generalized peritonitis and who were lost at follow up
Target sample size
163
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | mohamed abdellatif |
Organization
mansoura university
Division name
surgery
Zip code
Address
35516-egypt
TEL
+20502070665
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | mohamed abdellatif |
Organization
mansoura university
Division name
surgery
Zip code
Address
35516-egypt
TEL
+20502070665
Homepage URL
surg_latif@hotmail.com
Sponsor or person
Institute
mansoura university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 31 | Day |
Last modified on
| 2011 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007202
