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NCT00775034 Clinical Trial

Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Incisional Hernia Clinical Trial

— DREAM  

Official title:
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00775034
Other study ID # 2008/433
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 27, 2010
Est. completion date May 24, 2018

Study information
Verified date June 2018
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date May 24, 2018
Est. primary completion date October 14, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- no written informed consent

- 'hostile' abdomen

- emergency surgery (incarcerated hernia)

- parastomal hernia

- incisional hernia outside the midline

- recurrent incisional hernia

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tisseel®
Mesh repair for open incisional hernia repair with fibrin sealant
Procedure:
• Drainage
Mesh repair for open incisional hernia repair with drainage

Locations
Country Name City State
Belgium University Hospital Ghent Ghent
Belgium UZ gasthuisberg Leuven Leuven

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Baxter Healthcare Corporation

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital stay At time of discharge
Secondary Postoperative drainage volume Day 0,1, 2, 3 ? and at day of removal
Secondary Perioperative morbidity rate At time of discharge
Secondary Pain measured using VAS Daily till discharge and after 3 weeks post-surgery
Secondary 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
Secondary Recurrence At one year
See also
  Status Clinical Trial Phase
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Recruiting NCT05734222 - Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias N/A
Enrolling by invitation NCT03105895 - Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI N/A
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT02089958 - Standardization of Laparoscopic Hernia Repair N/A
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Terminated NCT00498810 - COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL) N/A
Completed NCT04961346 - RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair N/A
Terminated NCT03912662 - ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention N/A
Recruiting NCT05620121 - ACute Treatment of Incisional Ventral Hernia
Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Not yet recruiting NCT05568238 - Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen N/A
Not yet recruiting NCT02896686 - Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure Phase 4
Recruiting NCT02277262 - PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM) Phase 4
Active, not recruiting NCT02328352 - "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" Phase 1/Phase 2
Suspended NCT01520168 - Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management N/A
Recruiting NCT05579652 - Change in Fascial Tension in Open Abdomens
Active, not recruiting NCT03390764 - Hernia After Colorectal Cancer Surgery N/A
Completed NCT02321059 - Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia N/A

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