NCT01411397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
Last Updated

August 8, 2011

Status Verified

June 1, 2005

Enrollment Period

5.6 years

First QC Date

August 4, 2011

Last Update Submit

August 5, 2011

Conditions

Strangulated Hernia

Keywords

InfectionProsthesisRecurrenceStrangulation

Outcome Measures

Primary Outcomes (1)

  • wound infection

    5 weeks

Secondary Outcomes (3)

  • operative time

    3hours

  • morbidity

    5 months

  • recurrence of the hernia

    6months

Study Arms (2)

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

SURGERYOTHER

REPAIR OF STRANGULATED HERNIA with intestinal resection

Also known as: mesh hernioplasty
mesh repair
mesh repairOTHER

mesh repair of strangulated hernia without resection

Also known as: mesh hernioplasty without resection
mesh repair without intestinal resection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • strangulated hernias

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abdellatif

Al Mansurah, Mansoura, 35516, Egypt

Location

MeSH Terms

Conditions

InfectionsRecurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ramadan ellithy, md

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 8, 2011

Study Start

June 1, 2005

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

August 8, 2011

Record last verified: 2005-06

Locations

EG(1)