NCT00498810

Brief Summary

To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

4 months

First QC Date

July 9, 2007

Last Update Submit

January 27, 2011

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

    1 year

Secondary Outcomes (4)

  • Perioperative morbidity rate

  • Postoperative pain

  • Long term complication rate

  • Recurrence rate

    3 years

Interventions

complete repairPROCEDURE
partial repair of the abdominal wallPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Written informed consent from the patient or his/her legal representative
  • Incisional hernia requiring elective surgical repair

You may not qualify if:

  • No written informed consent
  • Emergency surgery (incarcerated hernia)
  • All incisional or parastomal hernias not originating at the midline
  • All recurrent hernias
  • All patients with mesh placed intra-abdominally during surgery have to be withdrawn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Frederik Berrevoet, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

BE(1)