Hernia Repair With or Without Sutures

Study Overview
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Brief Summary
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This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.

Detailed Description
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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.

Official Title
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Sutures or No Sutures (SONS)

Conditions
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Hernia

Intervention / Treatment
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* Procedure: Metallic Fasteners and Sutures
* Procedure: Metallic Fasteners Alone


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metallic Fasteners and Sutures<br>Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures | Procedure: Metallic Fasteners and Sutures<br>* Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.<br>* Other names: Metallic fasteners and sutures.;|
| Experimental: Metallic Fasteners Alone<br>Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone | Procedure: Metallic Fasteners Alone<br>* Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.<br>* Other names: Metallic fasteners alone for mesh fixation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op Pain | Short-Form McGill Pain Questionnaire (SFMP) | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | CT Scan | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia repair