Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

Strangulated Hernia Clinical Trial

Official title:

Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411397
• Other study ID #: strangulated hernia
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: August 5, 2011
• Start date: June 2005
• Est. completion date: January 2011

Study information

• Verified date: June 2005
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• strangulated hernias

Exclusion Criteria:

• above 75, under 18

• recurrent hernia

• peritonitis

• pure omentum contents ASA above 3

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Strangulated Hernia

Intervention

Other:
• SURGERY
REPAIR OF STRANGULATED HERNIA with intestinal resection
• mesh repair
mesh repair of strangulated hernia without resection

Locations

Country	Name	City	State
Egypt	Mohamed Abdellatif	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound infection		5 weeks	Yes
Secondary	operative time	the time from skin incision up to skin closure	3hours	Yes
Secondary	morbidity	the perioperative complications	5 months	Yes
Secondary	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	6months	Yes