Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351455
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2006-07-07
Brief Title:
Watchful Waiting of Incisional Hernias
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Watchful Waiting of Incisional Hernias A Prospective Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1 who decline to have surgery to repair the hernia or 2 patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed A comparison will be made between those who receive surgery and those who do not
Detailed Description:
This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1 who decline to have surgery to repair the hernia or 2 patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed A comparison will be made between those who receive surgery and those who do not
Subjects will fill out three survey forms on quality of life and pain at baseline and again at six and 12 months Measurements of change in hernia size will be made life-style changes such as smoking cessation weight-loss tighter control of diabetes will be initiated for outcome comparison with controls
Subjects will fill out three survey forms on quality of life and pain at baseline and again at six and 12 months Measurements of change in hernia size will be made life-style changes such as smoking cessation weight-loss tighter control of diabetes will be initiated for outcome comparison with controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None