NCT01420757

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P50-P75 for phase_3 postoperative-pain

Timeline
Completed

Started May 1999

Longer than P75 for phase_3 postoperative-pain

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

May 1, 1999

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
Last Updated

August 22, 2011

Status Verified

August 1, 2011

Enrollment Period

7.6 years

First QC Date

August 18, 2011

Last Update Submit

August 19, 2011

Conditions

Postoperative PainComplicationsRecurrence

Keywords

operation timelength of hospital stay

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    4 weeks

Secondary Outcomes (6)

  • Postoperative analgesics use

    1 week

  • complications

    4 weeks

  • operation time

    1 day

  • length of hospital stay

    4 weeks

  • recurrence

    5 years

  • +1 more secondary outcomes

Study Arms (2)

open

ACTIVE COMPARATOR

open incisional hernia repair

Procedure: incisional hernia repair

laparoscopic

ACTIVE COMPARATOR

laparoscopic incisional hernia repair

Procedure: incisional hernia repair

Interventions

incisional hernia repairPROCEDURE

Tension-free open or laparoscopic incisional hernia repair

laparoscopicopen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeRecurrence

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsDisease Attributes

Study Officials

  • J.F. Lange, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. J.F. Lange

Study Record Dates

First Submitted

August 18, 2011

First Posted

August 22, 2011

Study Start

May 1, 1999

Primary Completion

December 1, 2006

Study Completion

July 1, 2011

Last Updated

August 22, 2011

Record last verified: 2011-08