Hernia Repair With or Without Sutures (SONS)

Sutures or No Sutures (SONS)

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

Study Overview

• Status: Completed
• Conditions: Hernia
• Intervention / Treatment: Procedure: Metallic Fasteners and Sutures; Procedure: Metallic Fasteners Alone

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-op Pain	Short-Form McGill Pain Questionnaire (SFMP)	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	CT Scan	2 Years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: May 18, 2009
• First Submitted That Met QC Criteria: May 19, 2009
• First Posted (Estimate): May 20, 2009

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Hernia repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 0803-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No