Hernia Repair With or Without Sutures

Not Applicable

Completed

• Conditions: Hernia

• Registration Number: NCT00905320
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Study Start: 2009-09
• Primary Completion: 2016-11-21
• Study Completion: 2018-11-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-op Pain	12 Weeks	Short-Form McGill Pain Questionnaire (SFMP)

Secondary Outcome Measures

Name	Time	Method
Hernia recurrence	2 Years	CT Scan

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States