NCT00351455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

July 7, 2006

Last Update Submit

May 9, 2023

Conditions

Incisional HerniaVentral HerniaUmbilical Hernia

Keywords

herniaincisional herniaventral herniaumbilical hernia

Outcome Measures

Primary Outcomes (1)

  • Develop guidelines for hernia repair

Secondary Outcomes (1)

  • To measure if life-style changes lower need for hernia repair

Interventions

smoking cessationBEHAVIORAL
tighter diabetic controlBEHAVIORAL
diet and exercise programBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • abdominal hernia greater than 3 cm2
  • years of age
  • able to give informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Incisional HerniaHernia, VentralHernia, UmbilicalHernia

Interventions

Diet

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesHernia, AbdominalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Charles Bellows, III, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Service Professor of Medicine

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 12, 2006

Study Start

May 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

US(1)