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Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Phase 1
Locations
Chile
Study Type
Interventional
Intervention
Implant of a prosthetic mesh
Sponsored by
Cirujanos la Serena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia focused on measuring Incisional hernia, Intraperitoneal mesh repair, On-lay repair, Prosthetic mesh, First repair (no recurrent hernia will be included), Recurrence, Complications

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
  • First repair
  • Older than 35 years of age and younger than 75 years of age
  • Both genders
  • Any BMI
  • Only upper abdominal midline incisional hernias (supraumbilical)
  • Patients submitted only to elective repair

Exclusion Criteria:

  • Recurrent incisional hernia
  • Emergency surgery
  • Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
  • Lower midline abdominal incisional hernias
  • Other hernias rather than midline incisional hernias
  • Non-incisional hernias

Sites / Locations

  • Hospital de La Serena

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1. Intraperitoneal repair

2. On-Lay repair

Arm Description

Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery

Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery

Outcomes

Primary Outcome Measures

Long-term recurrence

Secondary Outcome Measures

Short-term complications

Full Information

First Posted
April 30, 2009
Last Updated
October 29, 2012
Sponsor
Cirujanos la Serena
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1. Study Identification

Unique Protocol Identification Number
NCT00891254
Brief Title
Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
Official Title
Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cirujanos la Serena

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair. The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
Keywords
Incisional hernia, Intraperitoneal mesh repair, On-lay repair, Prosthetic mesh, First repair (no recurrent hernia will be included), Recurrence, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Intraperitoneal repair
Arm Type
Active Comparator
Arm Description
Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery
Arm Title
2. On-Lay repair
Arm Type
Active Comparator
Arm Description
Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
Intervention Type
Device
Intervention Name(s)
Implant of a prosthetic mesh
Intervention Description
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
Primary Outcome Measure Information:
Title
Long-term recurrence
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Short-term complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2) First repair Older than 35 years of age and younger than 75 years of age Both genders Any BMI Only upper abdominal midline incisional hernias (supraumbilical) Patients submitted only to elective repair Exclusion Criteria: Recurrent incisional hernia Emergency surgery Hernias with a diameter higher than 5 cm or more than 25 cm2 of area Lower midline abdominal incisional hernias Other hernias rather than midline incisional hernias Non-incisional hernias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARCELO A BELTRAN, M.D.
Organizational Affiliation
Hospital de La Serena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de La Serena
City
La Serena
State/Province
Iv Region
ZIP/Postal Code
IV REGION
Country
Chile

12. IPD Sharing Statement

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Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

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