NCT00891254

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

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

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

April 30, 2009

Last Update Submit

October 29, 2012

Conditions

Incisional Hernia

Keywords

Incisional herniaIntraperitoneal mesh repairOn-lay repairProsthetic meshFirst repair (no recurrent hernia will be included)RecurrenceComplications

Outcome Measures

Primary Outcomes (1)

  • Long-term recurrence

    5 years

Secondary Outcomes (1)

  • Short-term complications

    1 year

Study Arms (2)

1. Intraperitoneal repair

ACTIVE COMPARATOR

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

Device: Implant of a prosthetic mesh

2. On-Lay repair

ACTIVE COMPARATOR

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

Device: Implant of a prosthetic mesh

Interventions

Implant of a prosthetic meshDEVICE

A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study

1. Intraperitoneal repair2. On-Lay repair

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de La Serena

La Serena, Coquimbo Region, IV REGION, Chile

Location

MeSH Terms

Conditions

Incisional HerniaRecurrence

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesDisease Attributes

Study Officials

  • MARCELO A BELTRAN, M.D.

    Hospital de La Serena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DIGESTIVE SURGEON

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

July 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

CL(1)