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CompletedNCT00891254Updated Oct 31, 2012

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

A Phase 1 interventional study of Implant of a prosthetic mesh in Incisional Hernia, sponsored by Cirujanos la Serena. Completed at 1 site in Chile. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-31.

Sponsored by Cirujanos la Serena · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Incisional Hernia

Keywords

  • Incisional hernia
  • Intraperitoneal mesh repair
  • On-lay repair
  • Prosthetic mesh
  • First repair (no recurrent hernia will be included)
  • Recurrence
  • Complications
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Cirujanos la Serena is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    1. Intraperitoneal repair

    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

  • Active comparator
    2. On-Lay repair

    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

  • DeviceImplant of a prosthetic mesh

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

06

What researchers measure

Primary outcomes

  1. Long-term recurrence

    Time frame: 5 years

Secondary outcomes

  1. Short-term complications

    Time frame: 1 year

07

Study locations

1 site
  • Hospital de La Serena
    La Serena, Iv Region IV REGION, Chile
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00891254
Lead sponsor
Cirujanos la Serena
Responsible party
MARCELO A. BELTRAN, M.D. (DIGESTIVE SURGEON, Cirujanos la Serena) — Principal investigator
First posted
May 1, 2009
Start date
Jan 2009
Primary completion
Jan 2011
Completion
Jul 2012
Last update
Oct 31, 2012

Study contacts

MARCELO A BELTRAN, M.D.
principal investigator · Hospital de La Serena

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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