Mesh Hernioplasty Of Strangulated Hernias With Intestinal... | NCT01411397

Studies
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

NCT01411397

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Aug 8, 2011Estimated

Enrollment

163Actual

Phase

Not Applicable

Conditions

Strangulated Hernia

Interventions

SURGERY
mesh repair

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Aug 4, 2011

First Submission Date that Met QC Criteria

Aug 5, 2011

First Posted Date

Aug 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2011

Last Update Posted Date

Aug 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mesh repair	Active Comparator	MESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION	Other: SURGERY
mesh repair without intestinal resection	Active Comparator	mesh repair of strangulated hernia without resection	Other: mesh repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SURGERY	Other	REPAIR OF STRANGULATED HERNIA with intestinal resection	mesh repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound infection		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
operative time	the time from skin incision up to skin closure	3hours
morbidity	the perioperative complications	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

strangulated hernias

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ramadan ellithy, md	Mansoura University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohamed Abdellatif		Al Mansurah	Mansoura	35516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D012008	Recurrence

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided