NCT00775034

Brief Summary

Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 27, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2014

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

4.7 years

First QC Date

October 16, 2008

Last Update Submit

June 22, 2018

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • Hospital stay

    At time of discharge

Secondary Outcomes (5)

  • Postoperative drainage volume

    Day 0,1, 2, 3 ? and at day of removal

  • Perioperative morbidity rate

    At time of discharge

  • Pain measured using VAS

    Daily till discharge and after 3 weeks post-surgery

  • Quality of life by SF-36 questionnaire

    Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery

  • Recurrence

    At one year

Study Arms (2)

1

EXPERIMENTAL

Study group (Tisseel®)

Drug: Tisseel®

2

OTHER

Control group

Procedure: Drainage

Interventions

Tisseel®DRUG

Mesh repair for open incisional hernia repair with fibrin sealant

1
DrainagePROCEDURE

Mesh repair for open incisional hernia repair with drainage

2

Eligibility Criteria

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

You may qualify if:

  • All patients with a large incisional hernia \>5cm diameter that needs elective repair with mesh augmentation

You may not qualify if:

  • no written informed consent
  • 'hostile' abdomen
  • emergency surgery (incarcerated hernia)
  • parastomal hernia
  • incisional hernia outside the midline
  • recurrent incisional hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Ghent

Ghent, 9000, Belgium

Location

UZ gasthuisberg Leuven

Leuven, Belgium

Location

Related Links

MeSH Terms

Conditions

Incisional Hernia

Interventions

Fibrin Tissue AdhesiveDrainage

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsTherapeuticsSurgical Procedures, Operative

Study Officials

  • Frederik Berrevoet, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

January 27, 2010

Primary Completion

October 14, 2014

Study Completion

May 24, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

BE(2)