Hernia Repair With or Without Sutures (SONS)

Indiana University

Status

Completed

Conditions

Hernia

Treatments

Procedure: Metallic Fasteners Alone

Procedure: Metallic Fasteners and Sutures

Study type

Interventional

Funder types

Other

Identifiers

NCT00905320

0803-15

Details and patient eligibility

About

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

Full 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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.