NCT02457364

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

4.9 years

First QC Date

May 20, 2015

Last Update Submit

April 30, 2018

Conditions

Hernia, Ventral

Keywords

non-operative management

Outcome Measures

Primary Outcomes (1)

  • Rate of surgical repair of the ventral hernias per patient year

    Once a year for 5 years

Secondary Outcomes (3)

  • 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

  • Rate of emergency room visits per patient year

    Once a year for 5 years

Other Outcomes (4)

  • 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

  • Change in patient quality of life from baseline using the HerQLes Survey

    Once a year for 5 years

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a ventral hernia who are undergoing non-operative management of their hernia at LBJ General Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LBJ General Hospital-UT Health

Houston, Texas, 77026, United States

Location

Related Publications (12)

  • 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.

    PMID: 21796449BACKGROUND

  • 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.

    PMID: 11369993BACKGROUND

  • 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.

    PMID: 22314130BACKGROUND

  • 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.

    PMID: 24833146BACKGROUND

  • 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.

    PMID: 24666865BACKGROUND

  • 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.

    PMID: 3155634BACKGROUND

  • 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.

    PMID: 6500908BACKGROUND

  • 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.

    PMID: 15384802BACKGROUND

  • 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.

    PMID: 23494458BACKGROUND

  • 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.

    PMID: 24333109BACKGROUND

  • 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.

    PMID: 17723889BACKGROUND

  • 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.

    PMID: 24022443BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 29, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

US(1)