Watchful Waiting of Incisional Hernias

NCT ID: NCT00351455

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-01-31

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.

Conditions

Incisional Hernia; Ventral Hernia; Umbilical Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

smoking cessation

Intervention Type: BEHAVIORAL

tighter diabetic control

Intervention Type: BEHAVIORAL

diet and exercise program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Daniel Musher

Distinguished Service Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Bellows, III, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Countries

United States

Other Identifiers

H-18609

Identifier Type: -

Identifier Source: org_study_id