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Watchful Waiting of Incisional Hernias

Watchful Waiting of Incisional Hernias: A Prospective Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00351455
Enrollment
50
Registered
2006-07-12
Start date
2006-05-31
Completion date
2009-01-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia, Umbilical Hernia, Ventral Hernia

Keywords

hernia, incisional hernia, ventral hernia, umbilical hernia

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.

Interventions

BEHAVIORALsmoking cessation
BEHAVIORALtighter diabetic control
BEHAVIORALdiet and exercise program

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Develop guidelines for hernia repair—

Secondary

MeasureTime frame
To measure if life-style changes lower need for hernia repair—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026