HerniaSONSNCT00905320
Hernia Repair With or Without Sutures
A study testing Metallic Fasteners and Sutures and Metallic Fasteners Alone in people with Hernia, run by Indiana University at 1 site in United States.
Trial summary
This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- Metallic Fasteners and Sutures and Metallic Fasteners Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 21 Nov 2018
- Phase
- Interventional
- 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
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sutures or No Sutures (SONS)
This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.
Read the detailed description
This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.
Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.
- Conditions
- Hernia
- Being tested
- Metallic Fasteners and Sutures, Metallic Fasteners Alone
- Keywords
- Hernia repair
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metallic Fasteners and SuturesProcedure or surgery
Also called Metallic fasteners and sutures.
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
Metallic Fasteners AloneProcedure or surgery
Also called Metallic fasteners alone for mesh fixation
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.
| Study group | Role | What they receive |
|---|---|---|
| Metallic Fasteners and Sutures | Active comparator | Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures Receives: Procedure: Metallic Fasteners and Sutures |
| Metallic Fasteners Alone | Experimental | Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone Receives: Procedure: Metallic Fasteners Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-op Pain
Short-Form McGill Pain Questionnaire (SFMP)
Measured: 12 Weeks
Secondary outcomes (1)
Hernia recurrence
CT Scan
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startSep 2009
- Primary completion21 Nov 2016
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Selzer, Indiana University
- Investigators
- Don Selzer, MD, Principal investigator, Indiana University Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905320
- Sponsor's protocol ID
- 0803-15
- Acronym
- SONS
- Status last verified
- Apr 2021
- First submitted
- 18 May 2009
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutures or No Sutures (SONS)
- ClinicalTrials.gov ID
- NCT00905320
- Acronym / sponsor ID
- SONS / 0803-15
- Conditions
- Hernia
- Keywords
- Hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 20 May 2009 (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.
This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.
Detailed description
This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.
Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metallic Fasteners and Sutures | Active comparator | Procedure: Metallic Fasteners and SuturesLaparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures |
| Metallic Fasteners Alone | Experimental | Procedure: Metallic Fasteners AloneLaparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old
- If female, negative pregnancy test
- 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
Key exclusion criteria (15 listed)
- Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.
- History of the following:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metallic Fasteners and SuturesAlso: Metallic fasteners and sutures.Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures. | Procedure or surgery | Metallic Fasteners and Sutures |
| Metallic Fasteners AloneAlso: Metallic fasteners alone for mesh fixationSubjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone. | Procedure or surgery | Metallic Fasteners Alone |
Primary outcome
Post-op Pain
Time frame: 12 Weeks
Short-Form McGill Pain Questionnaire (SFMP)
1 secondary outcome
Hernia recurrence
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Don Selzer, MD principal investigator
Indiana University Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metallic Fasteners and Sutures and Metallic Fasteners Alone in people with Hernia, run by Indiana University 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 20 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-op Pain (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2021.