Hernia, VentralNCT02457364
Non-Op Management of Ventral Hernia Patients
An observational study of Hernia, Ventral, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a ventral hernia who are undergoing non-operative management of their hernia at LBJ General Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LBJ General Hospital-UT Health
Houston, Texas, 77026
About this study
Official title: Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair
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.
- Conditions
- Hernia, Ventral
- Keywords
- non-operative management
- Medical subject headings
- Hernia, Ventral
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical repair of the ventral hernias per patient year
Measured: Once a year for 5 years
Secondary outcomes (3)
Rate of emergency repair of ventral hernias per patient year
Measured: Once a year for 5 years
Rate of elective repair of ventral hernias per patient year
Measured: Once a year for 5 years
Rate of emergency room visits per patient year
Measured: Once a year for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike K Liang, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457364
- Sponsor's protocol ID
- HSC-MS-15-0372
- Status last verified
- Apr 2018
- First submitted
- 20 May 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21796449Meier 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.
PubMed 11369993Lauscher 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.
PubMed 22314130Ah-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.
PubMed 24833146Bellows 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.
PubMed 24666865Mudge 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.
PubMed 3155634Cevese 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.
PubMed 6500908Cherney 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.
PubMed 15384802Eid 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.
PubMed 23494458Liu 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.
PubMed 24333109Marsman 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.
PubMed 17723889Fitzgibbons 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.
PubMed 24022443
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial of Initial Non-operative Management of Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02457364
- Acronym / sponsor ID
- HSC-MS-15-0372
- Conditions
- Hernia, Ventral
- Keywords
- non-operative management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a ventral hernia who are undergoing non-operative management of their hernia at LBJ General Hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of surgical repair of the ventral hernias per patient year
Time frame: Once a year for 5 years
3 secondary outcomes
Rate of emergency repair of ventral hernias per patient year
Time frame: Once a year for 5 years
Rate of elective repair of ventral hernias per patient year
Time frame: Once a year for 5 years
Rate of emergency room visits per patient year
Time frame: Once a year for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Background: PubMed 21796449Bedewi 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.
- Background: PubMed 11369993Meier 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.
- Background: PubMed 22314130Lauscher 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.
- Background: PubMed 24833146Ah-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.
- Background: PubMed 24666865Bellows 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.
- Background: PubMed 3155634Mudge 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.
- Background: PubMed 6500908Cevese 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.
- Background: PubMed 15384802Cherney 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.
- Background: PubMed 23494458Eid 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.
- Background: PubMed 24333109Liu 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.
- Background: PubMed 17723889Marsman 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.
- Background: PubMed 24022443Fitzgibbons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Ventral, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of surgical repair of the ventral hernias per patient year (time frame: Once a year for 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457364, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.