Hernia Repair With or Without Sutures

Hernia Clinical Trial

— SONS  

Official title:

Sutures or No Sutures (SONS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905320
• Other study ID #: 0803-15
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: November 21, 2018

Study information

• Verified date: April 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia

Intervention

Procedure:
• Metallic Fasteners and Sutures
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
• Metallic Fasteners Alone
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-op Pain	Short-Form McGill Pain Questionnaire (SFMP)	12 Weeks
Secondary	Hernia recurrence	CT Scan	2 Years