Hernia Repair With or Without Sutures (SONS)

This study is currently recruiting participants.
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
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 April 15, 2014