NCT00459602

Brief Summary

The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

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

Study Start

First participant enrolled

August 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

4.1 years

First QC Date

April 10, 2007

Last Update Submit

March 25, 2015

Conditions

Incisional Hernia

Keywords

laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Visual analog (VAS) scale

    pain assessment

    1 year

Study Arms (1)

Laparoscopic incisional hernia repair

Subjects with an incisional, ventral, umbilical, or spigelian hernia no larger tham 15 cm at the largest measurement, who are candidates for laparoscopic repair of the hernia, and who are able to commit to long-term followup. Laparoscopic repair will proceed as per the standard technique, using polyester mesh.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical clinic

You may qualify if:

  • incisional hernia suitable for repair by laparoscopic techniques

You may not qualify if:

  • not a candidate for laparoscopic surgery
  • hernia not suitable for laparoscopic repair techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Dennis L Fowler, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 12, 2007

Study Start

August 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)