Watchful Waiting of Incisional Hernias

Incisional Hernia Clinical Trial

Official title:

Watchful Waiting of Incisional Hernias: A Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351455
• Other study ID #: H-18609
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: January 2009

Study information

• Verified date: May 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Hernia, Ventral
• Incisional Hernia
• Umbilical Hernia
• Ventral Hernia

Intervention

Behavioral:
• smoking cessation

• tighter diabetic control

• diet and exercise program

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop guidelines for hernia repair
Secondary	To measure if life-style changes lower need for hernia repair