Hernia
Conditions
Keywords
Hernia repair
Brief summary
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.
Interventions
PROCEDUREMetallic Fasteners and Sutures
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
PROCEDUREMetallic Fasteners Alone
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-op Pain | 12 Weeks | Short-Form McGill Pain Questionnaire (SFMP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | 2 Years | CT Scan |
Countries
United States
Outcome results
None listed