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Hernia Repair With or Without Sutures (SONS)

Primary Purpose

Hernia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Metallic Fasteners and Sutures

Metallic Fasteners Alone

About this trial

This is an interventional treatment trial for Hernia focused on measuring Hernia repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Metallic Fasteners and Sutures

Metallic Fasteners Alone

Arm Description

Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures

Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone

Outcomes

Primary Outcome Measures

Post-op Pain

Short-Form McGill Pain Questionnaire (SFMP)

Secondary Outcome Measures

Hernia recurrence

CT Scan

Full Information

NCT ID

NCT00905320

First Posted

May 18, 2009

Last Updated

April 19, 2021

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT00905320

Brief Title

Hernia Repair With or Without Sutures

Acronym

SONS

Official Title

Sutures or No Sutures (SONS)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

November 21, 2016 (Actual)

Study Completion Date

November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia

Keywords

Hernia repair

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metallic Fasteners and Sutures

Arm Type

Active Comparator

Arm Description

Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures

Arm Title

Metallic Fasteners Alone

Arm Type

Experimental

Arm Description

Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone

Intervention Type

Procedure

Intervention Name(s)

Metallic Fasteners and Sutures

Other Intervention Name(s)

Metallic fasteners and sutures.

Intervention Description

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.

Intervention Type

Procedure

Intervention Name(s)

Metallic Fasteners Alone

Other Intervention Name(s)

Metallic fasteners alone for mesh fixation

Intervention Description

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.

Primary Outcome Measure Information:

Title

Post-op Pain

Description

Short-Form McGill Pain Questionnaire (SFMP)

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Hernia recurrence

Description

CT Scan

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Don Selzer, MD

Organizational Affiliation

Indiana University Department of Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Hernia Repair With or Without Sutures

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