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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of surgical repair of the ventral hernias per patient year | Once a year for 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of emergency repair of ventral hernias per patient year | Once a year for 5 years | |
| Rate of elective repair of ventral hernias per patient year | Once a year for 5 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain from baseline using the Visual Analog Scale for Pain | Once a year for 5 years | |
| Change in patient function from baseline using the HerQLes Survey | Once a year for 5 years | |
Inclusion Criteria:
Exclusion Criteria:
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All patients with a ventral hernia who are undergoing non-operative management of their hernia at LBJ General Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LBJ General Hospital-UT Health | Houston | Texas | 77026 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21796449 | Background | 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. | |
| 11369993 | Background | 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. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Rate of emergency room visits per patient year |
| Once a year for 5 years |
| Change in patient quality of life from baseline using the HerQLes Survey |
| Once a year for 5 years |
| Change in hernia size based on clinical exam or CT scan | Once a year for 5 years |
| 22314130 | Background | 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. |
| 24833146 | Background | 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. |
| 24666865 | Background | 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. |
| 3155634 | Background | 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. |
| 6500908 | Background | 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. |
| 15384802 | Background | 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. |
| 23494458 | Background | 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. |
| 24333109 | Background | 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. |
| 17723889 | Background | 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. |
| 24022443 | Background | 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. |