Hernia Repair With or Without Sutures (SONS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Indiana University
Information provided by (Responsible Party):
Don Selzer, Indiana University
ClinicalTrials.gov Identifier:
First received: May 18, 2009
Last updated: August 31, 2015
Last verified: August 2015
This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.

Condition Intervention
Procedure: Metallic Fasteners and Sutures
Procedure: Metallic Fasteners Alone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sutures or No Sutures (SONS)

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pain [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hernia recurrence [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2009
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metallic Fasteners and Sutures
Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures
Procedure: Metallic Fasteners and Sutures
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
Other Name: Metallic fasteners and sutures.
Experimental: Metallic Fasteners Alone
Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone
Procedure: Metallic Fasteners Alone
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.
Other Name: Metallic fasteners alone for mesh fixation

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905320

Contact: Don Selzer, MD 317-274-0931 dselzer@iupui.edu
Contact: Maryanne Bowyer-Cherry, RN 317-274-0172 mbowyer@iupui.edu

United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Don Selzer, MD         
Sponsors and Collaborators
Indiana University
Principal Investigator: Don Selzer, MD Indiana University Department of Surgery
  More Information

No publications provided

Responsible Party: Don Selzer, Associate Professor of Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT00905320     History of Changes
Other Study ID Numbers: 0803-15
Study First Received: May 18, 2009
Last Updated: August 31, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Hernia repair

Additional relevant MeSH terms:
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2015