Incisional Hernia Outcomes Study Using Parietex Composite Mesh

Columbia University

Status: Terminated

Conditions: Incisional Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT00459602

AAAA7985

Details and patient eligibility

About

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.

Full description

For subjects who agree to participate in this study, participation will last for 1 year. Subjects will undergo all the routine preoperative testing, the same as would be required if they were not participating in this study. This testing includes a blood sample and an electrocardiogram (ECG). Follow up visits will be done at 2 weeks after surgery, 6 weeks after surgery, and 1 year after surgery. Except for the 1 year visit, these office visits are routine and would be requested even if you were not participating in this study. At each of these visits, subjects will be asked about their level of pain and the amount and type of pain medication their are taking. Data gathered for this study will be on outcomes only.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• incisional hernia suitable for repair by laparoscopic techniques

Exclusion criteria

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

Trial design

22 participants in 1 patient group

Laparoscopic incisional hernia repair

Description:

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.