Non-Op Management of Ventral Hernia Patients

NCT ID: NCT02457364

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ventral hernias are among the most common surgical diseases among patients.The natural history of patients with ventral hernias who are managed non-operatively is unknown. The aim of this prospective trial is to document the natural history of patients who are undergoing initially non-operative management. The investigators hypothesize that 1) the risk of emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is high, and 3) patients managed non-operatively will develop increasing hernia size and symptom progression. This is a prospective observational study of all patients undergoing non-operative management at LBJ General Hospital. Patients will be consented and then followed for 5 years. Phone interviews will be done with these patients yearly to assess surgical and medical history, information about their hernia, including pain level due to the hernia, as well as function and quality of life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hernia, Ventral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients undergoing initial non-operative management as chosen by current practice patterns
* All patients who opt for non-operative management due to personal choice, lack of symptoms or concerns regarding surgical risks.
* Age 18 or older

Exclusion Criteria

* Patient meets surgery criteria but elects for surgery within 1 year due to personal scheduling
* Patient smokes \< 1 pack per day, is actively quitting smoking, and desires to follow-up within 3 months upon smoking cessation
* Patient with BMI \< 35 kg/m2, is actively losing weight, and desires to follow-up within 3 months upon weight loss goals being met
* Patient is unlikely to be able to follow-up due to no personal or home phone
* Patient is enrolled in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mike K Liang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LBJ General Hospital-UT Health

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Bedewi MA, El-Sharkawy MS, Al Boukai AA, Al-Nakshabandi N. Prevalence of adult paraumbilical hernia. Assessment by high-resolution sonography: a hospital-based study. Hernia. 2012 Feb;16(1):59-62. doi: 10.1007/s10029-011-0863-4. Epub 2011 Jul 28.

Reference Type BACKGROUND
PMID: 21796449 (View on PubMed)

Meier DE, OlaOlorun DA, Omodele RA, Nkor SK, Tarpley JL. Incidence of umbilical hernia in African children: redefinition of "normal" and reevaluation of indications for repair. World J Surg. 2001 May;25(5):645-8. doi: 10.1007/s002680020072.

Reference Type BACKGROUND
PMID: 11369993 (View on PubMed)

Lauscher JC, Martus P, Stroux A, Neudecker J, Behrens U, Hammerich R, Buhr HJ, Ritz JP. Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial. Trials. 2012 Feb 7;13:14. doi: 10.1186/1745-6215-13-14.

Reference Type BACKGROUND
PMID: 22314130 (View on PubMed)

Ah-Kee EY, Kallachil T, O'Dwyer PJ. Patient awareness and symptoms from an incisional hernia. Int Surg. 2014 May-Jun;99(3):241-6. doi: 10.9738/INTSURG-D-14-00039.1.

Reference Type BACKGROUND
PMID: 24833146 (View on PubMed)

Bellows CF, Robinson C, Fitzgibbons RJ, Webber LS, Berger DH. Watchful waiting for ventral hernias: a longitudinal study. Am Surg. 2014 Mar;80(3):245-52.

Reference Type BACKGROUND
PMID: 24666865 (View on PubMed)

Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg. 1985 Jan;72(1):70-1. doi: 10.1002/bjs.1800720127.

Reference Type BACKGROUND
PMID: 3155634 (View on PubMed)

Cevese PG, D'Amico DF, Biasiato R, Frego MG, Tropea A, Giaconi MA, Bianchera GG. Peristomal hernia following end-colostomy: a conservative approach. Ital J Surg Sci. 1984;14(3):207-9.

Reference Type BACKGROUND
PMID: 6500908 (View on PubMed)

Cherney DZ, Siccion Z, Chu M, Bargman JM. Natural history and outcome of incarcerated abdominal hernias in peritoneal dialysis patients. Adv Perit Dial. 2004;20:86-9.

Reference Type BACKGROUND
PMID: 15384802 (View on PubMed)

Eid GM, Wikiel KJ, Entabi F, Saleem M. Ventral hernias in morbidly obese patients: a suggested algorithm for operative repair. Obes Surg. 2013 May;23(5):703-9. doi: 10.1007/s11695-013-0883-5.

Reference Type BACKGROUND
PMID: 23494458 (View on PubMed)

Liu NW, Hackney JT, Gellhaus PT, Monn MF, Masterson TA, Bihrle R, Gardner TA, House MG, Koch MO. Incidence and risk factors of parastomal hernia in patients undergoing radical cystectomy and ileal conduit diversion. J Urol. 2014 May;191(5):1313-8. doi: 10.1016/j.juro.2013.11.104. Epub 2013 Dec 10.

Reference Type BACKGROUND
PMID: 24333109 (View on PubMed)

Marsman HA, Heisterkamp J, Halm JA, Tilanus HW, Metselaar HJ, Kazemier G. Management in patients with liver cirrhosis and an umbilical hernia. Surgery. 2007 Sep;142(3):372-5. doi: 10.1016/j.surg.2007.05.006.

Reference Type BACKGROUND
PMID: 17723889 (View on PubMed)

Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.

Reference Type BACKGROUND
PMID: 24022443 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-15-0372

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Occult Inguinal Hernias
NCT04815707 ACTIVE_NOT_RECRUITING PHASE2