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Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

Primary Purpose

Strangulated Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SURGERY
mesh repair
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strangulated Hernia focused on measuring Infection, Prosthesis, Recurrence, Strangulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • strangulated hernias

Exclusion Criteria:

  • above 75, under 18
  • recurrent hernia
  • peritonitis
  • pure omentum contents ASA above 3

Sites / Locations

  • Mohamed Abdellatif

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mesh repair

mesh repair without intestinal resection

Arm Description

MESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION

mesh repair of strangulated hernia without resection

Outcomes

Primary Outcome Measures

wound infection

Secondary Outcome Measures

operative time
the time from skin incision up to skin closure
morbidity
the perioperative complications
recurrence of the hernia
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

Full Information

First Posted
August 4, 2011
Last Updated
August 5, 2011
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01411397
Brief Title
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection
Official Title
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strangulated Hernia
Keywords
Infection, Prosthesis, Recurrence, Strangulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mesh repair
Arm Type
Active Comparator
Arm Description
MESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION
Arm Title
mesh repair without intestinal resection
Arm Type
Active Comparator
Arm Description
mesh repair of strangulated hernia without resection
Intervention Type
Other
Intervention Name(s)
SURGERY
Other Intervention Name(s)
mesh hernioplasty
Intervention Description
REPAIR OF STRANGULATED HERNIA with intestinal resection
Intervention Type
Other
Intervention Name(s)
mesh repair
Other Intervention Name(s)
mesh hernioplasty without resection
Intervention Description
mesh repair of strangulated hernia without resection
Primary Outcome Measure Information:
Title
wound infection
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
operative time
Description
the time from skin incision up to skin closure
Time Frame
3hours
Title
morbidity
Description
the perioperative complications
Time Frame
5 months
Title
recurrence of the hernia
Description
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
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: strangulated hernias Exclusion Criteria: above 75, under 18 recurrent hernia peritonitis pure omentum contents ASA above 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ramadan ellithy, md
Organizational Affiliation
Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Mohamed Abdellatif
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

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Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

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