Hernia Repair With or Without Sutures

Completed · Not applicable

Conditions studied: Hernia

In brief

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

Key facts

Study ID

NCT00905320

Run by

Indiana University

People needed

58

Starts

2009-09-01

Expected to finish

2018-11-21

Last updated by the study team

2021-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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