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SONS: Hernia Repair With or Without Sutures

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT00905320
Collaborator
(none)
58
Enrollment
1
Location
2
Arms
110.7
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Metallic Fasteners and Sutures
  • Procedure: Metallic Fasteners Alone
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Sutures or No Sutures (SONS)
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Nov 21, 2016
Actual Study Completion Date :
Nov 21, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Metallic fasteners alone for mesh fixation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-op Pain [12 Weeks]

      Short-Form McGill Pain Questionnaire (SFMP)

    Secondary Outcome Measures

    1. Hernia recurrence [2 Years]

      CT Scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Don Selzer, MD, Indiana University Department of Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Don Selzer, Associate Professor of Surgery, Indiana University
    ClinicalTrials.gov Identifier:
    NCT00905320
    Other Study ID Numbers:
    • 0803-15
    First Posted:
    May 20, 2009
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Don Selzer, Associate Professor of Surgery, Indiana University
    Hernia repair
    Additional relevant MeSH terms:
    Hernia

    Study Results

    No Results Posted as of Apr 20, 2021