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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT00905320 |
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Date of registration:
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18/05/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hernia Repair With or Without Sutures
SONS |
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Scientific title:
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Sutures or No Sutures (SONS) |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00905320 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Don Selzer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University Department of Surgery |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Demographics:
- Age = 18 years old
- If female, negative pregnancy test
Pre-Operative Findings:
- Presence of an abdominal hernia associated with previous surgical incision
- Midline ventral\incisional hernia demonstrated either on physical examination by
investigators or radiologic imaging tests.
- CT scan, MRI, Ultrasound
- No evidence of incarceration, strangulation
- Size of hernia = 4 centimeters or = 20 centimeters (cross-sectional diameter)
- Multiple hernias cumulative size = 20 centimeters in cross-sectional diameter
Exclusion Criteria:
Pre-Operative History:
- Severe medical co-morbidities that prevent safe performance of laparoscopic surgery
including coronary artery disease, obstructive pulmonary disease, etc.
- History of the following:
- Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
- Chronic use (defined as greater than 3 months) of narcotic analgesic for pain
other than from the hernia that is intended to be repaired
- Allergy to products used in hernia repair including surgical mesh
- Any abdominal ventral incisional hernia previously repaired with permanent synthetic
mesh placed inside the peritoneal cavity
- Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of
the abdominal musculature and fascia)
- Presence of simultaneous intra-abdominal infection
- Simultaneous presence of a bowel obstruction
- History of suspected or known addiction to or abuse of illicit drug(s), prescription
medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
opinion of the Investigator, may interfere with study assessments or compliance.
Intra-operative Findings:
- Simultaneous performance of another surgical procedure during hernia repair other than
acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)
- Intra-operative identification of full thickness injury to intestine (i.e.
enterotomy), liver, bladder, etc.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hernia
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Intervention(s)
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Procedure: Metallic Fasteners Alone
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Procedure: Metallic Fasteners and Sutures
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Primary Outcome(s)
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Post-op Pain
[Time Frame: 12 Weeks]
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Secondary Outcome(s)
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Hernia recurrence
[Time Frame: 2 Years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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