Clinical trial NCT00905320: Hernia Repair With or Without Sutures
Official title: Sutures or No Sutures (SONS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: Hernia repair
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: Post-op Pain
timeFrame: 12 Weeks
Secondary outcomes:
measure: Hernia recurrence
timeFrame: 2 Years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University Department of Surgery
name: Don Selzer, MD
role: PRINCIPAL_INVESTIGATOR
References: