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CompletedNCT01420757COLIBRIUpdated Aug 22, 2011

Laparoscopic Versus Open Incisional Hernia Repair

A Phase 3 interventional study of incisional hernia repair in Postoperative Pain, Complications and Recurrence, sponsored by Erasmus Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-22.

Sponsored by Erasmus Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.

The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.

02

Conditions studied

  • Postoperative Pain
  • Complications
  • Recurrence

Keywords

  • operation time
  • length of hospital stay
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 206 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • hernia diameter between 3 and 15 cm
  • location at the ventral abdominal wall at least 5cm from costae and inguinal area
  • indication for elective repair
  • age of 18 years or older
  • written informed consent.

Exclusion criteria

Exclusion Criteria:

  • contraindication for pneumoperitoneum
  • an absolute contraindication for general anesthesia
  • history of open abdomen treatment
  • patients participating in other trials
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
206 participants (actual)

Study arms

  • Active comparator
    open

    open incisional hernia repair

    Procedure: incisional hernia repair

  • Active comparator
    laparoscopic

    laparoscopic incisional hernia repair

    Procedure: incisional hernia repair

Interventions

  • Procedureincisional hernia repair

    Tension-free open or laparoscopic incisional hernia repair

06

What researchers measure

Primary outcomes

  1. Postoperative pain

    Time frame: 4 weeks

Secondary outcomes

  1. Postoperative analgesics use

    Time frame: 1 week

  2. complications

    Time frame: 4 weeks

  3. operation time

    Time frame: 1 day

  4. length of hospital stay

    Time frame: 4 weeks

  5. recurrence

    Time frame: 5 years

  6. mortality

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01420757
Lead sponsor
Erasmus Medical Center
Responsible party
hasan eker (Prof. Dr. J.F. Lange, Erasmus Medical Center) — Principal investigator
First posted
Aug 22, 2011
Start date
May 1999
Primary completion
Dec 2006
Completion
Jul 2011
Last update
Aug 22, 2011

Study contacts

J.F. Lange, MD, PhD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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