Hernia Repair With or Without Sutures (SONS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00905320
First received: May 18, 2009
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Hernia
Procedure: Sutures

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)
Intervention Details:
    Procedure: Sutures
    Subjects will undergo hernia repair with mesh fixation. One type of fixation involves metallic tacks with sutures; the other type of fixation involves metallic tacks alone (no sutures).
    Other Name: Sutures or no sutures for mesh fixation in 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

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

Inclusion Criteria:

Demographics:

  • Age greater than or equal to 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 greater than 4 centimeters or less than 20 centimeters (cross-sectional diameter)
  • Multiple hernias cumulative size less than 20 cm in cross-sectional diameter
  • Body mass index (BMI = weight in kilograms/(height in meters)2) less than 40 kg/m2

Exclusion Criteria:

Demographics:

  • Body mass index (BMI = weight in kilograms/(height in meters)2) greater than 40 kg/m2

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:

    • Gastroparesis
    • Colonic inertia
    • Severe small bowel dysmotility
    • Chronic pancreatitis
    • Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
    • Chronic use of analgesics, including narcotics, or diagnosis of chronic pain from sources other than the hernia intended to be repaired
  • Allergy to products used in hernia repair including surgical mesh
  • Any abdominal ventral incisional hernia previously repaired with 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
  • Boundary of hernia less than 5 cm from costal margin, symphysis pubis, or iliac crest
  • Simultaneous presence of a bowel obstruction

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

Contacts
Contact: Don Selzer, MD 317-274-0931 dselzer@iupui.edu
Contact: Sarah Dutkevitch, RN 317-274-5495 sdutkevi@iupui.edu

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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00905320     History of Changes
Other Study ID Numbers: 0803-15
Study First Received: May 18, 2009
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Hernia repair

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014