Hernia Repair With or Without Sutures (SONS)

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

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.

Inclusion Criteria:

Demographics:

• Age greater than or equal to 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 greater than 4 centimeters or less than 20 centimeters (cross-sectional diameter)
• Multiple hernias cumulative size less than 20 cm in cross-sectional diameter
• Body mass index (BMI = weight in kilograms/(height in meters)2) less than 40 kg/m2

Exclusion Criteria:

Demographics:

• Body mass index (BMI = weight in kilograms/(height in meters)2) greater than 40 kg/m2

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:

  • Gastroparesis
  • Colonic inertia
  • Severe small bowel dysmotility
  • Chronic pancreatitis
  • Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
  • Chronic use of analgesics, including narcotics, or diagnosis of chronic pain from sources other than the hernia intended to be repaired
• Allergy to products used in hernia repair including surgical mesh
• Any abdominal ventral incisional hernia previously repaired with 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
• Boundary of hernia less than 5 cm from costal margin, symphysis pubis, or iliac crest
• Simultaneous presence of a bowel obstruction

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.