Non-Op Management of Ventral Hernia Patients

Hernia, Ventral Clinical Trial

Official title:

Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02457364
• Other study ID #: HSC-MS-15-0372
• Status: Active, not recruiting
• Start date: July 2015
• Est. completion date: June 2020

Study information

• Verified date: April 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 143
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Locations

Country	Name	City	State
United States	LBJ General Hospital-UT Health	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

Cévese 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg. 1985 Jan;72(1):70-1. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in pain from baseline using the Visual Analog Scale for Pain		Once a year for 5 years
Other	Change in patient function from baseline using the HerQLes Survey		Once a year for 5 years
Other	Change in patient quality of life from baseline using the HerQLes Survey		Once a year for 5 years
Other	Change in hernia size based on clinical exam or CT scan		Once a year for 5 years
Primary	Rate of surgical repair of the ventral hernias per patient year		Once a year for 5 years
Secondary	Rate of emergency repair of ventral hernias per patient year		Once a year for 5 years
Secondary	Rate of elective repair of ventral hernias per patient year		Once a year for 5 years
Secondary	Rate of emergency room visits per patient year		Once a year for 5 years