NCT00240188

Brief Summary

The purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

Enrollment Period

2.8 years

First QC Date

August 30, 2005

Last Update Submit

September 15, 2010

Conditions

Hernia, Ventral

Keywords

HerniaIncisionalLaparoscopicMeshRepairVentral

Outcome Measures

Primary Outcomes (1)

  • Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type

    Eight (8) weeks post-operatively

Secondary Outcomes (1)

  • Compare pain, return to normal activities of daily living, and return to work. Health related quality of life, and recurrence.

    One (1) and two (2) years post-operatively

Study Arms (1)

1

OTHER
Procedure: Open mesh repair of ventral incisional herniaProcedure: Laparoscopic mesh repair of ventral incisional hernia

Interventions

Open mesh repair of ventral incisional herniaPROCEDURE

For the open procedure, the technique, as described by Chevrel and others was adopted.

1
Laparoscopic mesh repair of ventral incisional herniaPROCEDURE

For the laparoscopic repair, the method of Gagner was adopted

1

Eligibility Criteria

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

You may qualify if:

  • Patients will be eligible for enrollment into the study if they meet the following criteria: -Are 18 years of age or older -Have a diagnosis of ventral primary incisional hernia 9-225 cm2 in size. -Give informed consent for randomization - Have a negative pregnancy test. (Women)

You may not qualify if:

  • Patients will be excluded for the following reasons: -Hernia cannot be detected on physical examination - Primary ventral or umbilical hernia - Small hernia defined as less than 9 cm2 - Giant hernia defined as greater than 225 cm2 in size - ASA class 4 or 5, or contraindications to general anesthesia - Severe co morbid conditions likely to limit survival to less than 3 years - History of malignancy within the past 5 years except for non-melanoma skin cancer - Cirrhosis with or without ascites - Presence of bowel obstruction( partial or intermittent), strangulation, peritonitis, or perforation. - Presence of local or systemic infection - Participation in another clinical trial - Emergency operation - Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System, Boston

Boston, Massachusetts, 02130, United States

Location

Related Publications (5)

  • Kaafarani HM, Hur K, Campasano M, Reda DJ, Itani KM. Classification and valuation of postoperative complications in a randomized trial of open versus laparoscopic ventral herniorrhaphy. Hernia. 2010 Jun;14(3):231-5. doi: 10.1007/s10029-009-0593-z. Epub 2010 Mar 6.

    PMID: 20213456RESULT

  • Kaafarani HM, Kaufman D, Reda D, Itani KM. Predictors of surgical site infection in laparoscopic and open ventral incisional herniorrhaphy. J Surg Res. 2010 Oct;163(2):229-34. doi: 10.1016/j.jss.2010.03.019. Epub 2010 Apr 1.

    PMID: 20605590RESULT

  • Itani KM, Neumayer L, Reda D, Kim L, Anthony T. Repair of ventral incisional hernia: the design of a randomized trial to compare open and laparoscopic surgical techniques. Am J Surg. 2004 Dec;188(6A Suppl):22S-29S. doi: 10.1016/j.amjsurg.2004.09.006.

    PMID: 15610889RESULT

  • Kaafarani HM, Hur K, Hirter A, Kim LT, Thomas A, Berger DH, Reda D, Itani KM. Seroma in ventral incisional herniorrhaphy: incidence, predictors and outcome. Am J Surg. 2009 Nov;198(5):639-44. doi: 10.1016/j.amjsurg.2009.07.019.

    PMID: 19887192RESULT

  • Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18.

    PMID: 20404280RESULT

MeSH Terms

Conditions

Hernia, VentralHerniaSurgical Wound

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Kamal Itani, MD

    VA Boston Healthcare System, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 30, 2005

First Posted

October 17, 2005

Study Start

February 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations

US(1)