Status:
COMPLETED
Hernia Repair With or Without Sutures
Lead Sponsor:
Indiana University
Conditions:
Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00905320
Start Date
September 1 2009
End Date
November 21 2018
Last Update
April 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University
Indianapolis, Indiana, United States, 46202