Sutures or No Sutures (SONS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hernia
- Sponsor
- Indiana University
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Post-op Pain
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Don Selzer
Associate Professor of Surgery
Indiana University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Post-op Pain
Time Frame: 12 Weeks
Short-Form McGill Pain Questionnaire (SFMP)
Secondary Outcomes
- Hernia recurrence(2 Years)