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Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01411397
First received: August 4, 2011
Last updated: August 5, 2011
Last verified: June 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • wound infection [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

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

  • morbidity [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    the perioperative complications

  • recurrence of the hernia [ Time Frame: 6months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411397

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

No publications provided

Responsible Party: mansoura university
ClinicalTrials.gov Identifier: NCT01411397     History of Changes
Other Study ID Numbers: strangulated hernia
Study First Received: August 4, 2011
Last Updated: August 5, 2011
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Mansoura University:
Infection
Prosthesis
Recurrence
Strangulation

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013