Watchful Waiting of Incisional Hernias

Not Applicable

Completed

• Conditions: Incisional Hernia; Umbilical Hernia; Ventral Hernia

• Registration Number: NCT00351455
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-07-07
• Study First Submitted QC: 2006-07-11
• Study First Posted: 2006-07-12
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. abdominal hernia greater than 3 cm2
2. 18 years of age
3. able to give informed consent

Exclusion Criteria

1. abdominal hernia less than 3 cm2 or greater than 127 cm2
2. unable to return to clinic for follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Develop guidelines for hernia repair

Secondary Outcome Measures

Name	Time	Method
To measure if life-style changes lower need for hernia repair

Trial Locations

Locations (1)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States