- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01411397
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection
August 5, 2011 updated by: Mansoura University
Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair in elective situations is documented, and many studies have reported beneficial outcomes of mesh hernioplasty in emergency situations.
Still there is controversy of using such grafts in presence of intestinal resection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with acutely incarcerated hernias (with small intestine contents) who underwent polypropylene mesh hernioplasty were included in this prospective study from June 2005 through Jan. 2011, patients were categorized into 2 groups who required intestinal resection anastomosis (group I)or not (group II).
Study Type
Interventional
Enrollment (Actual)
163
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mansoura, Egypt, 35516
- Mohamed Abdellatif
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- strangulated hernias
Exclusion Criteria:
- above 75, under 18
- recurrent hernia
- peritonitis
- pure omentum contents ASA above 3
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: mesh repair
MESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION
|
REPAIR OF STRANGULATED HERNIA with intestinal resection
Other Names:
|
|
Active Comparator: mesh repair without intestinal resection
mesh repair of strangulated hernia without resection
|
mesh repair of strangulated hernia without resection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
wound infection
Time Frame: 5 weeks
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
operative time
Time Frame: 3hours
|
the time from skin incision up to skin closure
|
3hours
|
|
morbidity
Time Frame: 5 months
|
the perioperative complications
|
5 months
|
|
recurrence of the hernia
Time Frame: 6months
|
Recurrence of the hernia was defined as an apparent swelling or a palpable defect at the previous surgery site detected clinically or radiologically by ultrasound if needed
|
6months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ramadan ellithy, MD, Mansoura University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 4, 2011
First Submitted That Met QC Criteria
August 5, 2011
First Posted (Estimate)
August 8, 2011
Study Record Updates
Last Update Posted (Estimate)
August 8, 2011
Last Update Submitted That Met QC Criteria
August 5, 2011
Last Verified
June 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- strangulated hernia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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