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Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411397
First Posted: August 8, 2011
Last Update Posted: August 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mansoura University
  Purpose
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.

Condition Intervention
Strangulated Hernia Other: SURGERY Other: mesh repair

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • wound infection [ Time Frame: 5 weeks ]

Secondary Outcome Measures:
  • operative time [ Time Frame: 3hours ]
    the time from skin incision up to skin closure

  • morbidity [ Time Frame: 5 months ]
    the perioperative complications

  • 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


Enrollment: 163
Study Start Date: June 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mesh repair
MESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION
Other: SURGERY
REPAIR OF STRANGULATED HERNIA with intestinal resection
Other Name: mesh hernioplasty
Active Comparator: mesh repair without intestinal resection
mesh repair of strangulated hernia without resection
Other: mesh repair
mesh repair of strangulated hernia without resection
Other Name: mesh hernioplasty without resection

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • strangulated hernias

Exclusion Criteria:

  • above 75, under 18
  • recurrent hernia
  • peritonitis
  • pure omentum contents ASA above 3
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411397


Locations
Egypt
Mohamed Abdellatif
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Study Director: ramadan ellithy, md Mansoura University
  More Information

Responsible Party: mansoura university
ClinicalTrials.gov Identifier: NCT01411397     History of Changes
Other Study ID Numbers: strangulated hernia
First Submitted: August 4, 2011
First Posted: August 8, 2011
Last Update Posted: August 8, 2011
Last Verified: June 2005

Keywords provided by Mansoura University:
Infection
Prosthesis
Recurrence
Strangulation

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical